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JSS UNIVERSITY

SRI SHIVARATHREESHWARA NAGAR

MYSORE – 570 015

REGULATIONS AND SYLLABUS

Revised Regulations - 2012

BACHELOR OF PHARMACY (B.PHARM) COURSE

March- 2012

1

JSS University Sri Shivarathreeshwara Nagar

Mysore – 570 015

Bachelor of Pharmacy (B.Pharm) course

REGULATIONS

These regulations shall be called as ―The Regulations for the B. Pharmacy Degree course of the J.S.S.

University, Mysore‖.

They shall come into force from the Academic Year 2012 - 2013.

The regulations framed are subject to modifications from time to time by the authorities of the university

Minimum qualification for admission to the course

1. Candidates who have passed two year P.U.C./P.D.C/H.S.C (10+2) examination or an equivalent

examination of any approved Board or university with not less than 40% marks in any

combination comprising Physics, Chemistry and Mathematics (PCM) or Physics, Chemistry and

Biology (PCB) or Physics, chemistry, mathematics and Biology (PCMB)

Note: In respect of candidates who have taken P.C.M.B. Combination the aggregate of P.C.M. or

P.C.B. whichever is higher shall be considered for the purpose of admission.

2. In case of students belonging to SC/ST/or Category-I, the minimum percentage of marks for

admission to B. Pharm Course shall be not less than 35% in P.D.C. any combination comprising

Physics, Chemistry and Mathematics (PCM) or Physics. Chemistry and Biology (PCB) or

Physics, chemistry, mathematics and Biology (PCMB).

3. Candidates who have passed D.Pharm course with not less than 50% aggregate, from an

institution, approved by Pharmacy Council of India shall be eligible to this course and shall be

admitted directly to II B. Pharm course.

Duration of the course

The course of study for B.Pharm shall extend over a period of four academic years and three

academic years for those admitted to second B. Pharm directly. The curricula and syllabi for the course

shall be prescribed from time to time.

Medium of Instruction and Examinations

Medium of Instruction and Examination shall be English.

Working days in the academic year

Each academic year shall consist of not less than 200 working days.

2

Attendance and Progress

A candidate is required to put in at least 80% attendance in theory and practical subjects separately.

The candidate shall complete the prescribed course satisfactorily to be eligible to appear for the respective

examinations.

Course of study

The course of study for B.Pharm I, II, III and IV year shall include the respective Theory & Practical

subjects as given in Table - I, II, III and IV respectively. The number of hours to be devoted to each

theory and practical subject in an academic year shall not be less than that shown in Table - I, II, III and

IV.

Academic Work

A regular record of attendance both in Theory and Practical shall be maintained by the teaching staff

of respective subjects.

Internal Assessment Marks:

Theory: Three sessional examinations evenly spread during the academic year shall be conducted by the

constituent colleges. The average marks of the best two examinations shall be computed out of a

maximum of 30 marks and shall constitute the sessional award in theory. Provided further the colleges

may conduct one special theory sessional examination towards the end of the academic session for those

who might have missed any one of the regular sessional examination on genuine grounds.

Practical: Students are expected to perform the experiment listed in the respective syllabus. The number

of experiments is also listed. Marks shall be awarded out of a maximum of 10 to each of the practical

exercise and an average of those shall be computed out of maximum of 10 marks. In addition, three

practical examinations evenly spread during each academic year shall be conducted. The average marks

of the best of two practical examinations shall be computed out of a maximum of 20 marks. A total of 30

marks shall constitute the sessional award in practical. While awarding the sessional marks for practical

experiments, the following considerations should be taken into account.

1. Preparation of the candidate.

2. Manipulative skills.

3. Results of the experiment.

4. Knowledge of the experiment

5. Viva voce pertaining to the experiments only.

The college shall maintain the sessional books of the students and the record of sessional award of

the students. A regular record of both theory and practical class work and sessional examinations

conducted in an institution imparting the course shall be maintained for each student in the institution.

Marks shall be awarded as per the schemes given in Tables - V, VI, VII and VIII.

Conditions under which candidates are permitted to appear for annual university examination

The candidates are required to score a minimum of 50% marks in each of the subjects (Theory and

practicals separately) in the sessional examination to be eligible to appear for annual university

examination in the respective subject.

3

University Examinations

1. Every year there shall be an examination to examine the students.

2. Each examination will be held twice every year. The first examination in a year shall be the annual

examination and the second examination shall be supplementary examination.

3. The examinations shall be of written and practical (including oral nature) carrying maximum

marks for each part of a subject as indicated in Tables - V, VI, VII and VIII.

Question Pattern

Long Essay 2/3 = 2 x 15 = 30 marks

Short Essay 6/8 = 6 x 5 = 30 marks

Short Answers 5/7 = 5 x 2 = 10 marks

-----------------------

Total 70 marks

-----------------------

Criteria for pass

a) Candidates who have secured a minimum of 50% marks in the Theory (including sessionals) and

Practical (including sessionals) separately in any subject or subjects shall be declared to have

passed in that subject/s and exempted from appearing in that subject/s at subsequent examination.

b) Theory and Practical of a particular subject are considered as individual subjects for the purpose of

pass criteria.

c) Those candidates who fail in one or more subjects shall have to appear only in the subject so

failed, in the subsequent examinations.

Conditions under which candidates are permitted to proceed to next higher class:

a) Candidates of I B.Pharm are permitted to carry not more than any two subjects (Two Theory/ Two

Practicals/ One theory & one practical of same or different subjects), to II B. Pharm and appear for

II B.Pharm examination concurrently along with failed subjects of I B.Pharm. However, these

candidates have to pass all the failed subjects of I B.Pharm to become eligible to proceed to III

B.Pharm.

b) Similarly, candidates of II B.Pharm who have completely passed all the subjects of I B.Pharm but

have failed in II B.Pharm are permitted to carry not more than any two subjects (Two Theory/

Two Practicals/ One theory & one practical of same or different subjects), of II B.Pharm to III

B.Pharm and appear for III B.Pharm concurrently along with failed subjects of II B.Pharm.

However, these candidates have to pass all the failed subjects of II B.Pharm to become eligible to

proceed to IV B.Pharm.

c) Candidates of III B.Pharm who have completely passed all the subjects of II B.Pharm but have

failed in III B.Pharm are permitted to carry not more than any two subjects (Two Theory/ Two

Practicals/ One theory & one practical of same or different subjects), to III B.Pharm and appear for

IV B.Pharm examination concurrently along with failed subjects of III B.Pharm and he/she has

satisfactorily completed the project in the IV B. Pharm.

.

4

Declaration of class

Class shall be awarded at the end of I, II, III and final year of B.Pharm examination as shown below:

1) Distinction 75% and above

2) First Class 60% and above and less than 75%

3) Second class 50% and above and less than 60%

The result of the successful candidate shall be classified at the end of the final year examination on the

basis of the aggregate of all subjects, theory and practicals, secured by the candidate in the I to IV year

examinations and completes the course in four years, as indicated below.

I Class : 60% and above

II Class : 50%-59%

Candidate securing aggregate of 75% or above marks and have passed in all the subjects in a year in first

attempt shall be declared to have obtained Distinction.

Project Work

All the students must submit a short report on a project study undertaken in any of the following

subjects:-

i. Pharmaceutics

ii. Pharmaceutical Chemistry

iii. Pharmacognosy

iv. Pharmacology

v. Pharmacy Practice

The project shall be carried out under the guidance of a teacher in the College. The project shall be carried

out either individually or in groups not exceeding 5 in number. The project report shall be submitted in

triplicate (typed copy not exceeding 25 pages).

The project will be evaluated by the examiner at the time of the Practical examination (Final Year)

appointed by the University. The projects shall be evaluated by qualitative grading as Excellent / Good /

Average. The evaluation of the project report shall not be considered for the purpose of pass/class/rank,

but grading shall be included in the Mark Sheet of the Final B. Pharm Course.

Industrial Tour

Candidates studying in final year of the course shall visit several Pharmaceutical manufacturing houses as

a supplement to their academic training and submit a report to the satisfaction of the Head of the

institution where he/she has studied.

Practice School and Industrial training

During III B Pharm and IV B Pharm course, every candidate shall be exposed to Pharmaceutical

Manufacturing operation / research activities for a period of not less than 300 hrs. As a part of this

training, candidates during the III B Pharm course shall be exposed to unit operations in the

college/industry by the industrial experts for a period of 150 hrs and the remaining 150 hrs in

pharmaceutical manufacturing units/ research laboratories during IV B Pharm.

5

Award of Ranks

Ranks and Medals shall be awarded on the basis of aggregate of all the four university examinations.

However, candidates who fail in one or more subjects during the B.Pharm courses shall not be eligible for

award of ranks.

Moreover, the candidates should have completed the B. Pharm course in minimum prescribed number of

years, (four years) for the award of Ranks.

Award of degree

Candidates who fulfill the requirements mentioned above will be eligible for award of degree during the

ensuing convocation.

Duration for completion of the course of study

The duration for the completion of the course shall be fixed as double the actual duration of the course

and the students have to pass within the said period, otherwise they have to get fresh Registration.

Revaluation I Retotalling of answer papers

There is no provision for revaluation of the answer papers of failed candidates in any examination.

However, the failed candidates can apply for retotalling.

Re-admission after break of study

Candidate who seeks re-admission to the course after break of study has to get the approval from the

university by paying a condonation fee.

No condonation is allowed for the candidate who has more than 2 years of break up period and he/she has to rejoin the course by paying the required fees.

6

Courses of study for B. Pharm

Table I: First year B. Pharm

Sl No Subjects Theory

hours / week

Practical

hours / week

1.1 Human Anatomy & Physiology 3 3

1.2 Pharmaceutical Chemistry –I 3 3

1.3 Physical Pharmaceutics 3 3

1.4 Biochemistry 3 3

1.5 Pharmacognosy 3 3

Total number of Working hours 15 15

Grand Total 30 hours

Table II: Second year B. Pharm Sl No Subjects Theory

hours / week

Practical

hours / week

2.1 Pharmaceutics 3 3

2.2 Pharmaceutical Chemistry – II 3 3

2.3 Industrial Pharmacognosy 3 3

2.4 Biostatistics & Computer applications 3 3

2.5 Social Pharmacy and Behavioral Science 3 ---

2.6 Pharmaceutical Jurisprudence 3 ---



7

Table III: Third year B. Pharm


hours / week

Practical

hours / week

3.1 Medicinal Chemistry -I 3 3

3.2 Pharmacology – I 3 3

3.3 Pharmaceutical Engineering 3 3

3.4 Pharmaceutical Biotechnology 3 3

3.5 Pharmaceutical Quality Assurance 3 --

3.6 Biopharmaceutics & Pharmacokinetics 3 --



Table IV: Fourth year B. Pharm


hours / week

Practical

hours / week

4.1 Medicinal Chemistry -II 3 3

4.2 Pharmacology – II 3 3

4.3 Formulative and Industrial Pharmacy 3 3

4.4 Instrumental Methods of Analysis 3 3

4.5 Pharmacy Practice 3 --

4.6 Pharmaceutical Marketing and

Management

3 --



8

Scheme of Study and Examination

Table V: First year B. Pharm course

Sl.

No.

Subject Theory Examination

Total

Marks

Practical Examination

Total

Marks

Sessional Annual Sessional Annual

Duration

(Hrs)

Marks Duration

(Hrs)

Marks Duration

(Hrs)

Marks Duration

(Hrs)

Marks

1.1 Human Anatomy &

Physiology

1.5 30 03 70 100 03 30 04 70 100

1.2 Pharmaceutical Chemistry -I 1.5 30 03 70 100 03 30 04 70 100

1.3 Physical Pharmaceutics 1.5 30 03 70 100 03 30 04 70 100

1.4 Biochemistry 1.5 30 03 70 100 03 30 04 70 100

1.5 Pharmacognosy 1.5 30 03 70 100 03 30 04 70 100

Total 500 500

Grand Total 1000

Table VI: Second year B. Pharm course

Sl.

No.


Total

Marks


Total

Marks


Duration

(Hrs)

Marks Duration

(Hrs)

Marks Duration

(Hrs)

Marks Duration

(Hrs)

Marks

2.1 Pharmaceutics 1.5 30 03 70 100 03 30 04 70 100

2.2 Pharmaceutical Chemistry –

II

1.5 30 03 70 100 03 30 04 70 100

2.3 Industrial Pharmacognosy 1.5 30 03 70 100 03 30 04 70 100

2.4 Biostatistics & Computer

applications

1.5 30 03 70 100 03 30 04 70 100

2.5 Social Pharmacy and

Behavioral Science

1.5 30 03 70 100 No Practical

2.6 Pharmaceutical

Jurisprudence

1.5 30 03 70 100 No Practical

Total 600 400

Grand Total 1000

9

Table VII: Third year B. Pharm course

Sl.

No.


Total

Marks


Total

Marks


Duration

(Hrs)

Marks Duration

(Hrs)

Marks Duration

(Hrs)

Marks Duration

(Hrs)

Marks

3.1 Medicinal Chemistry –I 1.5 30 03 70 100 03 30 04 70 100

3.2 Pharmacology – I 1.5 30 03 70 100 03 30 04 70 100

3.3 Pharmaceutical Engineering 1.5 30 03 70 100 03 30 04 70 100

3.4 Pharmaceutical

Biotechnology

1.5 30 03 70 100 03 30 04 70 100

3.5 Pharmaceutical Quality

Assurance

1.5 30 03 70 100 No Practical

3.6 Biopharmaceutics &

Pharmacokinetics

1.5 30 03 70 100 No Practical

Total 600 400

Grand Total 1000

Table VIII: Fourth year B. Pharm course

Sl.

No.


Total

Marks


Total

Marks


Duration

(Hrs)

Marks Duration

(Hrs)

Marks Duration

(Hrs)

Marks Duration

(Hrs)

Marks

4.1 Medicinal Chemistry –II 1.5 30 03 70 100 03 30 04 70 100

4.2 Pharmacology – II 1.5 30 03 70 100 03 30 04 70 100

4.3 Formulative and Industrial

Pharmacy

1.5 30 03 70 100 03 30 04 70 100

4.4 Instrumental Methods of

Analysis

1.5 30 03 70 100 03 30 04 70 100

4.5 Pharmacy Practice 1.5 30 03 70 100 No Practical


Management

1.5 30 03 70 100

Total 600 400

Grand Total 1000

11

COURSE CONTENTS

First year B. Pharm

Sl.

No. Subjects

Theory

hours / week

Practical

hours / week

1.1 Human Anatomy & Physiology 3 3

1.2 Pharmaceutical Chemistry –I 3 3

1.3 Physical Pharmaceutics 3 3

1.4 Biochemistry 3 3

1.5 Pharmacognosy 3 3



12

1.1 Human Anatomy and Physiology

THEORY 75 Hrs (3Hrs/Week)

Scope: This subject is designed to impart fundamental knowledge on the structure and functions of the

various systems of the human body. It also helps in understanding both homeostatic mechanisms and

homeostatic imbalances of various systems of the body. Since a medicament, which is produced by the

pharmacist, is used in various disease conditions to correct the abnormal functioning of the body systems,

the basic knowledge of this subject is must for a student to understand how drugs act on various

systems/organs in correcting the disease state of organs/systems. Thus it becomes a prerequisite subject

for the pharmacy course.

Objectives: Upon completion of the course the student shall be able to

Understand the gross morphology, structure and functions of various organs of the human body.

Understand the various homeostatic mechanisms and their imbalances.

Identify the various tissues and organs of different systems of human body.

Perform the hematological tests like blood cell counts, haemoglobin estimation, bleeding/clotting

time etc and also record blood pressure, ECG, heart rate, pulse and respiratory volume.

Appreciate coordinated working pattern of different organs of each system

Appreciate the interlinked mechanisms in the maintenance of normal functioning (homeostasis) of

human body.

Lecture wise programme:

Topic Hrs

1. Introduction

Definition, scope of anatomy and physiology, description of body and basic

terminologies.

1

2. General anatomy and physiology

Cell, cell junctions, transport mechanisms, homeostasis, ion channels, cell

communication and signaling pathways.

4

3. Tissues

Definition, classification of tissues, their location, characteristics and Functions.

4

4. Human skeleton

Structure, composition, classification and function of bones. Identification and few

salient features of important bones of axial and appendicular skeleton.

Classification of joints, types of movements.

2

5. Body fluids and blood

Body fluids, composition and functions of blood, haemopoiesis, mechanism of

coagulation, bleeding and clotting disorders, blood grouping and its significance,

blood transfusion, lymphatic system and reticuloendothelial system. Definitions of

Anemia, Hemophilia, leukemia and lymphoma.

7

6. Cardio Vascular system

Anatomy and physiology of heart, blood circulation, cardiac output, cardiac cycle,

heart rate, blood pressure, electrocardiogram, heart sounds. Definitions of

8

13

hypertension, hypotension, atherosclerosis, arteriosclerosis, angina, myocardial

infarction, congestive heart failure, cardiac arrhythmia.

7. Digestive system

Gross anatomy of G.I. Tract and its physiology with special reference to liver,

pancreas and stomach, digestion, absorption, movements of intestine. Definitions

of peptic ulcer, colorectal cancer, hepatitis.

7

8. Respiratory system

Anatomy of respiratory tract, mechanism of respiration, regulation of respiration

lung volumes and capacities, transport of oxygen and carbondioxide, artificial

respiration, resuscitation methods. Definitions of hypoxia, asphysia, bronchial

asthma. COPD.

6

9. Urinary system

Structure and functions of kidney and urinary tract, physiology of urine formation,

micturition reflex and acid base balance. Definitions of renal calculi, urinary tract

infection, nephrotic syndrome, renal failure, nephritis.

4

10. Reproductive system

Structure and function of male and female reproductive system, sex hormones,

physiology and menstruation, coitus, fertilization, spermatogenesis, oogenesis,

pregnancy and parturition.

7

11. Endocrinology

Introduction, chemistry and action of hormones, basic anatomy and physiology of

pituitary, thyroid, parathyroid, adrenal and pancreas, local hormones. Definitions

of disorders of these glands.

7

12. Nervous system

a. Definition and classification nervous system.

b. Neurons and properties of nerve fibers, neuroglia.

c. Synapses, neurotransmitters its receptors and neurohumoral transmission.

d. Meninges, ventricles of the brain and CSF.

e. Anatomy and functions of cerebrum, cerebellum, brain stem (pons,

medulla and mid brain), hypothalamus, thalamus, basal ganglia.

f. Spinal cord- structure and reflexes.

g. Cranial nerves- names and their functions.

h. Definitions of stroke, Alzheimer’s disease, brain tumor, epilepsy,

Parkinson’s disease, psychosis, anxiety, depression.

i. Autonomic nervous system-Anatomy and functions of sympathetic and

parasympathetic nervous system. Definitions of Raynaud’s phenomenon,

autonomic dysreflexia.

11

13. Sense organs

Introduction to special senses. Anatomy and physiology of eye, ear, skin, nose and

tongue. Disorders related to sense organs. Definitions of cataract, glaucoma, sight

disorder, deafness, Otitis media, vertigo.

5

14. Skeletal muscle

Physiology of muscle contraction, definition of myasthenia gravis.

2

14

1.1 Human Anatomy and Physiology (Practical)

Practical: 3 Hrs/week

Title of the experiment Experiments

1. Study of compound microscope. 1

2. Microscopic study of different tissues. 1

3. Identification of bones 1

4. Study of nervous, digestive, respiratory, cardiovascular, urinary, reproductive

systems and special senses with the help of models, charts and specimens.

