master of pharmacy (pharmaceutics)tmu.ac.in/.../6/2016/05/syllabusmpharmapharmaceutics1213.pdfm....

M. Pharm (Pharmaceutics) Revised Syllabus Applicable w.e.f. Academic Session 2011-12 (01112012) of 20

Study & Evaluation Scheme

of

Master of Pharmacy

(Pharmaceutics) [Applicable w.e.f. Academic Session 2011-12 till revised]

[With amendments in Credit scheme, MPU 251, 351 & 451 vide approval dated 17th

Nov 2012]

TEERTHANKER MAHAVEER UNIVERSITY N.H.-24, Delhi Road, Moradabad, Uttar Pradesh-244001


Website: www.tmu.ac.in


of

MASTER OF PHARMACY

SUMMARY

Programme : M. Pharm. (Pharmaceutics)

Duration : Two years full time

Medium : English

Minimum Required Attendance : 75 %

Credit

Maximum Credits : 71 Minimum credits required for degree : 66

Assessment

:

Internal External Total

30 70 100

Internal Evaluation (Theory Papers) :

Clas

s

Test

I

Clas

s

Test

II

Clas

s

Test

III

Continuou

s

Evaluatio

n

Semin

ar

Total

10 10 10 5 5 30

Duration of Examination :

Theory Practical

External Internal External Internal

3 hrs. 1.5 hrs. 4 hrs. 4 hrs.

To qualify the course a student is required to secure a minimum of 40% marks in aggregate in the end

semester examination and teachers continuous evaluation (i.e. both internal and external). A candidate who

secures less than 40% of marks in a course shall be deemed to have failed in that course. The student should

have overall 50% marks in a semester to clear the semester. In case a student has more than 40% in each

course but less than 50% overall in a semester he/she shall re-appear in one or two course(s) to improve the

percentage. There will be three Class Tests in a semester and an average of the marks obtained in best two

tests will be computed (cumulatively) for the final result.

The class tests would comprise of five questions. Student shall have to answer three questions out of which

one question will be compulsory. Each question would be of five marks.

Question Paper Structure:

1. The question paper shall consist of eight questions. Out of which first question shall be of short

answer type (not exceeding 50 words) and will be compulsory. Question No. 1 shall contain 8 parts

representing all units of the syllabus and students shall have to answer any five (weightage 4 marks

each).

2. Out of the remaining seven questions, a student shall be required to attempt any five questions.

There will be minimum one and maximum two questions from each unit of the syllabus. The

weightage of Question No. 2 to 8 shall be 10 marks each.

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Programme: M. Pharm. Semester I

S.N.

Course

Code

Subject Periods

C

Evaluation Scheme

L T P Internal External Total

1 MPA101 Modern Analytical Techniques 4 2 - 5 30 70 100

2 MPU101 Pharmaceutical Biostatics and

Computer Application

4 2 - 5 30 70 100

3 MPU102 Product Development 4 2 - 5 30 70 100

4 MPA151 Modern Analytical Techniques

(MAT) Lab

- - 8 4 30 70 100

Semester II

S.N.

Course

Code

Subject Periods Credits Evaluation Scheme


1 MPU201 Pharmaceutical Production

Management

4 2 - 5 30 70 100

2 MPU202 Recent Advances in Drug

Delivery System

4 2 - 5 30 70 100

3 MPU203 Bio-pharmaceutics &

Pharmacokinetics

4 2 - 5 30 70 100

4 MPU251 Research Project Synopsis - 2 - 1 100 0 100

5 MPU252 Recent Advances in Drug

Delivery System Lab

- - 8 4 30 70 100

6 MPU253 Bio-pharmaceutics &

Pharmacokinetics Lab

- - 8 4 30 70 100

Total 12 8 16 24 250 350 600

Semester III

S.N.

Course

Code



1 MPU351 Research Project Phase -I - - 48 6 100 0 100

Total - - 48 6 100 0 100

Semester IV

S.N.

