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M.PHARM SYLLABUS

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M.PHARM. INDUSTRIAL PHARMACY Courses of Study:

First Semester

MPIC 101: Instrumental methods of Analysis - Theory (Common to all Branches)

MPIC 102: Modern Analytical Techniques - Theory (Common to all Branches)

MPIC 103: Dosage Form Design Theory (Common with M.Pharm Quality Assurance and M.Pharm Industrial Pharmacognosy)

MPIC 104: Modern Pharmaceutics- Theory (Common with M.Pharm Quality Assurance)

MPIC 105: Quality Assurance Management Theory (Common with M.Pharm Quality Assurance)

MPIP 106: Pharmaceutical Analysis Practical (Common to all Branches)

MPIP 107: Industrial Pharmacy Practical (Common with M.Pharm Quality Assurance)

Second Semester

MPIC 201: Biopharmaceutics - Theory (Common with M. Pharm. Pharmacy Practice and M.Pharm Pharmacology)

MPIC 202: Clinical Pharmacokinetics - Theory (Common with M. Pharm. Pharmacy Practice and M.Pharm Pharmacology)

MPIC 203: Advances in Drug Delivery Systems Theory

MPIC 204: Advanced Pharmaceutics Theory

MPIC 205: Pharmaceutical Production Management Theory

MPIP 206: Biopharmaceutics Practical (Common with M. Pharm. Pharmacy Practice)

MPIP 207: Advanced Industrial Pharmacy Practical

Third Semester

MPIC 301: Research methodology and Pharmaceutical Statistics - Theory

MPIC 302: Elective:

1. MPIE 302(1) Advances in Industrial Pharmacy Theory 2. MPIE 302(2) Pharmaceutical Healthcare Theory 3. MPIE 302(3) Analytical method development Theory 4. MPIE 302 (4) Clinical pharmacology - Theory 5. MPIE 302(5) Strategy In Drug Synthesis - Theory 6. MPIE 302(6) Pharmacobiotechnology - Theory

MPIT 303: Thesis Phase I

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Fourth Semester MPIT 401: Thesis Phase II

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Scheme of Examinations

M.Pharm. - Industrial Pharmacy

Subject Hrs/Week Credits Evaluation (Marks) L T P sessional Univ.

Exam Total

I-Semester MPIC 101 Instrumental methods of

Analysis Theory 2 1 -- 3 25 75 100

MPIC 102 Modern Analytical Techniques Theory 2 1 -- 3 25 75 100

MPIC 103 Dosage Form Design Theory 2 1 -- 3 25 75 100

MPIC 104 Modern Pharmaceutics- Theory 2 1 -- 3 25 75 100

MPIC 105 Quality Assurance Management Theory 2 1 -- 3 25 75 100

MPIP 106 Pharmaceutical Analysis Practical -- -- 4 2 40 60 100

MPIP 107 Industrial Pharmacy Practical -- -- 6 3 40 60 100

II-Semester MPIC 201 Biopharmaceutics - Theory

2 1 -- 3 25 75 100

MPIC 202 Clinical Pharmacokinetics Theory 2 1 -- 3 25 75 100

MPIC 203 Advances in Drug Delivery Systems Theory 2 1 -- 3 25 75 100

MPIC 204: Advanced Pharmaceutics Theory 2 1 -- 3 25 75 100

MPIC 205 Pharmaceutical Production Management Theory 2 1 -- 3 25 75 100

MPIP 206 Biopharmaceutics Practical -- -- 4 2 40 60 100 MPIP 207 Advanced Industrial

Pharmacy Practical -- -- 6 3 40 60 100

III -Semester MPIC 301 Research Methodology &

Pharmaceutical Statistics 2 1 -- 3 25 75 100

MPIE 302 Elective 2 1 -- 3 25 75 100 MPIT 303 Thesis Phase I 15 6 40 60 100

IV- Semester MPIT 401 Thesis Phase II

13 40 60 100

Syllabus

FIRST SEMESTER

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MPIC 101: INSTRUMENTAL METHODS OF ANALYSIS (Theory) 35 Hrs.