7

5. Blood experiments:

a. General blood collection techniques

b. Study of appliances used in hematological experiments

c. Determination of total Red Blood Corpuscles (RBC) count

d. Determination of White Blood Corpuscles (WBC) count

e. Determination of platelet count

f. Estimation of hemoglobin

g. Estimation of Differential Leukocyte Count (DLC)

h. Estimation of Erythrocyte Sedimentation Rate (ESR)

i. Determination of Blood groups.

j. Determination of Bleeding and Clotting time

k. Demonstration/Determination of different hematological parameters by

using analytical instruments.

8

6. To record human heart rate, pulse rate and ECG 1

7. To study the effect of posture and exercise on blood pressure 1

8. Recording of human body temperature and Body Mass Index (BMI). 1

9. Determination of tidal volume & vital capacity. 1

10. Study of pregnancy diagnosis test 1

11. Experiments on electrophysiology of nerve and heart using computer assisted

models

2

Recommended Books

1. Essentials of Medical Physiology by K. Sembulingam and P. Sembulingam.

2. Anatomy and Physiology in Health and Illness by Kathleen J.W. Wilson.

3. Physiological basis of Medical Practice-Best and Tailor.

4. Text book of Medical Physiology-Guyton and Hall.

5. Principles of Anatomy and Physiology by Tortora Grabowski.

6. Human Physiology (vol 1 and 2) by Dr. C.C. Chatterrje

7. Textbook of Human Histology by Inderbir Singh

8. Textbook of Practical Physiology by C.L. Ghai

9. Practical workbook of Human Physiology by K. Srinageswari and Rajeev Sharma.

15

1.2 Pharmaceutical Chemistry -I


Scope: This subject consists of two sections. The organic chemistry section deals with classification and

nomenclature of organic compounds, structural isomerism, intermediates forming in reactions, important

physical properties, reactions and methods of preparation of compounds. The syllabus also emphasizes on

mechanisms and orientation of reactions. The analytical chemistry section designed to enable the students

to have fundamental knowledge of volumetric analysis and determination of impurities in

Pharmaceuticals.


write the structure, name, type of isomerism of the organic compound

write the reaction, name the reaction and understand orientation of reactions

account for reactivity/stability of compounds,

identify/confirm the organic compound

know the principle of volumetric analysis of drugs.


Section A: Organic Chemistry 45 hrs

General methods of preparation, General reactions of compounds marked* to be explained.

To emphasize on definition, types/ classification, mechanisms, uses/applications, examples,

differences

Topics Hrs

1 Classification /Nomenclature/ Isomerism

a. Classification of organic Compounds

b. Common and IUPAC systems of Nomenclature of organic compounds

c. Structural Isomerisms in organic compounds

10

2 Alkanes*/Alkenes*/ Conjugated dienes*

a. SP3 hybridization in alkanes, Halogenation of alkanes.

b. i. Stabilities of alkenes, SP2 hybridization in alkenes,

ii. E1 and E2 reactions – kinetics, order of reactivity of alkyl halides,

rearrangement of carbocations, Saytzeffs orientation, evidences. E1

verses E2 reactions, Factors affecting E1 and E2 reactions.

iii. Ozonolysis, electrophilic addition reactions of- alkenes,

Markownikoff’s orientation, free radical addition reactions of alkenes,

Anti Markownikoff’s orientation.

c. Stability of conjugated dienes, Diel-Alder, electrophilic addition, free

radical addition reactions of conjugated dienes, allylic rearrangement

12

3 Cyclo alkanes*

Stabilities – Baeyer’s strain theory, limitation of Baeyer’s strain theory, Coulson

and Moffitt’s modification, Sachse Mohr’s theory (Theory of strainless rings)

3

16

4 Alkyl halides*

a. SN1 and SN

2 reactions-kinetics, order of reactivity of alkyl halides,

stereochemistry and rearrangement of carbocations.SN1

versus SN2

reactions, Factors affecting SN1 and SN

2 reactions

b. Nucleophilic substitution versus elimination reactions

5

5 Alcohols* 3

6 Carbonyl compounds* (Aldehydes and ketones)

Electromeric effect, aldol condensation, crossed aldol condensation, cannizaro

reaction, crossed cannizaro reaction, benzoin condensation, perkin condensation,

Knoevenagel reaction, reformatsky reaction.

6

7 a) Carboxylic acids*

Acidity of carboxylic acids, effect of substituents on acidity, inductive effect

b) Carboxylic acid derivatives*

6

Section B: Analytical Chemistry 30 Hrs

8 Errors:

Sources of errors, types of errors, methods of minimisizing errors, accuracy,

precision and significant figures.

2

9 Impurities:

Source and effect of impurities in pharmacopoeial substances, importance of limit

test, general principle and procedures for limit test, limit test for chloride, sulphate,

Iron, Arsenic, Lead and heavy metals.

6

10 Fundamentals of volumetric analysis:

Theories of Acid-Base indicators and methods of expressing concentrations.

Primary and secondary standard. Preparation and standardization of various

molar/normal solutions like oxalic acid, sodium hydroxide, hydrochloric acid,

sodium thiosulphate, sulpuric acid, potassium permanganate, iodine and ceric

ammonium sulphate solution.

4

11 Acid base titration:

Classification, estimation of strong, weak, very weak Acids and Bases

2

12 Non-aqueous titration:

Introduction, solvents, classification with examples

3

13 Principles of redox titrations:

Concept of oxidation and reduction. Redox reactions, strength and equivalent

weights of oxidizing and reducing agents, theory of redox titrations, cerimetry,

Iodimetry, Iodometry, bromometry.

4

14 Complexometric titrations:

Classification with examples, Metal ion indicator, mechanism.

3

15 Principles of precipitation titrations:

Different methods- Mohr's, Modified Mohr's, Volhard's, Modified Volhard's,

Fajans methods with example.

3

16 Gravimetry: Introduction and steps involved in gravimetric methods of analysis 3

17

1.2 Pharmaceutical Chemistry -I (Practical)



1 Systematic qualitative analysis of unknown organic compound/s for preliminary

tests

1

2 Systematic qualitative analysis of unknown organic compound/s for preliminary

and Lassaigns tests.

2

3 Systematic qualitative analysis of unknown organic compound/s for functional

group (for preliminary / Lassaigns / solubility / functional group tests )

Following classes of compounds may be analysed

Phenols, amide/ urea, carbohydrate, amine, carboxylic acid, aldehyde, ketone,

alcohol, carboxylic acid ester, hydrocarbon, halohydrocarbon, nitrocompound,

anilide

7

4 Determination of melting and boiling points of organic compounds 1

5 Systematic qualitative analysis of unknown organic compound for functional

group and identification of the organic compound

1

6 Preparation of suitable solid derivatives from organic compounds 1

7

Systematic qualitative analysis of unknown organic compound for Functional

group, its identification and confirmation of identification

1

8 Introduction to the use of molecular models

Students to prepare the ball and stick molecular models using lugs , tubes,

plastic sticks, balls etc individually and to explain the formation of bonds , bond

angles, hybridization (example- Methane, Ethane, Ethene, Acetylene, Benzene

etc )

1

9 Limit tests:

Chloride, Sulfate, Iron, Heavy metals and Arsenic

5

10 Assay of the following compounds:

a. Ammonium chloride-acid base titration (Formal titration)

b. Ferrous sulphate- Redox titration- Cerimetry

c. Copper sulphate- Redox titration - Iodometry

d. Calcium gluconate-complexometry

e. Hydrogen peroxide- Redox titration -Permanganometry.

f. Sodium benzoate-nonaqueous titration

g. Sodium chloride-Modified Volhard's method

7

18

Recommended Books

1. Organic Chemistry by Morrison and Boyd

2. Organic Chemistry by I.L. Finar , Volume-I

3. Textbook of Organic Chemistry by B.S. Bahl & Arun Bahl.

4. Organic Chemistry by P.L.Soni

5. A.H.Beckett & J.B. Stenlake's -Practical Pharmaceutical Chemistry Vol I & II, Stahlone Press of

University of London, 4th edition.

6. Text Book of Quantitative Inorganic analysis by Vogel

7. Bentely and Driver's Textbook of Pharmaceutical chemistry

8. Analytical chemistry principles by John H. Kennedy.

9. I.P.1985 ,1996, 2008 Govt. of India, Ministry of Health

10. Practical Organic Chemistry by Mann and Saunders.

11. Vogel’s text book of Practical Organic Chemistry

12. Advanced Practical organic chemistry by N.K.Vishnoi.

13. Introduction to Organic Laboratory techniques by Pavia, Lampman and Kriz.

19

1.3 Physical Pharmaceutics


Scope: The course deals with the various physical, physicochemical properties and principle involved in

formulations of dosage forms. Theory and practical components of the subject help the student to get a

better insight in to various areas of formulation research and development and stability studies of

pharmaceuticals.

Objectives: Upon the completion of the course student shall be able to

Understand various physicochemical properties of drug molecules in the designing the dosage

form

Know the principles of chemical kinetics & to use them in assigning expiry date for formulation

Demonstrate use of physicochemical properties in evaluation of dosage forms.

Appreciate physicochemical properties of drug molecules in formulation research and

development


Topic Hrs

1. Physicochemical properties of drug molecules: Refractive index, optical

rotation, dielectric constant, dipole moment, dissociation constant, determinations

and applications

6

2. Solubility of drugs

Solubility expressions, mechanisms of solute solvent interactions, ideal solubility

& Scatchard-Hildebrand equation, solubility parameters, solvation & association,

quantitative approach to the factors influencing solubility of drugs, Dissolution &

drug release, diffusion principles in biological systems. Solubility of gas in liquids,

solubility of liquids in liquids, (Binary solutions, ideal solutions) Raoult’s law, real

solutions, azeotropic mixtures, fractional distillation. Partially miscible liquids,

Critical solution temperature, and applications

10

3 pH, buffers and Isotonic solutions: Sorensen’s pH scale, pH

determination(electrometric and calorimetric), applications of buffers, buffer

equation, buffer capacity, buffers in pharmaceutical and biological systems,

buffered isotonic solutions

6

3. Surface and interfacial phenomenon

Liquid interface, surface & interfacial tensions, surface free energy, measurement

of surface & interfacial tensions, spreading coefficient, adsorption at liquid

interfaces, surface active agents, HLB classification, solubilisation, detergency

adsorption at solid interface.

6

20

4. Micromeretics

Particle size and distribution, average particle size, number and weight distribution,

particle number, methods for determining particle size, optical microscopy,

sieving, sedimentation measurement, particle shape, specific surface, methods for

determining surface area, permeability, adsorption, derived properties of powders,

porosity, packing arrangement, densities, bulkiness & flow properties.

7

5. Rheology

Newtonian systems, law of flow, kinematic viscosity, effect of temperature on

viscosity, Non-Newtonian systems- plastic, pseudoplastic and dilatants systems.

Thixotropy, thixotropy in formulation, determination of viscosity, capillary, falling

ball, rotational viscometers.

6

6. Drug stability

Reaction kinetics: zero, pseudo-zero, first & second order, units of basic rate

constants, determination of reaction order. Physical and chemical factors

influencing the chemical degradation of pharmaceutical product: temperature,

solvent, ionic strength, dielectric constant, specific & general acid base catalysis,

light. Simple numerical problems.

10

Stabilization of medicinal agents against common reactions like hydrolysis &

oxidation.

Accelerated stability testing in dating of pharmaceutical dosage forms.

7. Colloidal dispersions

Classification of dispersed systems & their general characteristics, size & shapes of

colloidal particles, classification of colloids & comparative account of their general

properties. Optical, kinetic & electrical properties. Effect of electrolytes on

colloids, coacervation, peptization & protective action.

8

8. Coarse dispersion

Suspension, interfacial properties of suspended particles, settling in suspensions,

formulation of suspensions, emulsions and theories of emulsification. Physical

stability of emulsions, preservation of emulsions, rheological properties of

emulsions, phase equilibria and emulsion formulation, special emulsion systems,

semisolids and gels.

10

9. Complexation and protein binding

Metal complexes, organic molecular complexes, inclusion compounds, methods of

analysis, protein binding, complexation and drug action, crystalline structures of

complexes and thermodynamic treatment of stability constants.

6

21

1.3 Physical Pharmaceutics (Practical)


Title of the Experiments Experiments

1. Determination of dissociation and Pka

values. 1

2. Determination of % composition of sodium chloride in the given

unknown solution by CST

1

3. Determination of partition coefficient of iodine distributed between

carbon tetrachloride and water

1

4. Determination of partition coefficient of benzoic acid distributed

between benzene and water

1

5. To determine the solubility of drug at room temperature and express

the solubility in different concentration expressions

1

6. Determination of surface of given liquids by drop count and drop

weight method

1

7. Determination of surface of given liquids by capillary rise method 1

8. Determination of HLB value of ester surfactant by saponification

method

1

9. Determination of critical micellar concentration of surfactants 1

10. Determination of Freundlich and Langmuir’s constants for adsorption

of acetic acid on charcoal.

1

11. Determination of particle size, particle size distribution using

microscopic method.

1

12. Determination of particle size, particle size distribution using sieving

method

1

13. Determination of derived properties of powders like bulk density, true

density and porosity, compressibility of powders.

1

14. To determine the angle of repose and flow rate of granules. 1

15. Determination of viscosity of liquid using ostwalds viscometer 1

16. Determination of viscosity of liquid using falling sphere viscometer 1

17. Determination of half life, rate constant in first order reaction. 1

18. Determination of half life, rate constant in second order reaction(a=b) 1

19. To study the influence of temperature on the rate of reaction. 1

20. To Study of different types of colloids and their properties. 1

21. Preparation of various types of suspensions and determination of their

sedimentation parameters.

1

22. Preparation and stability studies of emulsions. 1

23. To determine the stability constant and donor acceptor ratio by

solubility method.

1

24. To determine the stability constant and donor acceptor ratio by

distribution method.

1

25. To determine the stability constant and donor acceptor ratio by pH

titration method.

1

22

Recommended Books

1. Physical pharmacy by Alfred Martin

2. Experimental pharmaceutics by Eugene, Parott.

3. Tutorial pharmacy by Cooper and Gunn.

4. Stocklosam J. Pharmaceutical calculations, Lea & Febiger, Philadelphia.

5. Liberman H.A, Lachman C., Pharmaceutical Dosage forms, Tablets, Volume-1 to 3, Marcel

Dekkar Inc.

6. Liberman H.A, Lachman C, Pharmaceutical dosage forms – disperse systems, volume 1, 2, 3.

Marcel Dekkar Inc.

7. Laboratory manual of physical pharmaceutics, C.V.S.Subramanyam, J. Thimma setty

23

1.4 Biochemistry


Scope: Biochemistry deals with complete understanding of the molecular levels of the chemical process

associated with living cells. The scope of the present course is providing biochemical facts and the

principles to understand metabolism of nutrient molecules in physiological and pathological conditions,

which can help to understand the mechanism of drug action and fundamental changes occur in diseases.

Objectives:

Upon completion of course student shell able to

Understand the catalytic role of enzymes, importance of enzyme inhibitors in design of new drugs,

therapeutic and diagnostic applications of enzymes.

Understand the metabolism of nutrient molecules in physiological and pathological conditions.

Understand the genetic organization of mammalian genome, functions of DNA and RNA in

protein synthesis.

Understand the principles of organ functions tests and their clinical significances


Topics Hrs

1 Introduction to biochemistry:

a. Cell organelles and its biochemical functions

b. Transport process across the cell membranes

03

2 Bioenergetics:

a. Concept of free energy: determination of free energy from equilibrium constant;

Redox potential.

b. Energy rich compounds; Definition, classification and Production and biological

significance of ATP and cyclic AMP

04

3 Enzymes

a. Definition; Nomenclature; IUB classification

b. Properties of enzymes

c. Factor affecting enzyme activity

d. Enzyme kinetics (Michaelis plot, Line Weaver Burke plot)

e. Enzyme inhibitors with examples

f. Mechanism of enzyme action and theories of enzyme action

g. Allosteric enzymes, Enzyme induction and repression

h. Isoenzymes and their diagnostic applications

i. Therapeutic and diagnostic applications of enzymes

j. Coenzymes –Structure and biochemical role

13

24

4 Biological oxidation

a. Enzymes and co-enzymes involved in Biological oxidation.

b. Electron transport chain (its mechanism and role).

c. Oxidative phosphorylation (its mechanism) and substrate level phosphorylation

d. Inhibitors ETC and Uncouplers or inhibition of oxidative phosphorylation

04

5 Carbohydrate metabolism

a. Definition, classification, chemistry and biological role of carbohydrates

b. Glycolysis – energetics and significance

c. Citric acid cycle- energetics, amphibolic nature, anaplerosis and significance

d. HMP shunt and its significance

e. Glycogen metabolism ( Glycogenolysis and glycogenesis) and its regulation

f. Gluconeogenesis and its significance

g. Various shuttle systems and its significance: glycerol – phosphate & malate - aspertate

h. Uronic acid pathway and its significance

i. Hormonal regulation of carbohydrate metabolism

j. Disorders of Carbohydrate metabolism: Diabetes mellitus, glycogen storage diseases

12

6 Lipid metabolism

a. Definition, classification, chemistry and biological role of lipids

b. β-Oxidation of saturated (Palmitic acid) and unsaturated fatty acids(linolinic acid)

c. Ketone bodies metabolism (Ketogenesis and ketolysis) ketosis and ketoacidosis

d. De novo Biosynthesis of fatty acids (Palmitic acid)

e. Metabolism of cholesterol (Biosynthesis and degradation)

f. Biosynthesis and significance of Phospholipids

g. Disorders of lipid metabolism: Hypercholesterolemia, atherosclerosis and fatty liver

10

7 Amino acid metabolism

a. Definition, classification and biological role of amino acids

b. General reactions of amino acid metabolism: Transamination, deamination &

decarboxylation.

c. Urea cycle and its metabolic disorders

d. Metabolism of sulfur containing amino acids their metabolic disorders

e. Catabolism of tyrosine, tryptophan, phenylalanine and their metabolic disorders

f. Synthesis and significance of biological substances; creatine, histamine, 5-hydroxy

Tryptophan (5-HT), dopamine, noradrenaline, adrenaline

g. Metabolism of Heme and its disorders Porphyriaas, hyperbilirubinemia and jaundice

11

8 Nucleic acid metabolism

a. Definition, chemistry and biological role of nucleosides, nucleotides

b. Biosynthesis of purine and pyrimidine nucleotides

a. Catabolism of purine and pyrimidine nucleotides

b. Disorders of nucleotide metabolism: Gout disease

04

25

9 Replication and Protein synthesis

a. Organization of mammalian genome

b. Structure of DNA and significance as genetic material

e. RNA, structure, types and significance in protein synthesis

f. DNA replication, types and details on semi conservative model

g. Mutation and consequences of mutation

h. DNA Damage and repair mechanism

i. Transcription or RNA synthesis

j. Genetic code

k. Translation or Protein synthesis and its regulation and inhibition

08

10 Clinical biochemistry

a. Role of the kidney: routine performed Laboratory tests (serum creatinine, creatinine

clearance, serum urea and serum uric acid )

b. Liver functions: Metabolic, synthetic, excretion & detoxification. Tests to evaluate the

liver functions

c. Composition and significance of lipoproteins; Lipid profile tests

05

26

1.4 Biochemistry (Practical)

Practical: 3 Hrs/Week

Title of Experiment Experiments

I Qualitative tests for biomolecules

1. Qualitative analysis of carbohydrates

2. Qualitative analysis of Proteins

6

II Liver functions tests

1. Determination of Serum Glutamate Oxoloacetate Transaminase

2. Determination of Serum Glutamate Pyrvuate Transaminase

3. Determination of blood and urine sugar to asses metabolic function

4. Determination of serum calcium

4

II Kidney functions tests

1. Qualitative analysis of urine for normal constituents

2. Qualitative analysis of urine for abnormal constituents

3. Determination of serum total proteins

4. Determination of blood creatine

5. Determination of urine creatinine

6. Determination of blood urea

6

IV Lipid profile tests

1. Determination of serum cholesterol

2. Determination of serum triglycerides

2

V Determination of enzyme activity and study the factors effect of enzyme

activity

1. Determination of Salivary amylase activity

2. Study the effect of pH on salivary amylase activity.

3. Study the effect of Temperature on Salivary amylase activity.

4. Study the effect of substrate concentration on salivary amylase

activity.