Course

Code



1 MPU451 Research Project Phase -II

(Thesis compilation and

Viva-Voce)

- - 48 18 25 75 100

Total - - 48 18 25 75 100

Research Project shall be carried out in different stages. It will commence with submission and approval of

synopsis in second semester. The experimental work shall be carried out in two phases i.e. in III & IV

semesters.

Note: L – Lecture T- Tutorial P- Practical C- Credits

1L = 1Hr 1T= 1 Hr 1P=1 Hr 1C =1Hr of Theory paper

= 2Hrs of Practical

5 MPU152 Product Development Lab - - 8 4 30 70 100

Total 12 6 16 23 150 350 500


M. Pharm. – Semester I

MODERN ANALYTICAL TECHNIQUE

Course Code: MPA101 L-4, T-2, P-0, C-5

Objective: The basic objective of this course is to get familiar with Principle, theory &

instrumentation of sophisticated pharmaceutical analysis instruments and the interpretation of their spectra.

Unit - 1

Principle, theory & instrumentation of UV-Visible spectroscopy, it’s utility in structural qualitative

and quantitative analysis of drug molecules, Woodward Fischer rules and use of Shiff’s reagents for

elucidation of structure. (8 Hours)

Unit – 2

Infrared spectroscopy, I.R radiation and its interaction with organic molecules, vibrational mode of

bonds, instrumentation and application, effect of hydrogen bonding and conjugation on absorption

bands, interpretation of IR Spectra, FTIR and ATR. (8 Hours)

Unit – 3

Nuclear magnetic resonance spectroscopy: chemical shift concept, isotopic nuclei, reference

standards and solvents. 1H NMR spectra, coupling constants, interpretation of spectra, decoupling-double resonance and shift reagent methods.

Principles of FT-NMR with reference to 13C NMR, free induction decay. Spin-spin and spin-lattice

relaxation phenomenon. Nuclear overhauser enhanced 13C NMR spectra, their interpretation and

application. (8 Hours)

Unit – 4

Mass spectrometry: Basic principles and brief outline of instrumentation. Ion formation, molecular

ion, metastable ion, fragmentation process in relation to molecular structure and functional groups.

Relative abundance of isotopes, chemical ionization, GC-MS and LC/MS. Interpretation of spectra

of simple molecules. (8 Hours)

Unit – 5

Chromatographic techniques: Principles of separation and application of Column, Paper, Thin layer and Gas chromatography, HPLC, HPTLC, Electrophoresis. Instrumentation of HPLC, Reverse phase

columns. Pharmaceutical evaluation of drug in biological fluids- bioassays. Radioimmunoassay.

(8 Hours)

Recommended Books

1. Willard, H.H., Merrit, L.L., Dean, J.A., Settle, P.A., Instrumental Methods of Analysis, Van

Nostrand. 2. Skoog, D.A., Heller, F.J., Nieman, T.A., Principles of Instrumental Analysis, WB Saunders.

3. Haswell, S.J., ed. Atomic Absorption Spectroscopy, Elsevier. 4. Ardrey, R.E., Pharmaceutical Mass Spectra, Pharmaceutical Press, London.

5. Sethi, P.D., Quantitative Analysis of Pharmaceutical Formulations, CBS Publishers, New Delhi. 6. Kalsi, P.S., Spectroscopy of Organic Compounds, New Age Publishers, New Delhi.

7. Gross J.H., Mass Spectrometry, Springer Berlin, Heidelberg. 8. Haffmann D. H., Advances in Chromatography, Marcel Dekker.

9. Robert D. Braun, Introduction to Instrumental Analysis, McGraw-Hill.

10. Wilfried, M.A. Niessen- Liquid Chromatography-Mass Spectrometry, Marcel Dekker.

*Latest editions of all the suggested books are recommended.