4

VI Demo experiment on determination of biochemical parameter in blood

using auto analyzer

1

27

Recommended Books

1. Principles of Biochemistry by Lehninger.

2. Harper’s Biochemistry by Robert K. Murry, Daryl K. Granner and Victor W. Rodwell.

3. Biochemistry by Stryer.

4. Biochemistry by D. Satyanarayan and U.Chakrapani

5. Textbook of Biochemistry by Rama Rao.

6. Textbook of Biochemistry by Deb.

7. Outlines of Biochemistry by Conn and Stumpf

8. Practical Biochemistry by R.C. Gupta and S. Bhargavan.

9. Introduction of Practical Biochemistry by David T. Plummer. (3rd Edition)

10. Practical Biochemistry for Medical students by Rajagopal and Ramakrishna.

11. Practical Biochemistry by Harold Varley.

12. Laboratory manual of Biochemistry by Pattabiraman and Sitaram Acharya

28

1.5 Pharmacognosy


Scope: To learn and understand the cultivation and production of crude drugs and their usefulness.

Objectives: Upon completion of the course, the student shall be able to

Know the advances in the cultivation and production of drugs

Know the evaluation techniques for the herbal drugs.


Topic Hrs

1. Definition, History, present status, future scope & Development of

Pharmacognosy

2

2. Classification of crude drugs: Alphabetical, Morphological, chemical,

taxonomical, pharmacological and chemotaxonomy

5

3. Cultivation, collection, processing & storage of crude drugs

• General principle of cultivation & collection of crude drugs

• Advantages & disadvantages of cultivation.

• Factors influencing cultivation of medicinal plants

• Soil & soil fertility

• Plant hormones & their applications.

• Processing, storage & preservation of crude drugs.

10

4. Quality Control of Crude Drugs: Different method of Adulteration of crude drugs

and their evaluation. Using various methods like Organoleptic, Microscopic,

Physical, Chemical, Biological and Quantitative microscopy

4

5. Conservation of medicinal plants 2

6. Detailed study of the following crude drugs with specific emphasis on source,

cultivation, collection, preparation, storage, diagnostic characters

applicable, constituents, chemical tests, substitutes, adulterants and uses.

a. Carbohydrates: Agar, Gum Acacia, Gum tragacanth, Honey, Isapghol,

Bael

b. Tannins: Black Catechu, Myrobalan, Pale catechu and Arjuna.

c. Lipids: Castor oil, Wool fat, Bees wax, Cod liver oil, Olive oil,

Sesame oil and Chaulmoogra oil

d. Proteins: Gelatin and spirulina

e. Volatile oils: Mentha, Coriander, Cinnamon, Clove, Fennel,Cardamom,

Lemon grass oil, Sandal wood, Lehsun

f. Saponins: Dioscorea, Gokhru, Liquorice, Ginseng, Centella

g. Cardio active sterols: Digitalis, Squill, Stropanthus

h. Anthraquinones: Aloes, Senna, and Rhubarb,

35

29

i. Alkaloids: Areca, Lobelia, Belladonna, Berberis, Datura, Opium,

Ergot, Rauwolfia, Adathoda, Pilocarpus,Kurchi, Punarnava, Sankupusphi,

Ephedra.

j. Resins: Guggul, Garcinia,Balsam of Tolu, Benzoin, Balsum of Peru,

Asafoetida, Turmeric and Ginger, Shellac

7. Tumor inhibitors: Taxol, Vinca and Podophyllum 5

8. Anti hepatotoxic and oral hypoglycemic agents: Phyllanthus, Gymnema 4

9. Plant fibers used as surgical dressings: Cotton, Jute, Flax, silk, wool and rayon.

Sutures – surgical catguts and ligatures.

5

10. Pharmaceutical aids: Talc, Bentonite, Kaolin, Kieselguhr 3

1.5 Pharmacognosy (Practical)

Practical: 3Hrs/Week

Title of Experiments Experiments

1 Microscopical and powder microscopical characters of the following drugs:

Cinchona, Cinnamon, Senna, Digitalis, Rauwolfia, Liquorice, Ipecac,Clove,

Ephedra, Kurchi, Fennel and Coriander

12

2 Study of Morphology of drugs:

Strophanthus, Squill, Rhubarb, Cascara, Liquorice, Senna, Cinchona, Ipecac,

Rauwolfia, Nuxvomica, Vinca, Aconite, Kurchi, Ephedra, Fennel, clove

5

3 Analysis of crude drugs by chemical tests:

i) Asafoetida (ii) Benzoin (iii) Acacia (iv)Agar (v) Gelatin (vi) Aloes vii) Honey

vii)Shark liver oil viii) Castor oil

5

4 Distillation of volatile oils 1

5 Determination of foaming index 1

6 Determination of moisture content of crude drugs 1

Recommended Books

1. Pharmacognosy: V.E.Tyler. Lynn. R. Brady, James E. Robgers.

2. Text book of Pharmacognosy by T.E.Wallis.

3. Study of crude drugs by Iyenger.

4. Powder crude drugs by Iyenger

5. Chemistry of organic natural products vol. I and II by O.P. Agarwal.

6. Practical pharmaceutical chemistry by Backett and Stanlake

7. Indian herbal pharmacopoeia and British herbal pharmacopoeia

8. Anatomy of crude drugs by M.A. Iyengar

9. Text book of Pharmacognosy –Ed.3-C.K. Kokate.

10. Pharmacognosy Pharmacobiotechnology- James Bobbers, Marilyn K, Speedice & V E.Tylor.

30

Second year B. Pharm

Sl.

No. Subjects

Theory

hours / week

Practical

hours / week

2.1 Pharmaceutics 3 3

2.2 Pharmaceutical Chemistry – II 3 3

2.3 Industrial Pharmacognosy 3 3

2.4 Biostatistics & Computer applications 3 3

2.5 Social and Behavioral Science 3 --

2.6 Pharmaceutical Jurisprudence 3 --



31

2.1 Pharmaceutics


Scope: This course is designed to impart a fundamental knowledge on the art and science of formulating

different dosage forms. It prepares the students for most basics of the applied field of pharmacy.

Objectives: Upon the completion of the course the student should be able to:

Know the formulation aspects of different dosage forms

Do different pharmaceutical calculation involved in formulation

Formulate different types of dosage forms

Appreciate the importance of good formulation for effectiveness


Topic Hrs

1 Historical back ground and development of profession of pharmacy

History of profession of Pharmacy in India in relation to pharmacy education,

industry and organization, Pharmacy as a career, Pharmacopoeias: Introduction to

IP, BP, USP and extra pharmacopoeia. Salient features of Indian Pharmacopoeia.

05

2 Dosage forms

Introduction to dosage forms, classification and definitions

Prescription: Definition, significance, parts and handling of Prescription.

Posology: Definition, Factors affecting dose selection. Calculation of doses for

infants & children based on age, body weight and body surface area.

05

3 Pharmaceutical Calculations: Weights and measures – Imperial & Metric

system, Calculations involving percentage solutions, alligation, proof spirit and

isotonic solutions.

06

4 Powders and Granules: Definition, classification, advantages and disadvantages,

Particle size analysis, Flow characteristics, quality control tests, simple &

compound powders – official preparations, insufflations, dusting powders, eutectic

mixtures, effervescent powders and effervescent granules.

Granules: definition, methods of granulation (wet, dry, spray drying, RMG, roller

compaction, high shear mixer granulators), granulation process validation, scaleup

considerations (dissolution testing requirement; size, equipment and process

change; reporting requirements), regulatory issues in granulation processes,

Pellets: Definition; rationale for pelletization; manufacturing considerations-

equipments and methods used (coating pan, FBP, extrusion spheronisation);

formulation variables.

04

04

04

5 Liquid Dosage forms: Classification, Advantages & Disadvantages. General

formulation aspects including adjuvants like Vehicles, Organoleptic additives &

Stabilizers.

02

32

Monophasic Dosage forms:

Study of Monophasic liquids - Definition, formulation and official examples of

gargles, mouthwashes, Throat paint, Eardrops, Nasal drops, Liniments and lotions,

Enemas, collodions, Syrups, Elixirs and solutions.

Biphasic dosage forms:

Suspensions: Definition; advantages and disadvantages; classification; Diffusible

and indiffusible suspensions; Formulation & official examples; Flocculated and

Deflocculated suspension; Surfactants employed (anionic, non-ionic, cat ionic and

additional surfactants); nano suspensions; reconstitutional suspensions; parenteral

suspensions; aerosol suspensions; rheology of suspensions and emulsions.

Emulsions: Definition, classification, test for the identification of type of

emulsion, emulsifying agents, Methods of preparation & stability problems –

cracking, creaming and phase inversion; self emulsifying drug delivery systems;

emulsions for ocular delivery of drugs, multiple emulsions.

03

06

06

6 Semisolid dosage form: Definition, types, mechanism and factors affecting drug

penetration, General formulation of ointments, creams, pastes and gels, their

evaluation and packing, ophthalmic ointments and gels; in situ gels

05

7 Suppositories: Definition, types, advantages and disadvantages, types of bases,

method of preparation, Displacement value & its calculations, packaging and

evaluation.

05

8 Extraction: Definition, study of different extraction processes - Expression,

Infusion, Decoction, Maceration, Percolation & Soxhelation. Examples of tinctures

and extracts.

06

9. Surgical aids

Surgical dressings, sutures, ligatures and preparation of surgical catgut.

04

10 Incompatibilities: Definition, Physical, Chemical and Therapeutic

incompatibilities, reasons and correction of incompatibilities.

04

11. Introduction to novel dosage forms and drug delivery technologies

Ocular drug delivery, transdermal drug delivery, nasopulmonary drug delivery,

colon specific drug delivery, bioadhesive and mucoadhesive systems,

gastroretentive systems, microspheres, microparticles, iontophoresis, osmotic

pumps, oral inhalations, IUD’s, ophthalmic inserts, liposomes, implants,

autoinjection systems

06

33

2.1 Pharmaceutics (Practical)

Practical: 3Hrs/week

Title of the Experiments No of classes

1. Syrups

a) Simple syrup

b) Chlorpheniramine maleate syrup

2

2. Elixirs

a) Piperazine citrate elixir

b) Paracetamol paediatric elixir

2

3. Solutions

a) Strong solution of ammonium acetate

b) Cresol with soap solution

2

4. Suspensions

a) Calamine lotion

b) Magnesium hydroxide mixture

2

5. Emulsions

a) Castor oil emulsion

b) Liquid paraffin emulsion

2

6. Powders and Granules

a) Eutectic powder

b) Effervescent granules

c) Granule preparation-Wet granulation

d) Granule preparation-dry granulation

e) Pellets preparation-extruder spherinizer/ FBP

5

7. Suppositories

a) Boric acid suppository

1

8. Semisolids

a) Sulphur ointment

b) Cold cream

c) Vanishing cream

d) Bentonite Gel

e) In situ gel preparation

5

9. Gargles and Mouth Washes

a) Potassium chlorate gargle

b) Any antiseptic mouth washes

2

10. Tinctures

a) Orange tincture

b) Compound Benzoin tincture

2

34

Recommended Books

1. H.C. Ansel et al, Pharmaceutical Dosage form and Drug delivery system, Lippincott Williams and

Walkins, New Delhi, 7th Edition, 2000.

2. Carter S.J., Cooper and Gunn’s-Dispensing for Pharmaceutical students, CBS publishers, New

Delhi 12th Edition. 2000.

3. M.E. Aulton, Pharmaceutics, The Science& Dosage Form Design, Churchill Livingstone,

Edinburgh, 2nd Edition, 2002.

4. Indian pharmacopoeia and British pharmacopoeia.

5. Theory and practice of Industrial pharmacy by Lachmann.

6. Alfonso R. Gennaro Remington: The science and practice of pharmacy, Vol I and Vol II,

Lipponcott Williams, 20th edition, 2000.

7. Carter S.J., Cooper and Gunn’s-Tutorial pharmacy, CBS Publications, New Delhi, 6th edition,

2000.

8. E.A. Rawlins, Bentley’s text book of Pharmaceutics, English language Book Society, 8th edition,

1997.

9. Isaac Ghebre Sellassie: Pharmaceutical; Pelletization Technology, Marcel Dekker, INC, New

York, 1989.

10. Dilip M. Parikh: Handbook of Pharmaceutical Granulation Technology, Marcel Dekker, INC,

New York, 1997.

11. Francoise Nieloud and Gilberte Marti-Mestres: Pharmaceutical Emulsions and Suspensions,

Marcel Dekker, INC, New York, 2000.

35

2.2 Pharmaceutical Chemistry - II


Scope: The subject deals with structure, stability and reactivity of organic compounds. It emphasizes on

mechanisms and orientation of reactions. The syllabus includes physical properties of organic compounds

and named reactions. This course also deals with stereo chemical aspects of organic compounds and

stereo chemical reactions.


write the structure, name, the type of isomerism of the organic compound

write the reaction, name the reaction and understand orientation of reactions

understand the stereo chemical aspects of organic compounds and reactions

know and account for stability/reactivity/orientation


Topics Hrs

Note: To emphasize on definition, types/ classification, mechanisms, examples, uses/ applications,

differences.

1 Benzene and its derivatives

a. Analytical/ synthetic/ other evidences in the derivation of structure of benzene.

Orbital picture, resonance in benzene, aromatic characters, Huckel’s rule

Reactions of benzene – nitration, sulphonation, halogenation- reactivity, friedel crafts

alkylation- reactivity, limitations, friedel crafts acylation.

Substituents,effect of substituents on reactivity and orientation of mono substituted

benzene compounds towards electrophilic substitution reactions.

b. Aryl halides

Nomenclature,General methods of preparation, General reactions of - Aryl

halides,Nucleophilic aromatic substitution reactions (Bimolecular nucleophilic

substitution and Benzyne- mechanisms), effect of substituents on reactivity towards

nucleophilic aromatic substitution reactions

c. Phenols - Nomenclature,General methods of preparation, General reactions, Acidity

of - phenols, effect of substituents on acidity

d. Amines

Nomenclature,General methods of preparation, General reactions,

Basicity of - aromatic amines, effect of substituents on basicity, comparision

with aliphatic saturated amines, synthetic uses of diazonium salts

18

2 Polynuclear hydrocarbons:

Synthesis , reactions and medicinal uses of of following compounds/ derivatives -

Naphthalene, Phenanthrene, Anthracene. Diphenylmethane and Triphenylmethane.

8

3 Reactions of synthetic importance

a. Catalytic hydrogenation, metal hydride reduction, Clemmensen reduction, Meerwein

Pondorff Verley reduction, Birch reduction, Wolff kishner reduction.

8

36

b. Oppenauer-oxidation, Dakin reaction.

c. Beckmanns rearrangement, Schmidt rearrangement.

d. Claisen-Schmidt Condensation

4 Stereo isomerism:

a. Optical isomerism –

i. Optical activity, enantiomerism, diastereoisomerism, meso

compounds

ii. Elements of symmetry, chiral, achiral- molecules

iii. DL system of nomenclature of optical isomers,

sequence rules,

RS system of nomenclature of optical isomers

iv. Reactions of chiral molecules

v. Racemic modification, resolution of racemic mixture.

vi. Asymmetric synthesis- partial, absolute

b. Geometrical isomerism

i. Nomenclature of geometrical isomers (Cis Trans, EZ, Syn Anti systems)

ii. Methods of determination of configuration of geometrical isomers.

c. Conformational isomerism –in alkanes, Cyclopentane, Cyclohexane.

d. Stereo isomerism in biphenyl compounds (Atropisomerism) - conditions for optical

activity.

e. Stereospecific and stereoselective reactions

18

5 Heterocyclic compounds:

a. Nomenclature.

b. Synthesis ,reactions and medicinal uses of following compounds /derivatives

i. Pyrrole/Furan/Thiophene - Relative aromaticity, reactivity, Basicity of pyrrole,

ii. Pyrazole/ Imidazole/ Oxazole/ Thiazole.

iii. Pyridine/ Quinoline/ Isoquinoline/ Acridine/ Indole. Basicity of pyridine

c. Synthesis and medicinal uses of following compounds / derivatives - Pyrimidine/

Purine.

15

6 Fats and Oils.

a. Fatty acids- Reactions

b. Hydrolysis, hydrogenation, saponification and rancidity- of oils, drying oils.

c. Analytical constants – Acid value, saponification value, ester value, iodine value,

acetyl value, Reichert Meissl (RM) value –significance and principle involved in the

determination.

8

37

Pharmaceutical Chemistry –II (Practical)

Practical: 3 Hours/Week


I Quantitative determination of following classes of organic compounds

( including standardization of reagents)

1. Alcohol by acetylation method.

2. Carbonyl compound by hydroxyl amine hydro chloride method.

3. Carboxylic acid by acid base method.

4. Ester by hydrolysis method.

5. Amino acid by formal titration method

6. Aldehyde by sodium sulfite sulphuric acid method.

7. Acetone by Sodium hypo iodite method.

8. Phenol by bromination method.

( Students to carry out Minimum of seven Quantitative

determination experiments)

7

II Determination of following oil values (including standardization of

reagents)

1. Acid value.

2. Saponification value.

3. Iodine value by pyridine bromide method.

4. Iodine value by iodine mono chloride method.

( Students to carry out Minimum of three determination of oil value

experiments)

3

III Preparation of homocyclic compounds. ( Students to prepare

Minimum of six homocyclic compounds listed below )

1. Benzanilide/Phenyl benzoate/Acetanilide from Aniline/ Phenol

/Aniline by acylation reaction.

2. 2,4,6-Tribromo aniline/Para bromo acetanilide from Aniline/

Acetanilide by halogenation (Bromination) reaction.

3. 5-Nitro salicylic acid/Meta di nitro benzene from Salicylic acid /

Nitro benzene by nitration reaction.

4. Benzoic acid from benzyl chloride by oxidation reaction.

5. Benzoic acid/Salicylic acid from alkyl benzoate/ alkyl salicylate

by hydrolysis reaction.

6. 1- Phenyl azo -2- napthol from aniline by diazotization and

coupling reactions.

6

38

IV

Preparation of heterocyclic compounds. (Students to prepare

Minimum of Five heterocyclic compounds listed below or any other

heterocyclic compounds)

1. Benzimidazole from ortho phenylene diamine.

2. 2,3–diphenyl quinoxaline from benzil

3. Benzotriazole from ortho phenylene diamine by diazotization.

4. 2-phenyl indole from acetophenone.