Semester I

PHARMACEUTICAL BIOSTATICS AND COMPUTER APPLICATIONS

Course Code: MPU101 L-4, T-2, P-0, C-5

Objective: The basic objective of this course is to get familiar with pharmaceutical biostatics and

computer applications.

Unit - 1 Methods of collection of data, classifications and graphical representation of data. Binomial and

normal probability distribution. Polygon, histogram, measure of central tendency. Significance of

statistical methods, probability, degree of freedom, measures of variation - Standard deviation,

Standard error. (8 Hours)

Unit - 2

Sampling, sample size and power. Statistical inference and hypothesis. Tests for statistical

significance: student t-test, Chi-square test, confidence level, Null hypothesis. (8 Hours)

Unit - 3

Linear regression and correlation. Analysis of Variance (one way and two way). Factorial designs

(including fraction factorial design). Theory of probability, Permutation and Combination, Ratios,

Percentage and Proportion. Two way ANOVA and Multiple comparison procedures. (8 Hours)

Unit - 4

Non-parametric tests, Experimental design in clinical trials, Statistical quality control, Validation, Optimization techniques and Screening design. Correlation and regression, least square method,

significance of coefficient of correlation, nonlinear regression. (8 Hours)

Unit - 5 Bioassays-calculations of doses response relationships, LD50, ED50. Applications of software for

statistical calculation viz. SPSS, foxtron. (8 Hours)

Recommended Books

1. Bolton, Pharmaceuticals Statistics- Practical & Clinical Applications, Marcel & Dekker, New

York. 2. Fisher, R.A., Statistical Methods for Research Works, Oliver & Boyd, Edinburgh.

3. Chow, Statistical Design and Analysis of Stability Studies, Marcel Dekker, New York.

4. Buncher, Statistics in the Pharmaceutical Industry, Marcel Dekker, New York.

5. Finney, D.J., Statistical Methods in Biological Assays, Hafner, New York.

6. Montgomery, D.C., Introduction to Statistical Quality Control, Willy.

7. Lipschutz, Introduction to Probability and Statistics, McGraw-Hill.

8. Li wan Po, Statistics for Pharmacist, Wiley-Blackwell.

* Latest editions of all the suggested books are recommended.


Semester I

PRODUCT DEVELOPMENT Course Code: MPU102 L-4, T-2, P-0, C-5

Objective: The basic objective of this course is to get familiar with product development.

Unit-1

PREFORMULATION STUDIES

Timings and goals of Preformulation. pre-formulation methodology, solid stat properties, partition coefficient, solubility, dissolution, crystal from the stability, compatibility tests, dissolution of drug

substances and dosage forms, Pediatric & geriatric aspects of formulation. (8 Hours)

Unit -2

PHARMACEUTICAL PROCESS VALIDATION

Regulatory basis, validation of sterile products, solid dosage forms, process. Drug additive

interaction. (8 Hours)

Unit-3

STABILITY

Theoretical considerations, Degradative pathways, Stability indicating assays, Influence of

packaging components on dosage form stability, Stabilization of Pharmaceutical formulations (solid,

liquid and semi solid formulations). (8 Hours)

Unit-4

Evaluation of Pharmaceutical formulations in vitro and in vivo studies and their correlation. Levels and types of IV-IVC. (8 Hours)

Unit -5

POLYMERS Types, Pharmaceutical Application, Molecular Weight Determination, Conformation of dissolved

linear macromolecules, Polymer solutions, Polymer in solid state, Fabrication.

PACKAGING DEVELOPMENT- Packaging materials, Types, Labeling, Preformulation screening

of packaging components. (8 Hours)

Recommended Books 1. Bannker G.S., & Rhodes C.T., Modern Pharmaceutics, Marcel Dekker, New York.

2. Liberman H.A. et al, Pharmaceutical Dosage Forms-Tablets, Marcel Dekker, New York.

3. Lachman L, Lieberman H.A. & Kanig J.L. The Theory & Practice of Industrial Pharmacy.

Varghese Publishing Home.