5. 3-methyl 1-phenyl pyrazol-5-one from ethylacetoacetate

5

V Separation of binary mixture of organic compounds 2

VI Stereo modeling of enantiomers, diastereoisomers, anomers, epimers

meso compounds, geometrical isomers, conformational isomers (chair,

boat, twist conformers of cyclohexane and substituted cyclohexane),

biphenyl compounds etc.

2

Recommended Books

1. Organic chemistry by I. L. Finar, Volume-I & II.

2. A text book of organic chemistry – Arun Bahl , B.S.Bahl.

3. Heterocyclic Chemistry by Raj K. Bansal

4. Organic Chemistry by Morrison and Boyd

5. Heterocyclic Chemistry by T.L.Gilchrist

6. Elementary Practical Organic Chemistry by AI Vogel, Part- III, Quantitative Organic

Analysis.

7. Practical Organic Chemistry by Mann and Saunders.

8. Practical Pharmaceutical Chemistry, Volume- I & II by Beckett and J. B.Stanlake

9. Indian Pharmacopoeia

10. Vogel’s text book of Practical Organic Chemistry

11. Advanced Practical Organic Chemistry by N. K. Vishnoi

39

2.3 Industrial Pharmacognosy


Scope: To learn and understand the techniques involved in the herbal drug, cosmetic preparation and their

standardization

Objectives: Upon completion of the course, the student shall be able to

know the modern extraction techniques, characterization and identification of the herbal drugs

understand the preparation and development of herbal drugs as per GMP guidelines


Topics Hrs

1 Modern methods of extraction, application of latest techniques like

Spectroscopy, chromatography and electrophoresis in the isolation, purification

and identification of crude drugs.

11

2 a) Introduction to plant biochemistry with special reference to basic metabolic

pathways.

b) Introduction to biogenesis of secondary metabolites like Atropine,

Ergotamine, Morphine and Steroidal glycosides.

c) Study of utilization of radioactive isotopes in the investigation of

Biogenetic studies.

08

3 A brief account of plant based industries and institutions involved in work on

medicinal and aromatic plants in India.

02

4 Industrial production and estimation of the following phytoconstituents:

Forskolin, Sennoside, Artemisinin, Diosgenin,, Tropane alkaloids.,

Curcumin,Rutin, Phyllanthin, Asiaticoside, Andrographolides and Gymnemic

acid

10

5 Herbal formulation development and standardization

a) Preparation, stability testing of Herbal extracts and formulations

b) Role of Herbs in Cosmetics

Hair care preparation - Henna, Amla, Hibiscus

Skin Care preparation – Aloe vera, Turmeric, Sandal wood

c) Neutraceuticals

10

6 WHO Guidelines for the assessment of Herbal Medicine and Cosmetics 02

7 a) Basic principles involved in the alternative system of medicine viz.

Ayurveda, Siddha, Unani and Homeopathy

b) Preparation and standardization of Ayurvedic formulations i.e.

Aristas, Asawas, Ghutika,Churna, Leha and Bhasma.

07

8 Plant Toxins and adverse drug reactions:

Natural allergens, Hallucinogens, Teratogens.

06

9 Plant tissue culture:

Historical development, nutritional requirements, growth and their

maintenance, applications of plant tissue culture and types of cultures related to

cell suspension culture, callus culture, hairy root culture and protoplast culture

07

40

10 Enzyme Biotechnology

Introduction, general methods of isolation, purification and application of

immobilized enzymes.

Biological sources, methods of preparation, chemical nature and uses of:

a. Papain b. Pepsin c. Trypsin d. Pancreatin e. Asparaginase, urokinase

07

11 a) Herb-Drug interaction

b) Edible Vaccine

02

2.3: Industrial Pharmacognosy (Practical)



1 Exercise involving isolation of active principles

a. Caffeine - from tea dust.

b. Curcumin from turmeric

c. Berberine from Berberis

d. Andrographolide from Kalmegh

e. Diosgenin from Dioscorea

f. Phyllanthin from Phyllanthus neruri

g. Piperine from Pepper

h. Hespiridin from orange peel

08

2 Separation of amino acids by Paper chromatography 1

3 TLC analysis of extracts 1

4 Determination of

a. Moisture content (Loss on drying)

b. Extractive values

c. Ash values

d. Swelling factors

4

5 Preparation and standardization of Ayurvedic formulations 1

6 Preparation of herbal cosmetics 1

7 Demonstration of experiments in column chromatography 1

8 Demonstration of experiments in plant tissue culture. 1

Recommended Books

1. Pharmacognosy by Trease and Evans 14th and 15th edition.

2. Pharmacognosy Pharmacobiotechnology- James Bobbers, Marilyn K, Speedice & V.E. Tylor.

3. Herbal Drug Industry R.D.Chowdary.

4. The formulation and preparation of cosmetic, fragrances and flavours.

5. Remington’s Pharmaceutical sciences.

6. WHO Guidelines – website http:/www/who.int/druginformation

7. Standardization of botanicals.

8. Quality Control Herbal Drugs - Pulok K.Mukherjee.

9. Pharmacognosy and Phytochemistry I edition, vol- l &II by Vinod. D. Rangari

10. Practical Pharmacognosy, III edition, C.K. Kokate.

41

2.4 Biostatistics and Computer applications


Scope: This subject deals with the introduction to computers, M.S. Word, M.S. Excel, Computer

graphics, operating system, softwares, Net-work, Internet, Computer application in clinical studies.

Biostatistics deals with the Frequency distribution, Graphics, Measures of central tendency, Correlation,

Regression, Probability theory, Sampling technique, Sample, Parameter, Statistics, Students t-test and

Pharmaceutical examples.


know the operation of M.S. Word, M.S. Excel, M.S. Access

know the various application of computers in pharmacy

know the various statistical technique to solve statistical problems

solve statistical problems by using Excel

appreciate various applications of software packages in Pharmacy

Appreciate statistical techniques in solving the problems.


Topics Hrs

Section A: Biostatistics

01 Frequency distribution: Definition, Types of frequency distribution,

Cumulative frequency

Graphical Representation: Histogram, frequency polygon, frequency curve,

Semi logarithmic graph, ogive.

06

02 Measures of central tendency : Average, Types of averages - Mean, Median,

Mode, Harmonic mean, Geometric mean, Quartile, deciles, percentile -

Pharmaceutical examples

08

03 Measures of dispersion : Dispersion, Range, quartile deviation, mean

deviation, standard deviation, Variance, coefficient of variation, application

of coefficient of variation in pharmacy, skewness, Kurtosis, coefficient of

skewness, Pharmaceutical problems

08

04 Correlation : Definition, Types of correlation, Karl Pearson’s coefficient of

correlation, Rank difference method, Correction of tied ranks, Multiple

correlation - Pharmaceuticals examples

05

05 Regression: Curve fitting by the method of least squares, fitting the lines y= a

+ bx and x = a + by, fitting the curve y = abx , fitting exponential curve,

Multiple regression, standard error of regression, difference between

regression and correlation – Pharmaceutical Examples

05

06 Probability : Trial, event, sure event, random event, Sample space, Definition

of probability, mutually exclusive events, Independent event, Law’s of

Probability - simple problems, Binomial distribution, Normal distribution,

Poisson’s distribution, properties - problems

06

42

07 Sample, Population, large sample, small sample, Null hypothesis, alternative

hypothesis, sampling, essence of sampling, types of sampling, Error-I type,

Error-II type, Standard error of mean (SEM) - Pharmaceutical examples

05

08 T- distribution : t-test between the means of Population and sample, Pooled

t-test, student’s t-test, Pharmaceutical examples

04

Section B: Computer Science

09 Number system: Binary number system, Decimal number system, Octal

number system, conversion decimal to binary, binary to decimal, octal to

binary etc, binary addition, binary subtraction – First complement, second

complement method, binary multiplication, binary division

05

10 Over view of computers, Generation of computers, Types of computers –

Mini, Micro, Super computer, digital, analog and hybrid computers, input

devices, output devices, input/output devices – Floppy disk, CD-ROM, Pen

drive, Monitor, Printers, types of printers-Impact and Non impact printers,

08

11 Algorithm and flow chart – Pharmaceutical problems 02

12 Hardware, software , types of software’s – System, application, Custom

software

02

13 Operating system, Types of Operating systems 02

14 Computer Network – LAN, WAN, MAN, Internet, Intranet, WWW 02

15 Programming languages – Machine language, Assembly language, High level

languages

01

16 Introduction to M.S. Office – M.S. Excel, M.S. Access-operators and

Expression

03

17 Application of computers in Pharmacy – Drug information storage and

retrieval, Pharmacokinetics, Drug design, Crude drug identification, Hospital

and Clinical Pharmacy, Pharmaceutical analysis

03

43

2.4: Biostatistics and Computer applications (Practical)



1. Introduction to M.S. Word, Mail Merge, Table Handling 2

2. Introduction to Excel - Graphs – Histogram, Bar, Line, Pie etc 1

3. Introduction to mathematical functions and Statistical functions - Sum,

Average, Exponential, Logarithm, Round, Power , If and Else - logical

function

2

4. Calculation of Averages using excel - Mean - Individual, discrete and

continuous series

1

5. Calculation of Median and Mode using Excel - Discrete and continuous

series

1

6. Calculation of Geometric mean, Harmonic mean using Excel -

Individual, Discrete and continuous series

1

7. Calculation of mean deviation by direct and shortcut method using

Excel - Individual, Discrete and continuous series

1

8. Calculation of Standard deviation and coefficient of variation by direct

method using Excel - Individual, Discrete and continuous series

1

9. Calculation of Standard deviation and Coefficient of variation by

shortcut method using Excel - Individual, Discrete and continuous

series

1

10. Calculation of coefficient of correlation by direct , shortcut method and

Rank difference method using Excel

1

11. Multiple correlation problem 1

12. Calculation of coefficient of Skewness using Excel 1

13. Calculation of Kurtosis using excel 1

14. Formation of linear regression equation – calculation of predicted values 1

15. Binomial distribution , Poisson’s distribution problems – Using excel 1

16. t-test Problem to know the significance difference between population

and sample mean – Using excel

1

17. Pooled t-test Problem to know the significance difference between

means of two Samples – Using excel

1

18. Student’s t-test Problem to know the significance difference between

means of Control and treatment group – Using excel

1

19. Student t-test from correlation coefficient and regression coefficient 1

20. Introduction to Access - Creating database, Creating table, designing

table – creating forms

1

21. Writing programme to generate labels of different formulation using

access

1

22. Operating statistical software 1

23. Introduction to Power point – Slides Preparations 1

44

Books Recommended

1. Pharmaceutical Statistics - By Sanford Bolton – Third/Fourth Edition

2. Comdex Computer Course Kit - Vikas Guptha

3. Fundamental of Statistics - S.C.Guptha

4. Practical Problems in Statistics – D.N.Elhance and Veen Elhance

5. Microsoft Office Access – 2003 - Cary N.Prague, Michael R.Irwin

6. Statistics - Kapoor

7. Fundamental of Statistics - S.N.Guptha

8. Methods in Biostatistics – B.K.Mahajan

45

2.5. Social Pharmacy and Behavioral Science


Scope: Social Pharmacy and Behavioral Science course will prepare the young pharmacy student to fit

into the social role as Pharmacist. Interaction of pharmacist with doctors, nurses, dentists, physiotherapists

and other health workers is to develop team spirit in pharmacist. Rational drug use and essential drugs

concepts can be realized with meaningful interaction of pharmacists with other health care providers. At

the end of this course the student will get the soft skills set to work cohesively with the team as a team

player and will add value to the pharmaceutical business.

Objectives:

Upon completion of the course the student shall be able to

Understand the behavioral needs for a Pharmacist to function effectively in the areas of

pharmaceutical Operation

Communicate effectively ( Verbal and Non Verbal)

Effectively Manage the team as a team player

Manage the time effectively

Develop Leadership Qualities and Essentials

Topics Hrs

1. Social Pharmacy and Behavioral Science

The Concept and context of social pharmacy

02

2. Pharmacy Profession

a) Introduction to profession of Pharmacy

b) Pattern of entry and employment in pharmacy

c) Employment position and job responsibilities of a pharmacist

d) Role of pharmacist in health care

e) Pharmacy ethics

10

3. Professionalization of community pharmacy

a) Introduction – professional status of community pharmacy

b) Patients medication records and pharmacist’s extended role

c) Health screening services in community pharmacy

08

4. Role of hospital pharmacist in a hospital

a) Introduction

b) Manufacturing, purchasing, inventory management, distribution and

promoting the rational view of medicine

c) Definition and concept of clinical pharmacy

15

5. Time Management

a) Value of Time

b) How to Track the action items

c) Goal setting

d) Using SMART Objective concept

e) Goals, Tasks, Sub Tasks

f) Resource Management

g) Mile Stone, Mapping and Gantt chart application

10

46

6. Preparing for an Interview

a) Creating an Effective CV (Objective Setting, Skills, how to prepare the

content, Describing Self, Summarizing the Education and Self, Selling

your Experience, Deciding on looks, Getting it Right)

b) Define the purpose of the interview

c) Preparation of STP, PDCA

d) Improving the delegation

e) Dress Code and Code of Conduct

f) Do’s and Don’ts

g) Style of communication

h) Attitude Vs Skills

i) Confidence Vs arrogance

10

7. Motivations 12

Analyzing Motivation

a) Definition of Motivation

b) Understanding Behavior

c) Recognizing the Needs

d) Human Brain and Human Psychology

Building UP

a) Assessment of Attitude

b) Being Good for Many

c) Improving Communication

d) Creating No Blame Culture

e) Winning Cooperation

f) Encouraging Initiatives

Getting the Best from People

a) Motivating People

b) Motivating Self

c) Group Motivation

d) Dealing with De-motivated Individuals

e) Apprising Effectively

f) Evaluating each Jobs

g) Encouraging the staff

h) Empowering the staff

i) Building the Career

j) Rewarding achievement

k) Recognizing Excellence

l) Moving To change

m) Rewarding Exceptional Performance

n) Keeping motivation high

o) Tool for finding out how good an individual is a motivator

47

Communications Skills:

a) Oral and written communications

b) Electronic communication

c) Discussions and meetings outcome as a communication

d) Presentation and Group discussion

e) Postures during the presentation or one to one meeting

f) Appraisals of staff by a Manager

g) Meetings Vs Structured meetings

h) Components of Meetings and Meeting Outcome

i) Communication skills in pharmacy practice

Text Books

1. Social Pharmacy – Innovation & development – Harding Jeoffrey, Pharmaceutical Press,

London (1994).

Reference Books

1. Use of Essential Drugs- WHO expert committee 1997.

2. Estimating drug requirement –practical manual- WHO, Geneva.

3. Public education in rational drug use- WHO, Geneva.

4. Inspired, Organized & Effective! by Darrin Salle (Feb 8, 2012).

5. Creating Successful CV - Simon Howard

6. How to Delegate – Robert Heller, DK Publication

7. Appraising Staff – Ken Langdon, Christina Osborne

8. Motivating People – Robert Heller

9. 18 Minutes: Find Your Focus, Master Distraction and Get the Right Things Done

10. Senn Delaney Leadership and Team

11. Say Goodbye to Chaos - Organize Your Life: This Ultimate Guide of Organizing Tips will

Teach You How to Get Organized and How to Stay Organized [Kindle Edition] Edward V.

Lewis, BlueSheepBooks

12. Steven Coveys - 8th Habit

13. The Seven habits of Highly Effective People by Stephen Covey

14. Communicating: A Social and Career Focus - Andrew D. Wolvin

15. Interpersonal Communication: Everyday Encounters (Wadsworth Series in Communication

Studies)

16. The 80-20 Principle by Richard Koch

17. Mind Gym

18. The One Minute Manager Meets: The Monkey by Ken Blanchard

http://www.amazon.com/Inspired-Organized-Effective-ebook/dp/B0077E3Q5I/ref=sr_1_5?s=books&ie=UTF8&qid=1334220674&sr=1-5

http://www.amazon.com/s/ref=ntt_athr_dp_sr_2?_encoding=UTF8&search-alias=digital-text&field-author=Edward%20V.%20Lewis

http://www.amazon.com/s/ref=ntt_athr_dp_sr_2?_encoding=UTF8&search-alias=digital-text&field-author=Edward%20V.%20Lewis

http://www.amazon.com/s/ref=ntt_athr_dp_sr_1?_encoding=UTF8&search-alias=digital-text&field-author=BlueSheepBooks

http://www.amazon.com/s/ref=ntt_athr_dp_sr_1?_encoding=UTF8&sort=relevancerank&search-alias=books&ie=UTF8&field-author=Andrew%20D.%20Wolvin

48

2.6: Pharmaceutical Jurisprudence


Scope: The subject deals with several important legislations related to the profession of pharmacy in

India. The Drugs and Cosmetics Act, along with its amendments is the core of this course. Other acts,

which are covered, include the Pharmacy Act, dangerous drugs, medicinal and toilet preparation Act etc.

Besides this the new drug policy, professional ethics, DPCO, patent and design Act will be discussed

Objectives: At the end of the course, the student shell able to

Know and understand the Pharmaceutical legislations and their implications in the development

and marketing

Understand and follow the code of ethics during the pharmaceutical practice

Know and understand various Indian pharmaceutical acts and laws

Know about the process of drug discovery and developments

Know the regulatory authorities and agencies governing the manufacture and sale of

pharmaceuticals

Know the regulatory approval process and their registration in Indian and international markets


Topics Hrs

1. Definition and scope of Forensic Pharmacy 1

2. Pharmaceutical Legislation-A brief review

Introduction, Study of drugs enquiry committee, Health survey and development

committee, Hathi committee and Mudaliar committee

2

3. Code of Pharmaceutical ethics

Definition, Pharmacist in relation to his job, trade, medical profession and his

profession, Pharmacist’s oath.

2

4. Pharmacy act-1948 & new Amendments

Objectives, Definitions, Pharmacy Council of India; its constitution and

functions, Education Regulations, State and Joint state pharmacy councils,

Registration of Pharmacists, Offences and Penalties.

3

5. Drugs and cosmetics act 1940 and rules 1945 & New Amendments

Objectives, Definitions, Legal definitions of schedules to the act and rules

Import of drugs – Classes of drugs and cosmetics prohibited from import, Import

under license or permit.

Manufacture of drugs – Prohibition of manufacture and sale of certain drugs,

Conditions for grant of license and conditions of license for manufacture of

drugs, Manufacture of drugs for test, examination and analysis, manufacture of

new drug, loan license and repacking license. Detailed study of schedule M, N

and Y.

Sale of Drugs – Wholesale, Retail sale and Restricted license.

Labeling & Packing of drugs- General labeling requirements and specimen labels

12

49

for drugs and cosmetics, List of permitted colors.

Administration of the act and rules – Drugs Technical Advisory Board, Central

drugs Laboratory, Drugs Consultative Committee, Government analysts,

Licensing authorities, controlling authorities, Drug Inspectors

6. Medicinal and Toilet preparations (Excise Duties) Act 1955

Objectives, Definitions, Licensing, Manufacture In bond and Outside bond,

Export of alcoholic preparations, Offences and Penalties.

3

7. Narcotic drugs and psychotropic substance act 1985 and rules

Objectives, Definitions, Authorities and Officers, Prohibition, Control and

Regulation, opium poppy cultivation and Production of poppy straw,

manufacture, sale and export of opium, Offences and Penalties.

3

8. Drugs and Magic remedies (Objectionable Advertisement) act 1955

Objectives, Definitions, Prohibition of certain advertisements, Classes of

Exempted advertisements, Offences and Penalties.

2

9. Pharmaceutical Policy 2002 and its amendments

Objectives, Approaches in the review, Salient features

2

10. Prevention of cruelty to Animals act-1960

Objectives, Definitions, Institutional Animal Ethics Committee, Breeding and

Stocking of Animals, Performance of Experiments, Transfer and Acquisition of

animals for experiment, Records, Power to suspend or revoke registration,

Offences and Penalties.

2

11. Drugs (price control) order-1995 & New Amendments

Objectives, Definitions, Sale prices of bulk drugs, Retail price of formulations,

Retail price and ceiling price of scheduled formulations, Implementation of prices

Fixed/ revised.

2

12. Sales promotion employees (Conditions of service) Act 1

Regulatory affairs

13. New Drug Discovery and development

Stages of drug discovery, Drug development process, pre-clinical studies, non-

clinical activities, clinical studies, Concept of generics, Generic drug product

development.

8

14. Regulatory authorities and agencies

Overview of regulatory authorities of United States, Australia, United Kingdom.

International Conference on Harmonization, World Health Organization.

12

15. Regulatory Approval Process

Investigational New Drug (IND), New Drug Application (NDA), Abbreviated

New Drug Application (ANDA). Changes to an approved NDA / ANDA.

10

16. Registration of drug product in overseas market

Procedure for export of pharmaceutical products, Technical documentation,

Common Technical Document (CTD), electronic Common Technical Document

(eCTD)

10

50

Recommended books

1. Forensic Pharmacy by B. Suresh

2. Text book of Forensic Pharmacy by B.M. Mithal

3. Hand book of drug law-by M.L. Mehra

4. A text book of Forensic Pharmacy by N.K. Jain

5. Drugs and Cosmetics Act/Rules by Govt. of India publications.

6. Medicinal and Toilet preparations act 1955 by Govt. of India publications.

7. Narcotic drugs and psychotropic substances act by Govt. of India publications

8. Drugs and Magic Remedies act by Govt. of India publications.

9. Drug Regulatory Affairs by Sachin Itkar, Dr. N.S. Vyawahare, Nirali Prakashan.

10. The Pharmaceutical Regulatory Process, Second Edition Edited by Ira R. Berry and Robert P.

Martin, Drugs and the Pharmaceutical Sciences,Vol.185. Informa Health care Publishers.

11. New Drug Approval Process: Accelerating Global Registrations By Richard A Guarino, MD, 5th

edition, Drugs and the Pharmaceutical Sciences,Vol.190.

12. Guidebook for drug regulatory submissions / Sandy Weinberg. By John Wiley & Sons. Inc.

13. FDA Regulatory Affairs: a guide for prescription drugs, medical devices, and biologics /edited by

Douglas J. Pisano, David Mantus.

51

Third year B. Pharm

Sl.

No. Subjects

Theory

hours / week

Practical

hours / week

3.1 Medicinal Chemistry –I 3 3

3.2 Pharmacology – I 3 3

3.3 Pharmaceutical Engineering 3 3

3.4 Pharmaceutical Biotechnology 3 3

3.5 Pharmaceutical Quality Assurance 3 ---

3.6 Biopharmaceutics & Pharmacokinetics 3 ---



52

3.1 Medicinal Chemistry – I


Scope: This subject is designed to impart fundamental knowledge on the structure, chemistry and

therapeutic value of drugs. The subject emphasizes on structure activity relationships of drugs, importance

of physicochemical properties and metabolism of drugs. The syllabus also emphasis on chemical

synthesis of important drugs under each class.


understand the chemistry of drugs with respect to their pharmacological activity.

understand the drug metabolic pathways, adverse effect and therapeutic value of drugs.

know the Structural Activity Relationship of different class of drugs.

write the chemical synthesis of some drugs


Topics Hrs

I. Introduction to Medicinal Chemistry 12

A. History and development of medicinal chemistry 01

B. Physicochemical properties in relation to biological action

Ionization, Solubility, Partition Coefficient, hydrogen bonding, protein

binding, chelation, Bioisosterism, optical and geometrical isomerism

05

C. Drug metabolism

General pathways of drug metabolism (different types of reaction in phase-I

and phase-II with examples)

Factors affecting drug metabolism including stereochemical aspects

06

II. Drugs acting on Autonomic Nervous System 22

A. Adrenergic Neurotransmitters:

Biosynthesis and catabolism of catecholamine

Adrenergic receptors system (Alpha & Beta) and their distribution

02

B. Sympathomimetic agents: SAR of Sympathomimetic agents

Direct acting: Nor-epinephrine, Epinephrine, Phenylephrine*, Dopamine,

Methyldopa, Clonidine*, Dobutamine, Isoproterenol, Terbutaline,

Salmeterol, Salbutamol*, Bitolterol, Albuterol, Ritodrine, Naphazoline,

Tetrahydrozoline, Oxymetazoline and Xylometazoline

Indirect acting agents: Hydroxyamphetamine, Pseudoephedrine,

Propylhexedrine

Agents with mixed mechanism: Ephedrine*, Metaraminol

04

C. Adrenergic Antagonists:

Alpha adrenergic blockers: Tolazoline*, Phentolamine*,

Phenoxybenzamine, Prazosin, Tetrazosin, Doxazosin, Ergotamine,

Methysergide

03

53

Beta adrenergic blockers: SAR of beta blockers, Propranolol*,

Dichloroisoproterenol, Practolol, Metibranolol, Acebutolol, Atenolol,

Betazolol, Bisoprolol, Esmolol, Metoprolol, Labetolol and Carvedilol

D. Cholinergic neurotransmitters

Biosynthesis and catabolism of acetylcholine

Cholinergic receptors system (muscaranic & nicotinic) and their

distribution

02

E. Parasympathomimetic agents: SAR of Parasympathomimetic agents

Direct acting agents: Acetylcholine, Carbachol*, Bethanechol,

Methacholine, Pilocarpine

Indirect acting/Cholinesterase inhibitors (Reversible & Irreversible):

Physostigmine, Neostigmine, Pyridostigmine*, Edrophonium chloride,

Tacrine hydrochloride, Ambenonium chloride, Isofluorphate,

Echothiophate iodide, Parathione, Malathion

Cholinesterase reactivators: Pralidoxime chloride

03

F. Cholinergic Blocking agents: SAR of cholinolytic agents

Solanaceous alkaloids and analogues: Atropine sulphate, Hyoscyamine

sulphate, Scopolamine hydrogenbromide, Homatropine hydrogenbromide*,

Ipratropium bromide*.

Synthetic cholinergic blocking agents: Tropicamide, Cyclopentolate

hydrochloride, Clidinium bromide, Dicyclomine hydrochloride*,

Glycopyrrolate, Methantheline bromide, Propantheline bromide,

Benztropine mesylate, Orphenadrine citrate, Biperidine hydrochloride,

Procyclidine hydrochloride*, Tridihexethyl chloride, Isopropamide iodide,

and Ethopropazine hydrochloride

Ganglionic blocking agents: Trimethaphan camsylate, mecamylamine

Neuromuscular blocking agents: Metocurine Iodide, pancuronium

bromide

05

G. Local Anesthetics: SAR of Local anaesthetics

Benzoic Acid derivatives; Cocaine, Hexylcaine, Meprylcaine,

Cyclomethycaine, Piperocaine

Amino Benzoic acid derivatives: Benzocaine*, Butamben, Procaine*,

Butacaine, Propoxycaine, Tetracaine, Benoxinate,

Lidocain/Anilide derivatives: Lignocaine*, Mepivacaine, Prilocaine,

Etidocaine

Miscellaneous: Phenacaine, Diperodon, Dibucaine* and Dyclonine

03

III. Drugs acting on Central Nervous Sysytem 18

A. General anesthetics:

Inhalation anesthetics: Halothane*, Methoxyflurane*, Enflurane,

Sevoflurane, Isoflurane, Desflurane

Ultra short acting barbitutrates: Methohexital sodium*, Thiamylal sodium*,

Thiopental sodium

02

54

Dissociative anesthetics: Ketamine hydrochloride*

B. Sedatives and Hypnotics:

Benzodiazepines: SAR of Benzodiazepines, Chlordiazepoxide*,

Diazepam*, Oxazepam, Chlorazepate Dipotassium, Lorazepam,

Alprazolam, Zolpidem

04

Barbiturtes: SAR of barbiturates, Barbital*, Phenobarbital, Mephobarbital,

Amobarbital, Butabarbital, Pentobarbital, Secobarbital

Miscelleneous:

Amides & imides : Glutethmide

Alcohol & their carbamate derivatives: Meprobomate, Ethchlorvynol

Aldehyde & their derivatives: Triclofos sodium*, Paraldehyde.

C. Skeletal Muscle relaxants : Methocarbamol, Chlorphenesin 01

D. Antipsychotics

Phenothiazeines: SAR of Phenothiazeines - Promazine hydrochloride,

Chlorpromazine hydrochloride*, Triflupromazine, Thioridazine

hydrochloride, Piperacetazine hydrochloride, Mesoridazine hydrochloride, ,

Prochlorperazine maleate*, Trifluoperazine hydrochloride

Chlorprothixene, Thiothixene, Loxapine succinate, Clozapine

Fluro buterophenones: Haloperidol, Droperidol, Risperidone

Beta amino ketones: MolindoneHcl

Benzamides: Sulpieride

03

E. Anticonvulsants: SAR of Anticonvulsants, mechanism of anticonvulsant

action

Hydentoins: Phenytoin*, Mephenytoin, Ethotoin

Oxazolidine diones: Trimethadione*, Paramethadione

Succinimides: Phensuximide, Methsuximide, Ethosuximide*

Urea and monoacylureas: Phenacemide, Carbamazepine*

Benzodiazepines: Clonazepam

Miscellaneous: Primidone, Valproic acid* , Gabapentin, Felbamate

04

F. CNS stimulants

Analeptics- Nikethamide*, Doxapram hydrochloride, Pentylenetetrazole,

Caffeine, Theophylline, Theobromine

Psycomotor stimulants- Amphetamine, Dextroamphetamine sulphate*,

Methamphetamine, Chorphentermine, Chlortermine, Phendimetrazine,

Methylphenidate, Pemoline

MAO inhibitors- Phenelzine sulphate, Isocarboxazid, Tranylcypromine,

Pargyline hydrochloride

Tricyclic anti-depressants - Amitriptyline hydrochloride*, Nortryptyline,

Imipramine hydrochloride*, Desipramine hydrochloride, Trimipramine

maleate, Doxepin hydrochloride, Amoxapine, Fluoxetine.

04

55

IV. Drugs acting on Cardiovascular System 23

A. Anti-anginal:

Vasodilators: Amyl nitrite, Nitroglycerin*, Pentaerythritol tetranitrate,

Isosorbide dinitrite*, Dipyridamole

Calcium channel blockers: Verapamil, Bepridil hydrochloride, Diltiazem

hydrochloride, Nifedipine, Amlodipine, Felodipine, Nicardipine,

Nimodipone

03

B. Cardiotonics: Digoxin, Digitoxin, Deslanoside 01

C. Anti-arrythmic Drugs: Quinidine sulphate, Procainamide hydrochloride,

Disopyramide phosphate*, Phenytoin sodium, Lidocaine hydrochloride,

Tocainide hydrochloride Mexiletine hydrochloride, Lorcainide hydrochloride,

amiodarone and Sotalol.

03

D. Anti-hypertensive Agents: timolol, Captopril, Lisinopril, Enalapril,

Benazepril hydrochloride, Quinapril hydrochloride, Methyldopate

hydrochloride,* Clonidine hydrochloride, Guanethidine monosulphate*,

Guanabenz acetate, Sodium nitroprusside, Diazoxide, Minoxidil, Reserpine,

Hydralazine hydrochloride

03

E. Diuretics:

Carbonic anhydrase inhibitors: Acetazolamide*, Methazolamide,

Dichlorphenamide.

Thiazides: Chlorthiazide*, Hydrochlorothiazide*, Hydroflumethiazide,

Cyclothiazide,

Loop diuretics: Furosemide*, Bumetanide, Ethacrynic acid.

Potassium sparing Diuretics: Spironolactone, Triamterene, Amiloride*

Miscelleneous: Mannitol, and Theophylline

04

F. Anti-hyperlipidemic agents: Clofibrate, lovastatin, cholesteramine and

cholestipol

01

G. Coagulant & Anticoagulants: menodione, acetomenadione, Warferin*,

phenindione

01

H. Oral hypoglycemic agents: tolbutamide, metformin, glipizide, pioglitazone,

acarabose

01

I. Thyroid & Antithyriid: L-Thyroxine, L-Thyronine, Propylthiouracil,

Methimazole.

01

J. Drugs acting on GIT:

Antacids, antiulcers, laxatives and anti-diarrhoeal agents, emetics &

antiemetics

05

56

3.1: Medicinal Chemistry – I (Practical)


Title of the experiments Experiments

1. Preparation of medicinally important compounds or intermediates

required for synthesis of drugs

1. Phenothiazine from Diphenylamine

2. Phenytoin from Benzil

3. Benzocaine from PABA.

4. Afalanine from phenyl alanine

5. Dibenzal acetone from benzaldehyde by Claison Schmidt

6. 2,4,5 Triphenyl imidazole from Benzoin,

7. Cinnamic acid from Perkin’s reaction.

8. Aryloxy acetic acid from phenols

9. p-iodo benzoic acid from PABA

10. Dimethyl amino propiophenone from acetophenone

11. Warfarin from 4-hydroxy coumarin

12. Chlorzoxazone from 2-Amino, 5-chloro Phenol

13. 1,4 - Napthoquinone from naphthalene

14. 7-Hydroxy, 4-methyl coumarin from resorcinol

12

2. Monograph analysis of selected drugs from course content

1. Phenobarbitone

2. Caffine

3. Theophylline

4. Frusemide

4

3. Assay of Selected drugs from course content prescribed as per I.P or

B.P.

1. Assay of Ibuprofen by alkalimetry

2. Assay of Aspirin by alkalimetry

3. Assay of Diclofenac by alkalimetry

4. Assay of Analgin by Iodimetry

5. Assay of Paracetamol by Iodimetry

6. Assay of Phenobarbitone by non aqueous titrimetry

7. Assay of Chlorpromazine by cerrimetry

8. Assay of Atropin by alkalimetry

9. Assay of Frusemide by alkalimetry

10. Assay of Chlorpheniramine by non aqueous titrimetry

09

57

Recommended Books

1. Wilson and Giswold’s Organic medicinal and Pharmaceutical Chemistry, 11th edition.

2. Foye’s Principles of Medicinal Chemistry, 5th edition.

3. Burger’s Medicinal Chemistry, Vol I to IV.

4. Introduction to principles of drug design- Smith and Williams.

5. Remington’s Pharmaceutical Sciences, 20th edition.

6. Martindale’s extra pharmacopoeia.

7. Organic Chemistry by I.L. Finar, Vol. II.

8. The Organic Chemistry of Drug Synthesis by Lednicer, Vol. 1-5.

9. Indian Pharmacopoeia 1996 and 2007 editions.

10. Text book of practical organic chemistry- A.I.Vogel, 5th edtion.

58

3.2 Pharmacology – I (Theory)


Scope: The main purpose of the subject is to understand what drugs do to the living organisms and how

their effects can be applied to therapeutics. The subject covers the complete information about the drugs

like sources, physico chemical properties, mechanism of action, physiological and biochemical effects

(pharmacodynamics) as well as absorption, distribution, metabolism and excretion (pharmacokinetics)

along with the adverse effects, clinical uses, interactions, doses, contraindications and routes of

administration of different classes of drugs.

Objectives: Upon completion of the subject student shall be able to

explain the pharmacological actions of different categories of drugs on various systems of the

body.

explain the mechanism of drug action at organ system/sub cellular/ macromolecular levels.

apply the basic pharmacological knowledge in the prevention and treatment of various diseases.

handle the animals and conduct the experiments to observe the effect of drugs from different

therapeutic classes and to interpret the results using suitable statistical analysis.

appreciate correlation of pharmacology with other bio medical sciences


Topics Hrs

1. General Pharmacology

a. Introduction to Pharmacology- Definition and various branches of

pharmacology.

b. Pharmacodynamics- Principles and mechanisms of drug action. Classification

of receptors, Signal transduction mechanisms of ligand gated ion channels, G

Protein–coupled receptors, Kinase linked receptors and receptors that regulate

transcription factors. Drug receptors interactions, combined effects of drugs and

factors modifying drug action.

c. Pharmacokinetics- Detail study of various factors influencing drug absorption,

distribution, metabolism and excretion.

d. Pharmacogenetics.

e. Adverse drug reactions.

f. Discovery and development of new drugs-Preclinical and clinical studies.

20

2. Pharmacology of Peripheral Nervous System

a. Organization and function of ANS.

b. Neurohumoral transmission.

c. Parasympathomimetics, Parasympatholytics, Sympathomimetics and

Sympatholytics.

d. Neuromuscular blocking agents and skeletal muscle relaxants (peripheral).

12

59

e. Local anesthetic agents.

f. Drugs used in Myasthenia Gravis.

3. Pharmacology of Central Nervous System

a. Neurohumoral transmission in the C.N.S with special emphasis on

Pharmacology of various neurotransmitters like histamine, serotonin, dopamine,

GABA, Glutamate and Glycine.

b. General anesthetics.

c. Alcohol and disulfiram.

d. Sedatives, hypnotics and centrally acting muscle relaxants.

e. Psychopharmacological agents: Antipsychotics, antidepressants, antianxiety

agents, anti-manics and hallucinogens.

f. Anti-epileptic drugs.

g. Drugs used in Parkinsonism and Alzheimer’s disease.

h. Narcotic analgesics and antagonists.

i. C.N.S stimulants and Nootropics.

j. Drug addiction, drug abuse, tolerance and dependence.

21

4. Pharmacology of Cardiovascular System

a. Introduction to haemodynamics and Electrophysiology of heart.

b. Anti-hypertensive drugs.

c. Anti-anginal drugs.

d. Anti-arrhythmic drugs.

e. Drugs used in congestive heart failure.

f. Anti-hyperlipidemic drugs.

g. Haematinics, anticoagulants and haemostatic agents.

h. Fibrinolytics and antiplatelet drugs.

i. Blood and plasma volume expanders.

16

5. Drugs acting on Urinary System

Diuretics and anti-diuretics.

3

6. Drugs acting on Respiratory System

a. Anti-asthmatic drugs.

b. Anti-tussives and expectorants.

c. Respiratory stimulants.

d. Mucolytics and nasal decongestants.

3

60

3.2 Pharmacology I (Practical)


Title of experiments Experiments

1. a. Commonly used Apparatus/instruments in experimental pharmacology.

b. Commonly used laboratory animals and their handling

c. Maintenance of laboratory animals, regulations of animal use and Ethical

requirements according to CPCSEA

d. Some common laboratory techniques: Blood withdrawal, plasma and serum

separation,

e. anesthetics used for animal studies, procedures for rendering animal

unconscious and chemical euthanasia

6

2. Study of different routes of drugs administration in mice/rats 2

3. To study the effect of hepatic microsomal enzyme inhibitors and inducers on the

Phenobarbitone sleeping time in mice.