4. Aulton M.E., Pharmaceutics-The Science of Dosage form Design, Churchill Livingstone.

5. Liberman H.A. et al, Pharmaceutical Dosage Forms-Parenterals, Marcel Dekker, New York.

6. Carstensen J.T., Drug Stability-Principles & Practice, Marcel Dekker, New York.

7. Malmsten M., Surfactants and Polymers in Drug Delivery, Marcel Dekker, New York. 8. Ansel H.A. - Pharmaceutical Dosage Forms, Lippincott Williams & Wilkins.

9. Sarfaraz K. Niazi, Handbook of Preformulations: Chemical, Biological and Botanical Drugs,

CRC Press.

*Latest editions of all the suggested books are recommended


Semester I MODERN ANALYTICAL TECHNIQUE (MAT) LAB

Course Code: MPA151 L-0, T-0, P-8, C-4

Objective: The basic objective of this course is to get familiar with different analytical instruments.

Based on the Course Code: MPA101


Semester I

PRODUCT DEVELOPMENT LAB


Objective: The basic objective of this course is to get familiar with product development practicals.

Based on Course Code MPU103


Semester II

PHARMACEUTICAL PRODUCTION MANAGEMENT


Objective: The basic objective of this course is to get familiar with pharmaceutical production

management.

Unit-1 Status of Pharmaceutical industry with special reference to post GATT scenario.

Project planning and implementation.

Transfer of Technology. (8 Hours)

Unit-2

Master formula generation and SOP.

Pilot plant scale up techniques. (8 Hours)

Unit-3

Factory layout, Material Management: (8 Hours)

Unit-4 Process optimization and automation in pharmaceutical manufacturing. (8 Hours)

Unit-5

Inventory control. Different Systems of inventory control. Import and Export regulations laws and

methods to obtain I & E licenses, I and E regulations USA, EU and Japanese perspectives. (8 Hours)

Recommended Books

1. Banker G.S., & Rhodes C.T., Modern Pharmaceutics, Marcel Dekker, New York.

2. Remington, The Science & Practice of Pharmacy, Lippincott. William & Wilkins.

3. Lachman L, Lieberman H.A. & Kanig J.L., The Theory & Practice of Industrial Pharmacy,


4. Aulton M.E., Pharmaceutics – The Science of Dosage form Design, Churcill Livingstone.

5. Levin M.A., Pharmaceutical Process Scale up, Marcel Dekker, New York.

6. Dutta A.K., Material Management, Prentice Hall India.

7. Chary S.N., Production and Operative Management, Tata-Mcgraw Hill, India.

8. Kennedy T., Pharmaceutical Project Management, Marcel Dekker, New York.

* Latest editions of all the suggested books are recommended


Semester II

RECENT ADVANCES IN DRUG DELIVERY SYSTEM


Objective: The basic objective of this course is to get familiar with novel techniques and advances in

drug delivery system.

Unit-1

Formulation considerations with special emphasis on release patterns.

Sustained and Controlled release- oral, dental, nasal, ocular & parenteral systems. (8 Hours)

Unit-2

Fast Release- Introduction, formulation & evaluation. (8 Hours)

Unit-3 Transdermal Drugs Delivery System- Factors influencing transdermal delivery, formulation &

evaluation including Iontophoresis and Ionophoresis. (8 Hours)

Unit-4 Target Oriented Drug Delivery Systems- prodrugs, Liposome, Niosome, nanoparticles Microspheres and

microparticles. Lipoproteins Activated Carbons, Cellular Carriers, Antibodies, DNA, And Low

Molecular Weight Proteins.

Hormones, Dextran & Polysaccharides, Synthetic Polymers, Nanoparticles, Microparticles fabrication

techniques (Latest Advances). (8 Hours)

Unit-5

Nutraceuticals- introduction & scope. (8 Hours)

Recommended Books 1. Chien Y.W., Novel Drug Delivery Systems-Fundamentals, Developmental Concepts. Biomedical

Assessment, Marcel Dekker, New York.