2

4. Experiments on Central nervous system: Recording of spontaneous motor activity,

stereotype activity, anti-catatonic activity, analgesic activity, anticonvulsant

activity, anti-inflammatory activity and skeletal muscle relaxant activity of drugs

7

5. Local anesthetic activity of drugs by suitable animal model 1

6. Effect of autonomic drugs on rabbit’s eye 1

7. Experiments based on computer models like Expharm 1

8. Diuretic activity of drugs in rats 1

9. Statistical calculations in experimental pharmacology

a. Students-t-test, b. ANOVA

1

Recommended Books

1. Essentials of Medical Pharmacology by K.D.Tripathi.

2. Pharmacology and Pharmacotherpeutics by Satoskar R.S and Bhandarkar S.D.

3. Lippincott’s illustrated Reviews- Pharmacology by Mycek M.J, Gelnet S.B and Perper M.M.

4. Hand book of Experimental Pharmacology by Kulkarni.S.K.

5. Fundamentals of Experimental Pharmacology by M. N. Ghosh.

6. Pharmacology by Rang. M.P. Dale, M.M, Reter J.M.

7. Goodman and Gilman’s, The Pharmacological basis of therapeutics by Gillman G, Rall T.W.,Nies

A.I.S., and Taylor P.

8. Basic & Clinical Pharmacology by Katzung B.G.

61

3.3 Pharmaceutical Engineering


Scope: This course is designed to impart a fundamental knowledge on the art and science of various

machines and their handling in pharmaceutical industry. This course focuses on various topics like unit

operations, material handling, pharma plant construction, corrosion, industrial pollution etc.

Objectives: Upon completion of the course student shall be able

1. to know various unit operations used in Pharmaceutical Industries.

2. to understand the material handling techniques.

3. to perform various processes involved in pharmaceutical manufacturing process.

4. to carry out various tests to prevent environmental pollution.

5. to appreciate and comprehend significance of plant lay out design for optimum use of resources.

6. to appreciate the various preventive methods used for corrosion control in Pharmaceutical

Industries


Topic Hrs

1. Unit Operations and Processes

Introduction to industrial processing unit operations and processes. Fundamental

concept of material and energy balance, Dimensional analysis.

2

2. Size Reduction

Definition, objectives of size reduction, factors affecting size reduction. Mechanism

of size reduction, Laws governing size reduction. Types of mills and operations of

Hammer mill, Ball mill, Fluid energy mill, Edge runner mill & End runner mill.

Criteria for selection of equipment.

4

3. Size Separation

Standards Sieves, IP grade powder. Different modes of size separation, Types of

screening equipments, Sieves, Sieve shaker, sedimentation tanks, cyclone separator,

elutriation tank, Air separator, Bag filter and particle size distribution.

4

4. Mixing

Theory of mixing, factors influencing selection of mixers. Solid-solid, solid-liquid

and liquid-liquid mixing equipments used in pharmaceutical industry- V-Cone,

Ribbon and Double cone blender, Sigma blade and planetary mixers, Propellers,

Turbines, Paddles, Baffles, ultrasonic mixers and homogenizers.

5

5. Filtration

Theory of filtration, filter aids, filters medias. Factors affecting rate of filtration.

Types of industrial filters and their operation such as filter press, filter leaf, rotary

drum filter, Meta filter, Candle filter.

3

6. Centrifugation

Principles of centrifugation, Study of laboratory and large scale centrifuges and their

application.

2

62

7. Crystallization

Crystal forms and crystal habit, solubility curves, Mier’s super saturation theory of

Crystallization, nucleation and crystal growth. Classification, principle under- lying

the design and operation of tank crystallizer, Swenson Walker Crystallizer. Vacuum

type crystallizers, caking of crystals and its prevention.

6

8. Evaporation

Basic concept of phase equilibrium. Factors affecting evaporation. Types of

evaporators and its study Heat and material balances, single and multiple effect

evaporators.

4

9. Distillation

General theory applied to binary mixtures, boiling point and equilibrium diagrams

and Raoults law. Constant boiling mixtures (Azeotropes). Rectification, construction

of rectifying columns. Simple distillation, Steam distillation, Flash distillation,

Molecular distillation and Extractive distillation and its applications.

6

10. Drying

Introduction, theory of drying, rate of drying, Moisture content. Classification of

dryers including Vacuum, tray, Spray and fluidized bed dryers. Principle of freeze-

drying and freeze dryers.

5

11. Refrigeration

General considerations, coefficient of performance, refrigeration cycle. Choices of

refrigerate, application in pharmacy. Compressor design and its application in

Pharma Industries.

2

12. Pharmaceutical manufacturing environment Design

Definition of various terms, psychometric charts, wet bulb temperature. Adiabatic

saturation temperature, determination of humidity, methods of increasing and

decreasing humidity, importance of humidity and its control. Principles of Air

conditioning and air conditioners and their application in pharmacy. HVAC system

and Air Classification as per ISO, US and EU standards, airflow pattern in

pharmaceutical industry, Use of LAF in sterile parenteral dosage forms, air velocity,

and CFM calculation.

4

13. Plant location

Layout, utilities and services.

2

14. Industrial hazards and safety measures

Mechanical, chemical, electrical, fire and explosive hazards in pharmaceutical

process, including inflammable gases and dusts explosion. Safety measures in

pharmaceutical plants.

5

15. Corrosion and its prevention

General considerations, Classification & theories of corrosion, detail study of

different types of corrosion, Factors affecting, prevention & control of corrosion.

3

63

16. Materials of pharmaceutical Plant construction

Factors affecting the material selection for Pharmaceutical plants. Classification,

Physical, Chemical and mechanical properties and uses of important materials and

their alloys employed in the construction of pharmaceutical plants.

4

17. Flow of fluids

Fluid Mechanics, types of manometers, Reynolds number and its significance.

Distribution of velocities across a pipe, Boundary layers, Bernoulli’s theorem and its

applications, Orifice meter, Venturimeter, Pitot tube and Rotometer. Fluid heads,

Energy losses, measurement of flow of fluids. Pumps, study of different types of

pumps.

6

18. Heat transfer

Heat transfer mechanisms. Heat transfer by conduction. Fourier’s law, compound

resistance in series, heat flow through a cylinder. Natural and forced convection,

convection through fluids. Surface coefficients, overall heat transfer coefficients.

Radiation, Concepts of black and grey body, Heat interchangers, heat exchangers.

Types of Boilers and steam generators, Pure Steam Generation and its quality

determination.

6

19. Material handling & packaging systems

Introduction, different types of conveyors like belt, screw, pneumatic conveyors.

Product contact Parts, accessories along with container closures

2

64

3.3 Pharmaceutical Engineering (Practical)



1. Drying of wet granules and to plot the rate of drying curves. 3

2. Operation of sieve shaker and sieve analysis and deriving various

statistical parameters. 2

3. Viscosity determination by Stoke’s law. 2

4. Rate of filtration studies, factors affecting filtration. 3

5. Determination of extraction efficiency by single and multiple extractions. 2

6. Mixing: Determination of mixing efficiency when propeller blade is

introduced in different positions. 1

7. Methods of crystallization, study of crystal habit. 2

8. Steam distillation: collection of volatile oil (Demonstration). 1

9. Evaporation: factors affecting the rate of evaporation. 3

10. Determination of uniformity index using double cone blender. 2

11. To determine the leaching of contents from packaging material:

Ampoules. 1

12. Demonstration experiments on equipments viz. colloid mill, planetary

mixer, spray dryer, freeze dryer. 3

Recommended Books

1. Introduction to chemical engineering – Walter L Badger & Julius Banchero, Latest edition

2. Unit operation of chemical engineering –Mcabe Smith, Latest edition,

3. Pharmaceutical Engineering principles and practices – C.V.S.Subrahmanyam et al. , Latest edition

4. Physical Pharmacy-Martin et al., Latest edition

5. Bentleys Pharmaceutics—Davis, Latest edition

6. Physical Pharmaceutics—Shotton, Latest edition

7. Remington Practice of Pharmacy—Martin, Latest edition

8. Cooper and Gunn’s Tutorial Pharmacy, S.J. Carter., Latest edition

9. Theory and practice of Industrial Pharmacy by Lachman., Latest edition

10. Refrigeration and Air conditioning by L. Ballaney., Latest edition.

65

3.4 Pharmaceutical Biotechnology (Theory)


Scope: This paper has been designed to provide the advanced knowledge to the Pharmacy students in

valuable areas of advanced Biotechnology which plays a crucial role in determining its future use and

applications in medicine, drug discovery and in pharmaceutical industry. It also emphasize the study of

microbiological and biotechnological processes, its modern technology aspects to useful products and to

correct the alternative ways to prevent the occurrence and the treatment of disease related to

microorganisms and techniques

Objectives: Upon completion of the subject student shall be able to

understand methods of identification, cultivation and preservation of various microorganisms

understand Genetic engineering applications in relation to production of pharmaceuticals

know the importance of immunological reactions and preparations of immunological products.

do sterilization of various equipments/products and bacterial sensitivity testing against antibiotics

and disinfectants.

appreciate the use of microorganisms in fermentation technology


Topics Hrs

1. Microbiology

a. Introduction to Microbiology: Scope of Microbiology, Microbes of Medicinal

interest, study of mode of Transmission & treatment of Microbial diseases

like Cholera, Typhoid, Tuberculosis, Diphtheria, Tetanus, Syphilis & AIDS.

b. Classification, Morphology and fine structure Bacteria, Fungi, Viruses.

c. Methods of isolation and identification of bacteria - staining techniques and

bio chemical reactions. Total & viable counting techniques of bacteria

d. Growth and cultivation, Their Nutritional requirements.

e. Media-differential, enriched, selective. Maintenance of lab culture

20

2. Sterilization

a. Detail study of different methods of sterilization including their merits and

demerits.

b. Detailed study of sterility testing of different pharmaceutical preparations.

c. Disinfectant: study of disinfectant. Factors affecting their action and

evaluation of bactericidal & Bacteriostatic.

d. Principles and methods of different microbiological assays including

sensitivity testing with references to ciprofloxacin, streptomycin & vitamin

B12.

07

3. Microbial Genetics

a. Genetic organization of Eukaryotes and Prokaryotes

b. Microbial genetics including transformation, transduction, conjugation,

plasmids and transposons.

07

66

c. Introduction to Microbial biotransformation, Biotransformation of steroids

and production of single cell protein.

4. Molecular Biology and Engineering

a. Study of cloning vectors, restricted endonucleases and DNA ligase.

b. Application of r DNA technology and genetic engineering in the products:

a) Interferon b) Vaccines- hepatitis- B c) Hormones- Insulin.

05

5. Introduction to bioinformatics

a. Access to Molecular Biology Data Bases: Nucleic Acid Sequences,

Genomes, Protein Sequence and Structures, Entrez, Sequence Retrieval

System (SRS), Protein Identification Resource (PIR).

b. Sequence Alignment, Software’s (BLAST, FASTA, CLUSTAL-W),

Construction of Phylogenetic Tree.

c. Protein Structure Prediction, Applications of Bioinformatics.

05

6. Bio process technology

a. Introduction to fermentation technology, study, design and operation of

fermenter.

b. Bioprocess of the following metabolites: Alcohol, Citric acid, Penicillin,

Griseofulvin, Vitamin B12, and Glutamic acid.

04

7. Enzyme biotechnology

a. Introduction, classification and uses.

b. Techniques of immobilization.

c. Application, biosensors and their application.

d. Production of amylase, Catalase, peroxidase, lipase, Protease Streptokinase,

penicillinase

05

8. Immunology and Immune Biotechnology

a. Introduction, types of Immunity, antigen and haptens, antigen- antibody

reactions, complementary systems, structure and function of MHC, antigen

recognition and presentation, hypersensitivity, Hypersensitivity response,

immuno stimulation and suppression and Auto immune disorders.

b. Immunization – Definition, types, preparation, standardization and

application of official vaccines, containerization, storage conditions and

stability of official vaccines.

c. Hybridoma technology: Introduction, Techniques of production and

purification of monoclonal antibodies. Application of monoclonal antibodies.

d. Immuno blotting techniques such ELISA, Western Blot, Southern Blot

20

9. Animal Biotechnology :Introduction to animal tissue culture, characters, general

procedure for the maintenance of cell culture, Nutritional requirements, Primary

and established cell culture and application of animal tissue culture.

02

67

3.4 Pharmaceutical Biotechnology (Practical)



1. Microbiology

a. Study of apparatus used in experimental microbiology.

b. Sterilization techniques – Glasswares, media, Room.

c. Preparation and sterilization of Media.

d. Isolation techniques– Streak plate, Pour plate, spread plate techniques

e. Staining techniques- Simple staining Gram’s staining, Acid fast staining,

Spore staining, flagella staining, Capsule staining.

f. Total and viable count of Microorganisms.

g. Motility of the microorganism by Hanging drop method.

h. Bacteriological analysis of water by MPN techniques.

i. Sterility testing for Pharmaceutical products.

j. Microbiological assay of antibiotics.

k. Biochemical test (IMViC reactions).

18

2. Bioprocess

a. Production of alcohol and wine by fermentation process.

b. Immobilization techniques – Whole cells, Enzymes

c. Isolation of protein from the microorganism.

d. Estimation of protein by Lowry’s method.

4

3. Biotechnology

a. Isolation of plasmid by electrophoresis.

b. Isolation and estimation of DNA by spectroscopy.

c. Isolation and estimation of RNA by spectroscopy.

3

68

Recommended Books

1. Microbiology by Pelzer, Krieg and Chan.

2. Essential and applications of Microbiology by Judy Kandal.

3. Microbial Genetics by David Freifeider.

4. Microbiology by Prescott.

5. General Microbiology by R.Y. Stainer.

6. Text Book of Microbiology by Ananthanarayan and Paniker.

7. Immunology by Weir

8. Immunology by Ivan Roitt.

9. Microbiology – A laboratory manual by James g. Cappuchino.

10. Laboratory Microbiology by L. Jack Bradshaw.

11. Practical Medical Microbiology – Mackie and McCartney.

12. Pharmaceutical Microbiology by Hugo and Russell.

13. Text Book of Biotechnology by Vyas and Dixit.

14. Text Book of Biotechnology by R.C. Dubey.

15. Principle of Gene Manipulation by S.B. Primrose.

16. Text book of Fermentation technology by Stanbury.

17. Industrial Microbiology by L.E. Casida.

18. Biochemical Engineering by Webb and Steel.

19. Microbial Technology by PepplerVol .I and II.

20. Gene V and VI by Benjamin Lewin.

21. Fogel, G.B. and Corne, D.W., Evolutionary Computation in Bioinformatics

22. Lesk, A.M. 2002 Introduction to Bioinformatics. Oxford University Press

23. Mont, D.W., Bioinformatics: Sequence and Genome Analysis

24. Date, C.J. An Introduction to Database Systems, Vol I & II. Addison Wesley

69

3.5 Pharmaceutical Quality Assurance

THEORY 75 Hrs (3 Hrs/Week)

Scope: This course deals with the various aspects of quality control and quality assurance aspects of

pharmaceutical industries. It covers the important aspects like cGMP, QC tests, documentation, quality

certifications and regulatory affairs.

Objectives: Upon completion of the course student shall be able to

understand the cGMP aspects in a pharmaceutical industry

appreciate the importance of documentation

understand the scope of quality certifications applicable to pharmaceutical industries

understand the responsibilities of QA & QC departments


Topics

Hrs

1. Definition - Quality control and Quality assurance, concept and philosophy of

TQM, GMP, ICH, Brief study of ICH common technical documents – Q1-Q11,

Quality by design, six sigma concept, ISO 9000 & 14000.

08

2. Organization and personnel: Personnel responsibilities, training, hygiene and

personal records.

04

3. Design, construction and plant layout, maintenance, sanitation, environmental

control, utilities and maintenance of sterile areas, control of contamination.

05

4. Equipments and raw materials: Equipments selection, purchase specifications,

maintenance, purchase specifications and maintenance of stores for raw materials.

07

5. Quality control test for containers, closers, caps and secondary packing materials. 06

6. Document maintenance in pharmaceutical industry: Batch Formula Record, Master

Formula Record, SOP, Quality audit, Quality Review and Quality documentation,

Reports and documents, distribution records.

08

7. Complaints and evaluation of complaints, Handling of return good, recalling and

waste disposal.

04

8. Warehousing: Good warehousing practice, materials management. 04

9. Responsibilities of quality control laboratory- GLP, Standard test procedures,

protocols for clinical and non - clinical testing and control on animal houses.

Application of computers in quality control and quality assurance laboratory.

10

10. Calibration and Validation: Introduction and general principles, Calibration and

Validation of analytical equipments, Analytical method Validation.

03

11. NABL certification and licensing and accreditation procedure for drug industry.

Patent regime and intellectual property rights.

08

12. Regulatory affairs: Regulatory aspects in India, US-FDA and European

commissions. GATT policy.

08

70

Recommended Books

1. Quality Assurance Guide by organization of Pharmaceutical Products of India.

2. Good Laboratory Practice Regulations, 2nd

Edition, Sandy Weinberg Vol. 69.

3. Quality Assurance of Pharmaceuticals- A compendium of Guide lines and Related materials Vol I

WHO Publications.

4. A guide to total Quality Management- Kushik Maitra and Sedhan K Ghosh

5. How to Practice GMP’s – P P Sharma.

6. ISO 9000 and Total Quality Management – Sadhank G Ghosh

7. The International Pharmacopoeia – Vol I, II, III, IV- General Methods of Analysis and Quality

specification for Pharmaceutical Substances, Excipients and Dosage forms

8. Good laboratory Practices – Marshell Deckker Series

9. ICH guidelines, ISO 9000

10. Dr. A. Pillani – the drugs and cosmetics act 1940.

71

3.6 Biopharmaceutics and Pharmacokinetics


Scope: This subject is designed to impart knowledge and skills necessary for dose calculations, dose

adjustments and to apply biopharmaceutics theories in practical problem solving. Basic theoretical

discussions of the principles of biopharmaceutics and pharmacokinetics are provided to help the students’ to

clarify the concepts.


understand the basic concepts in biopharmaceutics and pharmacokinetics.

use plasma data and derive the pharmacokinetic parameters to describe the process of drug

absorption, distribution, metabolism and elimination.

critically evaluate biopharmaceutic studies involving drug product equivalency

design and evaluate dosage regimens of the drugs using pharmacokinetic and biopharmaceutic

parameters.

detect potential clinical pharmacokinetic problems and apply basic pharmacokinetic principles to

solve them


Topics Hrs

I Biopharmaceutics

1 Introduction to Biopharmaceutics 01

2 Absorption; Mechanisms of drug absorption through GIT, factors influencing drug

absorption though GIT, absorption of drug from Non per OS extra-vascular routes

08

3 Distribution of drugs Tissue permeability of drugs, binding of drugs, apparent

volume of drug distribution, protein binding of drugs, factors affecting protein –

drug binding. Kinetics of protein binding, Clinical significance of protein bin-drug

binding.

08

4 Drug Elimination. Biotransformation of drugs, renal excretion of drugs , factors

affecting renal excretion of drugs, renal clearance, Non renal routes of drug

excretion of drugs

06

5 Bioavailability and Bioequivalence: Objectives of bioavailability studies,

absolute and relative bioavailability, measurement of bioavailability, in-vitro drug

dissolution models, in-vitro in-vivo correlations, bioequivalence studies, methods to

enhance the bioavailability.