2. Chien Y.W., ed., Transdermal Controlled Systemic Medications, Marcel Dekker, New York.

3. Schreyer, H., Drug Targeting Technology Physical, Chemical & Biological Methods, Marcel

Dekker, New York.

4. Banker G.S. & Rhodes C.T., Modern Pharmaceutics, Marcel Dekker, New York.

5. Gennaro A.R., Remington, The Science & Practice of Pharmacy, Lippincott. Williams & Wilkins.

6. Lachman L., Lieberman B.A & Kanig I.L., The Theory & Practice of Industrial Pharmacy,


7. Aulton M.E., Pharmaceutics-The Science of Dosage form Design, Churchill Livingstone.

8. Potts R.O. & Guy R.H., Mechanism of Trans dermal Drug Delivery, Marcel Dekker, New York.

* Latest editions of all the suggested books are recommended.


Semester II

BIO-PHARMACEUTICS & PHARMACOKINETICS

Course Code: MPU203 L- 4, T-2, P-0, C-5

Objective: The basic objective of this course is to get familiar with bio-pharmaceutics &

pharmacokinetics.

Unit-1

Drug Absorption Distribution & Disposition. (8 Hours)

Unit-2 Pharmacokinetics. Open one compartment, two compartment & three compartment models & their

limitations.

Non-compartmental pharmacokinetics. Graphical methods of calculating pharmacokinetic parameters.

(8 Hours)

Unit-3

Factors influencing bio-availability, evaluation of bioavailability, bio-equivalence with reference to

BCS. (8 Hours)

Unit-4

Dosage Regimens, Repetitive dosing and dose adjustments in renal and hepatic failure, individualization

of dosage regimen. (8 Hours)

Unit-5

Pharmacokinetic applications in Clinical practice. Principles of clinical trial. (8 Hours)

Recommended Books

1. Notari, R.E., Biopharmaceutics and Pharmacokinetics – An introduction, Marcel Dekker Inc. N.Y.

2. Rowland M., and Tozer T.N., Clinical Pharmacokinetics, Lea and Febriger, N.Y.

3. Wagner J.G., Fundamentals of Clinical Pharmacokinetics, Drugs Intelligence Publishers, Hamilton.

4. Wagner J.G., Pharmacokinetics for the Pharmaceutical Scientist, Technomic Publishing A.G. Basel,

Switzerland.


Semester II

RESEARCH PROJECT SYNOPSIS [Amended vide approval dated 17

th Nov 2012]

Course Code: MPU251 L-0, T-2, P-0, C-1 Objective: The basic objective of this course is to get familiar with the method, instrumentation and the

technology of the topic that is selected for the dissertation.

Guidelines:

1. The course will comprise of preparation of synopsis for the proposed research work to be done

during third and fourth semester courses.

2. The allotted supervisor will provide guidelines and determine the topic of the research work

based on thorough literature reviews.

3. The final presentation will be evaluated by the College CRC and the supervisor(s) based on the

quality of the work and its relevance in the pharmaceutical field.


EVALUATION SHEET

Name of Candidate:

Roll No:

Class and Section:

Please evaluate out of marks as indicated.

Subject Code:

Subject: RESEARCH PROJECT SYNOPSIS

Name of Candidate: Roll No:


S.N

o

Details Examiner I Examiner II Examiner III Average

Marks (25) Marks (25) Marks (25) Marks

(25)

Maximum marks in each column ( 5 marks x5) (5 marks x5) (5 marks x5)

1 OBJECTIVE IDENTIFIED & UNDERSTOOD

2

LITERATURE REVIEW / BACKGROUND

WORK

(Coverage, Organization, Critical review)

3 DISCUSSION/CONCLUSIONS

(Clarity, Exhaustiveness)

4 SLIDES/PRESENTATION SUBMITTED

(Readable, Adequate)

5

FREQUENCY OF INTERACTION ( Timely

submission, Interest shown, Depth,

Attitude)

Total

Signature with date

Signature and date of the Director/

Principal


Semester II

RECENT ADVANCES IN DRUG DELIVERY SYSTEM LAB

Course Code MPU252 L-0, T-0, P-8, C-4

Objective: The basic objective of this course is to get familiar with practicals related novel techniques

and advances in drug delivery system.

Based on the Course Code: MPU202


Semester II

BIO-PHARMACEUTICS & PHARMACOKINETICS LAB


Objective: The basic objective of this course is to get familiar with pharmacokinetic practicals.

Based on the Course Code: MPU203


Semester III

RESEARCH PROJECT (PHASE-I) [Amended vide approval dated 17

th Nov 2012]


Objective: The basic objective of this course is to represent the findings of the project that has been

done in the dissertation.

Guidelines: 1. The course will comprise of the confirmation of the proposed research work based on the initial

experimentation to confirm the feasibility of the work.

2. The allotted supervisor(s) will provide guidelines with exploration of the line of action with

recent trends of research in the related field and confirm global acceptability with regards to industry

and academic problems.

3. The continuous literature survey and modification of experimental pathway will be taken in to

practice with regular monitoring.

4. The candidate’s performance will be evaluated as follows:

There will be at least two seminars to be presented before the CRC during the semester consisting of the

progress of the research work. An end semester seminar will be held in the month of December/ January

under .The assessment will be 100 % internal the college committee will include at least following 3

members:-

• Seminar in-charge

• Supervisor

• Head of the department/ faculty member from the specialized field other than the supervisor

nominated by HOD

The information of the seminar will be given to the examination department. The examination

department may appoint an observer to the seminars from other college/ department with the approval of

the Vice Chancellor.

The marks will be forwarded to the University examination department immediately after the seminars.


Subject Code: Subject: RESEARCH PROJECT PHASE I



S.N

o


Marks (50) Marks (50) Marks 505) Marks

(50)

Maximum marks in each column (15 marks x5) (10 marks x5) (10 marks x5)


2


WORK






5



Attitude)

Total

Signature with date

Signature and date of the Director


Semester IV

RESEARCH PROJECT (PHASE –II)

(THESIS COMPILATION & VIVA-VOCE) [Amended vide approval dated 17

th Nov 2012]


Dissertation work

1. The student shall meet the guide frequently for the necessary guidance for the Thesis work.

2. During the semester as well as the semester break, student should read the literature germane to the

thesis topic. The progress of the Research / thesis work should continuously be informed to the guide.

3. In the end after necessary collection of data, literature survey and research work, the student must

prepare a thesis report (Final Report). The report shall be arranged and bind in the sequence consisting

of the following:-

Format of dissertation:

At the end of the IV semester the student will submit the dissertation based on the recommendation of

the student guide’s as per the format approved by the college.

The assessment will be 25% internal and 75% external


INTERNAL ASSESSMENT

Subject Code: Subject: RESEARCH PROJECT PHASE II



S.N

o


Marks (25) Marks (25) Marks (25) Marks

(25)

Maximum marks in each column ( 5 marks x5) (5 marks x5) (5 marks x5)


2


WORK






5



Attitude)

Total

Signature with date

Signature and date of the Director


EXTERNAL ASSESSMENT

Subject Code: Subject: RESEARCH PROJECT PHASE II


EVALUATION BY EXTERNAL EXAMINER

Roll

No

Student Name Criteria -1 Criteria -2 Criteria -3 Criteria -4 Criteria 5 Total

Marks (15) Marks (15) Marks (15) Marks (15) Marks (15) Marks

(75)

Criteria

No

Details of the criteria for evaluation


2 LITERATURE REVIEW / BACKGROUND WORK






5 FREQUENCY OF INTERACTION ( Timely submission, Interest shown, Depth, Attitude)

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