10

II Pharmacokinetics

6 Introduction to Pharmacokinetics. Mathematical model. Drug levels in blood.

Pharmacokinetic models, Compartment models, Noncompartment models,

physiological models

05

7 One compartment open model. a. Intravenous Injection (Bolus) b. Intravenous

infusion. c. extra vascular administrations, calculations of Ka, KE. From plasma

and urinary excretion data

15

72

8 Multicompartment models: Two compartment open model. IV bolus, IV

infusion and oral administration

08

9 Multiple – Dosage Regimens: a). Repititive Intravenous injections – One

Compartment Open Model b). Repititive Extravascular dosing – One

Compartment Open model c). Multiple Dose Regimen – Two Compartment

Open Model

05

10 Nonlinear Pharmacokinetics. a. Introduction, b. Factors causing Non-linearity.

c. Michaelis-menton method of estimating parameters

05

11 Noncompartmental Pharmacokinetics. Statistical Moment Theory, MRT for

various compartment models.Physiological Pharmacokinetic model

04

Recommended Books

1. Biopharmaceutics and Clinical Pharmacokinetics by, Milo Gibaldi.

2. Biopharmaceutics and Pharmacokinetics; By Robert F Notari

3. Applied biopharmaceutics and pharmacokinetics, Leon Shargel and Andrew B.C.YU 4th edition,

Prentice-Hall Inernational edition.USA

4. Bio pharmaceutics and Pharmacokinetics-A Treatise, By D. M. Brahmankar and Sunil B.Jaiswal,

Vallabh Prakashan Pitampura, Delhi

5. Pharmacokinetics: By Milo Glbaldi Donald, R. Mercel Dekker Inc.

6. Hand Book of Clinical Pharmacokinetics, By Milo Gibaldi and Laurie Prescott by ADIS Health

Science Press.

7. Biopharmaceutics; By Swarbrick

8. Cilincal Pharmacokinetics, Concepts and Applications: By Malcolm Rowland and

9. Thomas, N. Tozen, Lea and Febrger, Philadelphia, 1995.

10. Dissolution, Bioavailability and Bioequivalence, By Abdou H.M, Mack, Publishing Company,

Pennsylvania 1989.

11. Biopharmaceutics and Clinical Pharmacokinetics-An introduction 4th edition Revised and expanded

by Rebort F Notari Marcel Dekker Inn, New York and Basel, 1987.

12. Remington’s Pharmaceutical Sciences, By Mack Publishing Company, Pennsylvnia

73

Fourth year B. Pharm

Sl.

No. Subjects

Theory

hours / week

Practical

hours / week

4.1 Medicinal Chemistry -II 3 3

4.2 Pharmacology – II 3 3

4.3 Formulative and Industrial Pharmacy 3 3

4.4 Instrumental Methods of Analysis 3 3

4.5 Pharmacy Practice 3 ---


Management

3 ---



74

4.1 Medicinal Chemistry – II


Scope: This subject medicinal chemistry; is designed to impart fundamental knowledge on the

structure, chemistry and therapeutic value of drugs. The subject emphasis on modern techniques

of drug design, which include quantitative structure activity relationship (QSAR), Prodrug

concept, combinatorial chemistry, and Computer aided drug design (CADD). The subject

concentrates on the chemistry, mechanism of action, metabolism, adverse effects, Structure

Activity Relationships (SAR) and their therapeutic uses of drugs. The syllabus also emphasises

on synthesis of important drugs.


appreciate the importance of drug design and understand the different modern techniques

of drug design.

understand the chemistry of drugs with respect to their biological activity.

know the metabolism, adverse effect and therapeutic value of drugs.

appreciate the SAR of important class of drug.


Topic Hrs

I. Introduction to Drug Design 07

A. Principles of Drug Design

1. Various approaches used in drug design

2. Physicochemical parameters used in quantitative structure activity relationship

(QSAR) such as partition coefficient, Hammets electronic parameter, Tafts steric

parameter and Hansch analysis.

3. Pharmacophore and docking technique

03

B. Prodrugs: Basic concepts and application of prodrugs design 03

C. Combinatorial Chemistry: Concept and applications of combinatorial chemistry:

solid phase and solution phase synthesis

01

II. Anti-infective agents 16

A. Local anti-infective agents: Ethyl alcohol, Isopropyl alcohol, Formaldehyde,

Sodium glutaraldehyde solution, Liquified phenol, Hexachlorophene*, Eugenol,

Hexyl resorcinol, Anthralin, Hydrous benzoylperoxide, Halazone*, Benzalkonium

chloride*, Methylbenzethorium chloride*, Cetylpyridinium chloride, Chlorhexidine

gluconate*, Gentianviolet, Methylene blue, Thiomersal, Methyl paraben and Sodium

benzoate.

03

B. Antifungal agents:

Antifungal antibiotics: Amphotericin-B, Nystatin, Natamycin and Griseofulvin

03

75

Synthetic Antifungal agents: Clotrimazole, Econazole nitrate, Butoconazole,

Oxiconazole nitrate, Tioconozole, Miconazole*, Ketoconazole, Terconazole,

Itraconazole, Fluconazole, Naftifine hydrochloride, Tolnaftate*, Cyclopiroxolamine.

C. Urinary tract anti-infective agents

Quinolones: SAR of quinolones, Nalidixic Acid*, Cinoxacin, Norfloxacin,

Enoxacin, Ciprofloxacin, Ofloxacin, Lomefloxacin, Sparfloxacin.

Miscellaneous: Furazolidine, Nitrofurantoin* and Methanamine.

03

D. Anti-tubercular Agents

Synthetic anti tubercular agents: INH*, Ethionamide, ethambutol, Pyrazinamide,

Para amino salicylic acid*

Anti tubercular antibiotics: Rifampicin, Rifabutin, Cycloserine* and sterile

Capreomycin sulphate.

03

E. Anti-protozoal Agents: Metronidazole*, Diloxanide*, Iodoquinol, Pentamidine

Isethionate, Atovaquone, Eflornithine

01

F. Anthelmintics: Piperazine salts*, Diethylcarbamazine citrate*, Thiabendazole*,

Mebendazole*, Albendazole, Niclosamide, Oxamniquine, Praziquantal and

Ivermectin.

02

G. Anti-scabious and Anti-pedicular Agents: Benzyl Benzoate*, Lindane*

(Gamaxene), Crotamiton* and Permethrin.

01

III. Antimalarials: Etiology of malaria, SAR

Quinolines: Quinine sulphate, Chloroquine phosphate*, Hydroxy chloroquine sulphate,

Amodiaquine hydrochloride*, Primaquine phosphate, Quinacrine hydrochloride,

Mefloquine

Biguanides and dihydro triazines: Cycloguanil pamoate, Proguanil

Miscellaneous: Pyrimethamine, Trimethoprim and Sulfadoxine

04

IV. Antibiotics

Historical background, Nomenclature, stereochemistry, Structure activity relationship,

chemical degradation classification and important products of the following classes.

β-Lactam antibiotics: Penicillin, Cepholosporins, β- Lactamase inhibitors, Monobactams

Aminoglycosides: Streptomycin, Neomycin

Tetracyclines: Tetracycline, Chlortetracycline, Menocycline, Doxycycline

Macrolide: Erythromycin and Azithromycin

Miscellaneous: Chloramphenicol*, Clindamycin

14

V. Antiviral agents:

Types of virus, stages of viral infection, targets for prevention of viral infections.

Amantadine hydrochloride, Rimantadine hydrochloride, Idoxuridine trifluoride,

Acyclovir*, Gancyclovir, Zidovudine, Didanosine, Zalcitabine, Lamivudine, Ribavirin,

Saquinavir, Indinavir and Ritonavir.

03

76

VI. Anti-neoplastic agents:

Alkylating agents: Meclorethamine*, Cyclophosphamide, Melphalan, Chlorambucil,

Busulfan, Thiotepa

Antimetabolites: Mercaptopurine*, Thioguanine, Fluorouracil, Floxuridine, Cytarabine,

Methotrexate*, Azathioprine

Antibiotics: Dactinomycin, Daunorubicin, hydrochloride, Doxorubicin hydrochloride,

Bleomycin

Plant products: Etoposide, Vinblastin sulphate, Vincristin sulphate

Miscellaneous: Cisplatin and Mitotane

05

VII. Sulphonamides and Sulphones

Historical development, chemistry, classification and SAR of Sulfonamides:

Sulphamethizole, Sulfisoxazole, Sulphamethizine, Sulfacetamide Sodium*,

Sulphapyridine, Sulfamethoxaole*, Sulphadiazine, Mixed Sulfonamides, Mefenide

Acetate, Silver Sulfadiazine, Sulfasalazine

Folate reductase inhibitors: Trimethoprim*, Cotrimoxazole.

Sulfones: Dapsone*

03

VIII. Antihistaminic agents

Histamine, receptors and their distribution in the human body

H1 – antagonists:

Amino alkyl ethers: Diphenhydramine*, Dimenhydrinate, Doxylamine

Ethylene diamines: Tripelennamine, Thonzylamine

Piperazine derivatives: Meclizine, Buclizine, Chlorcyclizine, Cetirizine

Propylamine derivatives: Chlorpheniramine*, Pheniramine

Tricyclic derivatives: Promethazine*, Trimeprazine, Phenidamine, Cyproheptadine,

Azatidine

Second generation non sedating: Astemizole, Loratadine, Cetirizine, Acrivastine

H2-antagonists: Development of selective H2 antagonists - Cimetidine*, Famotidine,

Ranitidine

Gastric Proton pump inhibitors: Omeprazole and Lansoprazole.

05

IX. Prostaglandins and other eicosanoids: History and discovery; eicosanoid biosynthesis;

drug action mediated by eicosanoids; design of eicosanoid drugs; eicosanoids approved for

human clinical use.

05

X. Sex hormones:

Androgens: testosterone

Estrogens: Esterodiol, Estrone, Estriol, Diethyl Stilbestrol

Progesterone and Oral contraceptives

04

XI. Non Steroidal Anti-inflammatory Drugs & antigout

Anti-inflammatory agents: Sodium salicylate, Aspirin, Salsalate*, Mefenamic acid,

Meclofenamate sodium, Indomethacin*, Sulindac, Tolmetin sodium, Zomepriac sodium,

Diclofenac sodium, Ketorolac, Ibuprofen*, Naproxen*, Piroxicam, Phenacetin,

04

77

Acetaminophen, Antipyrine, Aminopyrine, Phenylbutazone* and Oxyphenbutazone.

XII. Narcotic analgesic:

Morphine and related drugs: SAR of Morphine analogues, Morphine sulphate, Codeine

phosphat, Hydromorphone hydrochloride, Meperidine hydrochloride*, Alphaprodine

hydrochloride, Anilerdine hydrochloride, Diphenoxylate hydrochloride, Loperamide

hydrochloride, Fentanyl citrate*, Methadone hydrochloride*, Propoxyphene

hydrochloride, Pentazocine, Levorphanol tartarate.

Narcotic antagonists: Nalorphine hydrochloride, Levallorphan tartarate and Naloxone

hydrochloride,

Anti-tussives: Noscapine, Dextromethorphan hydrobromide and Benzonatate,

Carbetapentane.

05

78

4.1 Medicinal Chemistry – II (Practical)



I Assay of medicinal compounds

1. Chloroquine by non aqueous titration.

2. Ascorbic acid by iodimetry

3. Isonicotinic acid hydrazide by bromometry

4. Benzyl penicillin by iodometry.

5. Metronidazole by non-aqueous titration.

6. Dapsone by diazotisation

7. Phenols by formaldehyde

05

II Preparation of medicinally important compounds or intermediates

required for synthesis of drugs.

1. 2-Methyl benzimidazole from o-Phenylene diamine.

2. 2,3-Diphenyl quinoxaline from o-Phenylene diamine

3. Paracetomol from P-Amino phenol

4. Benzotriazole from O-phenylene diamine.

5. PAS from p-nitro salicylic acid

6. Fluorescein from Pthalic anhydride

7. Eosin from Fluorescein

8. p- Acetamido benzene sulphonyl chloride from Acetanilide

9. Sulphanilamide from p- Acetamido benzene sulphonyl chloride

10. Benzyl alcohol by Cannizoro’s reaction

11. Chlorobutanol from Chloroform

12. Acedoben from PABA

13. Halazone from 4-(Aminosulfonyl)benzoic acid

14. Nitrofurazone from 2-Formyl-5-nitrofuran

10

III Preparation of medicinally important compounds or intermediates by

Microwave irradiation technique

2

IV Monograph analysis of selected drugs from course content

1. Aspirin

2. Paracetamol

3. INH

2

V Determination of partition co-efficient and dissociation constant of

compounds

3

VI Determination of physicochemical properties such as logP, clogP, MR,

Molecular weight, Hydrogen bond donors and acceptors for class of

drugs course content using drug design software

3

79

Recommended Books

1. Wilson and Giswold’s Organic medicinal and Pharmaceutical Chemistry, 11th edition.

2. Foye’s Principles of Medicinal Chemistry, 5th edition.

3. Burger’s Medicinal Chemistry, Vol I to IV.

4. Introduction to principles of drug design- Smith and Williams.

5. Remington’s Pharmaceutical Sciences, 20th edition.

6. Martindale’s extra pharmacopoeia.

7. Organic Chemistry by I.L. Finar, Vol. II.

8. The Organic Chemistry of Drug Synthesis by Lednicer, Vol. 1-5.

9. Indian Pharmacopoeia 1996 and 2007 editions.

10. Text book of practical organic chemistry- A.I.Vogel, 5th

edtion.

80

4.2 Pharmacology –II (Theory)


Scope: This subject is intended to impart the fundamental knowledge on various aspects

(classification, mechanism of action, therapeutic effects, clinical uses, side effects and

contraindications) of drugs used in systemic diseases as well as infectious diseases. In addition,

emphasizes on the basic concepts of bioassays and principles of toxicology.


understand the mechanism of drug action and its relevance in the treatment of different

diseases

comprehend the principles of toxicology and treatment of various poisonings.

locate and isolate different organs/tissues from the laboratory animals used in

pharmacological experiments

demonstrate the various receptor actions using isolated tissue preparation

appreciate correlation of pharmacology with related medical sciences


Topic Hrs

1. Pharmacology of Endocrine System

a. Basic concepts in endocrine pharmacology.

b. Hypothalamic and pituitary hormones.

c. Thyroid hormones and anti thyroid drugs, Parathormone, Calcitonin and

Vitamin-D.

d. Insulin, Oral Hypoglycemic agents and glucagon.

e. ACTH and corticosteroids.

f. Androgens and Anabolic steroids.

g. Estrogens, progesterone and oral contraceptives.

h. Drugs acting on the uterus.

19

2. Pharmacology of Drugs acting on the Gastrointestinal Tract

a. Antacids, anti-secretary and anti ulcer drugs.

b. Laxatives and anti-diarrheal drugs.

c. Appetite stimulants and suppressants.

d. Digestants and carminatives.

e. Emetics and anti-emetics.

8

3. Chemotherapy

a. General Principles of Chemotherapy.

b. Sulfonamides and co-trimoxazole.

c. Antibiotics- Penicillins, Cephalosporins, Chloramphenicol, Erythromycin,

Quinolones and Fluoroquinolins, tetracycline and aminoglycosides

24

81

d. Chemotherapy of tuberculosis, leprosy, fungal diseases, viral diseases,

antiprotozoal drugs, anthelminitics, urinary tract infections and sexually

transmitted diseases.

e. Chemotherapy of malignancy.

4. Autacoids

a. Histamine, 5-HT and their antagonists.

b. Prostaglandins, Thromboxanes and Leukotrienes.

c. Pentagastrin, Cholecystokinin, Angiotensin, Bradykinin and Substance P.

d. Analgesic, anti-pyretic, anti-inflammatory and anti-gout drugs.

9

5. Principles of Toxicology

a. Definition of poison, general principles of treatment of poisoning.

b. Heavy metals and heavy metal antagonists.

c. Definition for acute, sub acute and chronic toxicity, genotoxicity,

a. Carcinogenicity, teratogenicity and mutagenicity studies.

6

6. Chronopharmacology: Definition of rhythm and cycles. Biological clock and

their significance leading to chronotherapy.

2

7. Bioassay: Principles and methods of bioassay. Bioassay of insulin, oxytocin,

vasopressin, ACTH, histamine and 5-HT

4

8. Immunopharmacology: Immunostimulants and immunosuppresants 3

82

4.2 Pharmacology –II (Practical)

Practical: 3Hrs/Week


1. Introduction to in-vitro pharmacology and physiological salt solutions. 3

2. Experiments on isolated preparations:

a. To record CRC of acetylcholine by using suitable muscle preparations.

b. To record the CRC of 5HT on rat fundus preparation.

c. To record CRC of Nor adrenaline on rat anococcygeus muscle

preparation.

d. To record the agonistic and antagonistic response by using suitable

muscle preparations.

e. To estimate the strength of the test sample of agonist/ drug (e.g.

Acetylcholine, Histamine, 5HT, Oxytocin etc) using a suitable isolated

muscle preparation employing matching bioassay, interpolation

bioassay, three point bioassay and four point bioassay.

12

3. Estimation of bioavailability parameters viz AUC, Tmax, Kel from blood and

urine samples in human volunteers or in laboratory animals.

2

4. Alternate methods for animal experimentation for both efficacy and toxicity

studies.

3

5. Estimation of serum biochemical parameters by using semi- autoanalyzer. 2

Recommended books

1. Craig C.R. and Stitzel R.R, Modern Pharmacology.

2. Ghosh M. N, Fundamentals of experimental Pharmacology.

3. Katzung B.G, Basic and Clinical Pharmacology, Prentice Hall International.

4. Laurence D.R and Bennet P.N. Clinical Pharmacology Churchill Livingstone.

5. Mycek M.J, Gelnet S.B and Perper M.M, Pharmacology, Lippincott’s illustrated Reviews.

6. Rang M.P, Dale M.M, Reter J.M, Pharmacology.

7. Goodman and Gilman’s, The Pharmacological basis of Therapeutics.

8. S.K. Kulakarni. Hand book of Experimental Pharmacology.

9. N.Udupa and P.D. Gupta, Concepts in Chronopharmacology.

83

5.3 Formulative and Industrial Pharmacy (Theory)


Scope: Course enables the student to understand and appreciate the influence of pharmaceutical

additives and various pharmaceutical dosage forms on the performance of the drug product.

Objectives:

Upon completion of the course the student shall be able to

know the various pharmaceutical dosage forms and their manufacturing techniques.

know various considerations in development of pharmaceutical dosage forms

formulate solid, liquid and semisolid dosage forms and evaluate them for their quality


Topic Hrs

1. Preformulation Studies: Study of physical/physicochemical properties of drugs

like physical form, particle size, shape, density, wetting, dielectric constant,

solubility, dissolution, organoleptic properties and their effect on formulation,

stability & bioavailabilty. Study of chemical properties of drugs like hydrolysis,

oxidation, reduction, racemisation, polymerization etc. and their influence on

formulation.

5

2. Tablets: Classification of different types of tablets, tablets equipments,

granulation technology on large scale by various techniques. Tablets tooling,

different types of tablets compression machinery, processing problem of tablets

and evaluation of tablets.

Coating of tablets: Types of coating, Sugar coating, film forming materials,

formulation of coating solution, equipment for coating, film defects and

evaluation of coated tablets.

8

3. Capsules: Advantages & disadvantages of capsule dosage form, extraction of

gelatin, production of hard gelatin capsules, size of capsules and method of

capsule filling. Soft gelatin capsule, Nature of capsule shell & capsule content,

importance of base adsorption, minim/ gm factors in soft capsules, production,

quality control, stability testing and storage of capsule dosage forms.

6

4. Parenteral Products: Preformulation factors, routes of administration, water for

injection, pyrogenicity, non-aqueous vehicles, isotonicity & methods of its

adjustment. Formulation details, containers and closures and their selection.

Prefilling treatment, washing the container and closers, preparation of solution

and suspension, filling, closing of ampoules, vials infusion fluids, lyophilization,

preparation of sterile powders, equipment for large scale manufacture and

evaluation of parenteral products.

8

84

Aseptic techniques: Source of contamination, methods of prevention, design of

aseptic area, laminar flow bench, air handling units, services and maintenance.

5. Microencapsulation: Types of microcapsules and their importance,

microencapsulation by co-acervation phase separation, multi orifice

centrifugation, spray drying, spray congealing, polymerization, air suspension,

pan coating & other techniques, evaluation of microcapsules.

8

6. Packaging of Pharmaceuticals

Desirable features and a detailed study of different types of Pharmaceutical

Containers and closures (Glass, Plastics and Rubber), including their merits and

demerits Selection and evaluation of Pharmaceutical packaging materials.

4

7. Ophthalmic Formulations: Requirements, formulation of eye drops, eye

ointments and introduction to occuserts, containers and evaluation.

4

8. Pharmaceutical Aerosols: Definition, propellants, containers, valves, types of

aerosol systems, manufacture of aerosol, quality control and stability studies.

8

9. Controlled Delivery Systems: Principle, Advantages & disadvantages, selection

of drug candidates, various approaches to design controlled release formulations,

graphical presentation of sustained release, prolonged action, repeated release,

controlled release, pulsatile release pharmaceuticals.

4

10. Novel Drug Delivery Systems: Transdermal delivery systems, osmotic drug

delivery systems, buccal drug delivery systems.

4

11. Cosmetics: Formulation and preparation of the following cosmetic preparations:

Lipsticks, shampoos, face and talcum powders, nail lacquers, tooth pastes and

hair dyes.

8

12. Pilot plant scale up techniques: Significance of pilot plant scale up study, Large

scale manufacturing techniques formula, equipment, process, stability and quality

control) of solids, liquids and semisolid dosage forms.

8

13. Stability Studies: Basic concept and objectives of stability study. Importance of

accelerated stability study. Effect of various environments/processing on stability

of the formulation and techniques for stabilization of products against the same.

Regulatory requirements related to stability testing with emphasis on ICH

Guidelines, matrixing / bracketing techniques, climatic zone, impurities in

stability study, photo stability testing etc.

8

85

4.3 Formulative and Industrial Pharmacy (Practical)



1. Preformulation studies on prepared granules 1

2. Manufacture and evaluation of granules

a. ordinary compressed tablet- wet granulation

b. tablets prepared by direct compression

c. soluble tablet

d. chewable tablet

4

3. Formulation and filling of hard gelatin tablets 1

4. Manufacture of parenteral

a. Ascorbic acid injection

b. Calcium gluconate injection

c. Sodium chloride injection

d. Dextrose and sodium chloride injection/infusion

4

5. Preparation of microcapsules

a. Non-solvent method

b. Salt-addition method

2

6. Cosmetic preparations

a. Lipsticks

b. Cold cream and vanishing cream

c. Clear liquid shampoo

d. Tooth paste and tooth powder

4

7. Tablet coating (demo) 1

Recommended Books

1. Pharmaceutical dosage forms - Tablets, volume 1 -3 by H.A. Liberman, Leon Lachman

& J.B.Schwartz

2. Pharmaceutical dosage form - Parenteral medication vol- 1&2 by Liberman & Lachman

3. Pharmaceutical dosage form disperse system VOL-1 by Liberman & Lachman

4. Modern Pharmaceutics by Gilbert S. Banker & C.T. Rhodes, 3rd

Edition

5. Remington: The science and practice of pharmacy, 20th edition Pharmaceutical Science

(RPS)

6. Theory And Practice Of Industrial Pharmacy by Liberman & Lachman

7. Novel Drug Delivery System by Y.W.Chein

8. Pharmaceutics-the science of dosage form design by M.E.Aulton, Churchill livingstone,

Latest edition

9. Introduction to Pharmaceutical Dosage Forms by H. C.Ansel, Lea & febiger,

Philadelphia, 5th edition, 2005

10. Drug stability - Principles and practice by Cartensen & C.J. Rhodes, 3rd

Edition, Marcel

Dekker Series, Vol 107.

86

4.4 Instrumental methods of analysis (Theory)


Scope: This subject is designed to impart a fundamental knowledge on the testing of drugs by

various instrumental methods of analysis. This focuses on various modern instruments that are

used for testing the purity of drugs in various dosage forms. This course also gives knowledge

about modern instruments that are used for drug testing like NMR, IR, Mass, HPLC, HPTLC etc,


know the principle and applications of instrumentation

understand the components and working of various analytical instruments.

understand the different modern techniques of drug analysis.

appreciate the advantages of instrumental methods of drug analysis.


Topic Hrs

1. UV/Visible spectroscopy

1.1 Theory of atomic and molecular spectra, Electronic transitions, Beer and

Lambert’s law, Derivation and deviations, Applications of Beer law to single and

multi component systems, Chromophores, Auxochromes, Spectral shifts, Solvent

effect on absorption spectra.

Instrumentation - Sources of radiation, wavelength selectors, sample cells,

Detectors- Barrier layer cell, Photo tube, Photomultiplier tube, Silicon

Photodiode.

Applications - Spectrophotometric titrations, Measurement of equilibrium

constant and rate constant.

10

1.2 IR spectroscopy – Introduction, Fundamental modes of vibrations in

poly atomic molecules. Sample handling, Instrumentation - Sources of radiation,

wavelength selectors, sample cells, Detectors – Golay cell, Bolometer,

Thermocouple, Thermister, Pyrroelectric detector. Structure - frequency

correlation with examples.

4

1.3 Atomic absorption spectroscopy - Introduction, Theory, instrumentation, and

applications.

2

2. 2.1 Fluorimetry – Theory, Concepts of singlet, doublet and triplet electronic states,

internal and external conversions, factors affecting fluorescence, quenching.

Instrumentation and applications

3

2.2 Flame emission spectroscopy – Introduction, Theory, Instrumentation,

Interferences and applications

3

87

3. Nephelometry and Turbidimetry – Theory, Instrumentation and applications. 2

4. NMR Spectroscopy - Principles, Instrumentation and applications. 3

5. Mass Spectroscopy - Principles, Fragmentation, Instrumentation, applications.

Introduction to MALDI and ICPMS

3

6.

7.

8

X- Ray diffraction studies – Introduction, diffraction methods and applications.

Thermal Methods of Analysis: Theory, Instrumentation and applications of

Differential Scanning Calorimetry (DSC)

Chromatography

2

2

8.1 Adsorption and partition column chromatography – Methodology,

advantages, disadvantages and applications

2

8.2 Thin layer chromatography – Introduction, Principle, Methodology, Stahl’s

triangle, Rf values, advantages, disadvantages and applications.

2

8.3 High Performance Thin Layer Chromatography (HPTLC) – Introduction,

instrumentation, advantages, application.

2

8.4 Paper chromatography – Introduction, Principle, Methodology, developmental

techniques, advantages, disadvantages, applications.

2

8.5 Ion exchange chromatography – Introduction, Definition, classification, ion

exchange resins, properties, mechanism of ion exchange process, Factors

affecting ion exchange, methodology, applications.

3

8.6 High Performance Liquid Chromatography (HPLC) – Introduction, theory,

instrumentation, advantages and applications. Introduction to UPLC and super

critical fluid chromatography

4

8.7 Gas Chromatography - Introduction, theory, instrumentation, derivatization,

temperature programming, advantages, disadvantages and applications.

4

8.8 Electrophoresis - Principle of separation, classification, equipment for moving

boundary electrophoresis, gel, paper electrophoresis and applications.

3

8.9 Gel Filtration Chromatography – Introduction, technique, factors affecting,

Applications.

2

9. Electro chemical methods of analysis

9.1 Condutometry - Introduction, Conductivity cell, Conductometric titrations,

applications.

3

9.2 Potentiometry – Electrochemical cell, construction and working of reference

and indicator electrodes, methods to determine end point of titration.

10. Quality assurance

A. Calibration and validation of following Instruments

UV-Visible spectrophotometer, pH meter, HPLC, Electronic balance, Conductivity

meter, IR spectrophotometer, Fluorimeter, Flame Photometer

B. Introduction to analytical method development

6

88

4.4 Instrumental Methods of Analysis (Practical)



1. Separation & identification of amino acids by paper chromatography 1

2. Separation & identification of alkaloids by TLC 1

3. Conductometric titration of Benzoic acid with NaOH 1

4. Potentiometric titration of HCl with NaOH 1

5. Estimation of Quinine sulphate by fluorimetry 1

6. Estimation of riboflavin by fluorimetry 1

7. Study of quenching effects in fluorimetry by iodide ions 1

8. Determination of absorption maxima of a compound 1

9. Determination of primary amines by PDAB or NQS reagents method 1

10. Colorimetric estimation of Sulphanilamide using BM reagent 1

11. Determination of pKa of weak acid by colorimetry 1

12. Determination of Ibuprofen and Paracetamol by simultaneous equation

method

1

13. Determination of Chloride and Sulphate by Nepheloturbidometry 1

14. Kinetics of Aspirin hydrolysis 1

15. Determination of Sodium/Potassium by flame photometry 1

16. Determination of water content by Karl Fischer electrometric titration method 1

17. IR interpretation of drug samples with different functional groups 1

18. IR, NMR, Mass spectral interpretation of some organic compouds 1

19. Impurity profiling (Determination of related substance) by HPLC 1

20. Estimation of organic compound by GC method 1

21. DSC Demonstration 1

89

Recommended Books

1. Instrumental methods of analysis by Hobarth Willard, Lynne L Merritt and John A Dean,

7th edition, CBC publishers, New Delhi.

2. Kennith A Connors, A Text Book of Pharmaceutical Analysis, 3rd

edition, John Wiley

and sons, New york (1982)

3. William Kemp, Spectroscopical methods, ELBS.

4. Indian Pharmacopoeia.

5. United States Pharmacopoeia.

6. British Pharmacopoeia.

7. Higuchi T and Hanssen E.B., Text Book of Pharmaceutical Analysis, A Wiley

Interscience Publications.

8. Instrumental methods of chemical analysis by Gurudeep Chatwal and Sham Anand,

Himalaya publishing house, 2002.

9. Instrumental methods of chemical analysis by B. K. Sharma, 10th edition, GOEL

publishing house, 2002.

10. Principles of instrumental analysis by Doglas A Skoog, F. James Holler, 5th edition,

Eastern press, Bangalore, 1998

11. Practical pharmaceutical chemistry by Beckett A. H. and Stenlake J. B., 4th edition, CBS

publishers, New Delhi, 1997

12. Spectrometic identification of organic compounds by Robert M Silverstein, G. Clayton

and Terence C. Morill, 6th

edition, John Wiley and Sons, 2004

13. Quantitative analysis of drugs in Pharmaceutical formulation – P. D. Sethi, 3rd

edition,

CBS Publishers, New Delhi, 1997.

90

4.5 Pharmacy Practice (Theory)


Scope: This course is designed to impart basic knowledge and skills that are required for the

practice of pharmacy in both hospital and community settings.

Objectives: Upon completion of this course it is expected that students shall be able to

understand the various drug distribution system

handle the prescriptions and manage community pharmacies

understand the elements of pharmaceutical care and provide comprehensive patient

care services

understand the concept and practice of the quality use of medicines

summarize the therapeutic approach for management of various diseases including

reference to the latest available evidence.


Topic Hrs

A) Hospital & Community Pharmacy 25

Hospital and its organization: Definition and classification of hospital - Primary,

Secondary and Tertiary hospitals; organizational structure and functions of a

hospital.

2

Hospital pharmacy and its organization: Definition, organizational structure

and functions of hospital pharmacy.

2

Pharmacy and therapeutic committee (PTC): Composition and functions of

pharmacy and therapeutics committee

1

Budget preparation and implementation 1

Hospital formulary (HF): Definition, content, preparation and revision of

hospital formulary

2

Drug store management and inventory control

Organization of drug store, types of materials, stocked and storage conditions

Purchase and inventory control, purchase order, procurement and stocking

Methods in inventory control

5

Drug distribution system in a hospital

Types of drug distribution systems, charging policy and labeling.

Dispensing of controlled drugs.

3

91

Community Pharmacy: Organization and structure of retail and wholesale drug

store, types and design of drug store, legal requirements for establishment and

maintenance of a drug store, dispensing of proprietary products, maintenance of

records of retail and wholesale, finance, staff and infrastructure requirements.

7

Prescribed medication order: Interpretation and legal requirements

Over the counter (OTC) sales: Rational use of common OTC medications

(vitamins, tonics, iron preparations, analgesics, NSAIDS, cough mixtures, anti-

diarrheal preparations)

1

B) Clinical Pharmacy 25

Introduction to Clinical Pharmacy: Definition, concept, scenario of clinical

pharmacy and pharmaceutical care.

3

Daily activities of a clinical pharmacist: Ward round participation, drug therapy

monitoring (medicines review), treatment chart review, clinical review, pharmacist

intervention, adverse drug reaction management, drug and poison information

service, patient medication history and patient medication counseling.

8

Drug information services: Drug information centre, drug information resources,

answering drug information query.

3

Adverse drug reaction (ADR): Definition, types, predisposing factors, detection,

reporting, management and prevention of ADR, role of pharmacist in the

management of ADR.

3

Medication adherence: Causes of medication non- adherence; pharmacist role in

the medication adherence; monitoring of patient medication adherence.

1

Medication errors: Definition, types, categories, sources and management of

medication errors.

2

Therapeutic drug monitoring (TDM): Definition, need for TDM and factors

influencing TDM

1

Clinical Trials: Definition, various phases, designs and conduct of clinical trials 4

C) Therapeutics 25

Basic pathophysiology and pharmacotherapy of the following disorders

Cardiovascular system: Hypertension and myocardial infarction 4

Respiratory System: Asthma 2

Renal System: Acute Renal Failure 2

Endocrine System: Diabetes 2

Nervous System: Epilepsy and stroke 4

Gastrointestinal System: Peptic ulcer disease 2

Disease of bones and joints: Rheumatoid arthritis 2

Infectious Diseases: Guideline for rational use of antibiotics, Tuberculosis,

Malaria, Pneumonia, Urinary tract infection

7

92

Recommended Books

1. Hospital Pharmacy by William E. Hassan.

2. A textbook of Hospital Pharmacy by S.H. Merchant and J.S. Quadry.

3. Clinical Pharmacy and Hospital Drug Management by David H Lawson and R Michael

E. Richards.

4. Clinical Pharmacy by Tipnis Bajaj.

5. A textbook of Clinical Pharmacy Practice- essential concepts and skills by Dr. G.

Parthasarathi, Nyfort-Hansen Karin, Milap Nahata.

6. Basic skills in interpreting laboratory data - Scott LT, American Society of Health

System Pharmacists Inc (latest edition)

7. Health Education and Community Pharmacy by Parmar N.S., CBS publishers.

8. Pathologic basis of disease : Robbins SL, W.B. Saunders publication

9. Pathology and therapeutics for Pharmacists: A Basis for Clinical Pharmacy Practice -

Green and Harris, Chapman and Hall publication

10. Clinical Pharmacy and Therapeutics - Eric T. Herfindal, Williams and Wilkins

Publication

11. Applied Therapeutics: The clinical Use of Drugs. Lloyd Young and Koda-Kimble MA,

Williams and Wilkins Publication

12. Avery’s Drug Treatment, 4th Edn, 1997, Adis International Limited.

93

4.6 Pharmaceutical marketing and management (Theory)

Theory: 75 Hrs 75 Hrs (3Hrs/Week)

Scope: This course gives the general management principles and pharmaceutical marketing

systems, different types of market & marketing authorization and competitive practices in

pharmaceutical industries. Marketing aspect covers types of market, principles of marketing and

pharmaceutical product.


know pharmaceutical market systems

understand marketing mix and marketing communications

understand the basic principles of management sciences

appreciate the importance of marketing in product promotion.


Topic Hrs

1 Marketing:

a. The meaning and scope of marketing

b. The pharmaceutical market: Quantitative and qualitative aspects, size and

composition of the market, demographic descriptions and socio-psychological

characteristics of the consumer, market segmentation.

c. Analyzing the market - Role of market research

d. Consumer profile – Motivation and prescribing habbits of the physician,

patients choice of physician and retail pharmacist

11

2 The pharmaceutical product

a. Market consideration in product development, marketing mix, product life

cycle (PLC), effects of different elements of marketing mix at different stages of

PLC, product classification, product planning, product differentiation, me-too

products, modification of existing product.

b. New product development-All stages from the new product idea to the stage of

marketing the developed product (bulk drug and formulations).

c. Branding-concept of brand, different types of brand, importance and reasons

for branding, packaging.

6

3 Competitive practice in the pharmaceutical industry

a. Patent laws, Trademark laws

b. Price competition-pricing, rate contracts.

c. Non-price competition-All types of non-price competition with special

emphasis on competition through research and development, competition through

quality

4

94

4 Distribution

a. The wholesaler-His role in distribution of pharmaceutical services offered to

the manufacturer and the retailer, advantages and disadvantages of distribution

through wholesaler.

b. The retailer-Classification of retail institutions, advantages and disadvantages of retail institutions, the hospital as retail outlet.

4

5 Promotions

a. Communication and its importance

b. Different types of promotion-Advertising, Direct mail, Professionals, Journals,

Sampling, Retailing, Medical exhibition, Public relations

c. Professional sales representatives (PSR)-Duties of PSR, Purpose of detailing,

selection and training, compensation and future prospects of PSR

5

6 Management:

a. Concepts of management, principles of management, objectives of

management, manager-role and types, ,

b. Primary functions of management – planning, organizing, staffing, directing,

controlling, motivation, entrepreneurship development

c. Secondary functions of management – decision-making, leadership,

innovation, delegation of authority/responsibility

10

7 The organization:

Organisational structure, function, departmentialisation, basic principles of

organization. Manufacturer objectives, influence of internal controls such as

company policy on the company’s operation, effects of government regulations

and controls of marketing practices

4

8. Six sigma-introduction, methods(DMAIC), role, levels, software used and applications

6

Recommended Books

1. Heinz Weihrich, Harold Koontz: Management: A global Perspective, McGraw Hill

International Edition, Tenth edition.

2. S.V.R. Subba Rao, Pharmaceutical Marketing in India, Asian Institute of Pharmaceutical

Marketing, Hyderabad, 1998 edition.

3. Mickey C. Smith, Principles of Pharmaceutical Marketing, CBS publishers and

distributors, New Delhi, 3rd

edition.

4. C.V.S. Subrahmanyam. Pharmaceutical production and management, Vallabh Prakashan

publisher, New Delhi, 2005.

5. Peter F. Drucker, Management-tasks, responsibilities, practices. Allied Publishers Pvt

Ltd., Mumbai, 2003.

6. Mickey C. Smith, Pharmaceutical Marketing in the 21st Century, pharmaceutical product

press, New York, USA, 1996

7. Sachin Itkar, Pharmaceutical Management, Nirali Prakashan Publishers, Pune, 2007.

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