1. UV-Visible Spectrophotometry: Theory Beer and Lambert - Limitations of the law, Design and working of single beam and double beam spectrophotometers. Applications of UV absorptions spectrophotometry in qualitative analysis and quantitative analysis.

2. Fluorimetry: Theory - Photoluminescence Fluorescence and Phosphorescence. Chemical structure and fluorescence - factors affecting fluorescence intensity. Instrumentation and Pharmaceutical applications of fluorimetry.

3. Flame Photometry and Atomic Absorption Spectrophotometry: Theory, Instrumentation Types of interference and elimination of interference - Pharmaceutical applications

4. Chromatography: Principle, technique and applications of HPTLC, Gel filtration, Ion exchange chromatography and super critical fluid chromatography.

5. Chromatography: HPLC, GC, Plate theory, Van Deempter equation - Principle, Instruments and application. Chromatographic attributes: Capacity factor, resolution, theoretical plates and symmetry factor

6. Preliminary studies on X-Ray Diffraction and Inductively coupled plasma mass spectrometry

7. Introduction to Radio Immuno Assay

Books for Reference:

1. GN. Jeffery, Jbassett, J. Mendham and R.C. Denney, (ed), Vogels textbooks of quantitative inorganic analysis, ELBS, London.

2. A.H. Beckett and J.B. Stenlake, Practical pharmaceutical chemistry, part I and II, the Athlone Press London.

3. D.A. Skoog, D.M., West and F.J. Holler Fundamentals of Analytical Chemistry, Saunders College publishing, New York.

4. D.A. Skoog and J.J Leary Principles of Instrumental Analysis, Saunders college publishing, New York.

5. H.H Willard, L.L. Meritt, J.A. Dean and F.A. Settle, Instrumental methods of Analysis, Wadsworth, New York.

6. V.K. Srivastava and K.K. Srivastav, Introduction to Chromatography, S. Chand & Company, New Delhi.

7. H. Strobel and W.R. Heinemann Chemical Instrumentation, Addition-Wisely, Boston.

8. John R. Dyer, Applications of absorption Spectroscopy of Organic Compounds, Prentice Hall London.

9. Robert M. Silverstein, Clayton Bassler and Terence C. Morril, Spectrophotometric Identification of organic Compounds, John Wiley & Sons, New York.

10. Y.H. Sharma, Elementary Organic Absorption Spectroscopy, S. Chand & Co., New Delhi.

11. Undenfriend S., Florescence in biology and Medicine, Academic Press , New York.

12.London.

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13. Pharmacopoeia of India, Govt. of India, Ministry of Health.

14. British Pharmacopoeia, ministry of Health and Social Welfare, UK.

15. United States Pharmacopoeia, US Pharmacopoeia Convention Inc. Rockville, USA.

16. A.K. Srivastava, P.C. Jain Chemical Analysis, S. Chand & Company Ltd., New Delhi.

17. Robet V. Smith, James T. Stewart, text books of Biopharmaceutical Analysis, Lea & Febiger, Philadelphia.

MPIC 102: MODERN ANALYTICAL TECHNIQUES (Theory) 35 Hrs.

1. IR-Spectrophotometry: Theory, molecular vibration, instrumentation sample preparation - application of IR spectrophotometry in pharmacy. Introduction to FTIR

2. NMR-Spectrometry: Theory and instrumentation spin-spin coupling, chemical shift, magnetic equivalence spin-spin decoupling shift reagents, applications of NMR spectrometry in pharmacy and interpretation of NMR spectra (using spectra of simple organic compound as example)

3. Mass Spectrometry: Theory, fragmentation pattern, ionization techniques: electron bombardment, chemical ionization, field desorption, fast atom bombardment. Different analysers. Interpretation of mass spectra, determination of molecular weight and molecular formula and applications of mass spectrometry

4. Theory, instrumentation and applications of Differential Thermal Analysis and Differential Scanning Calorimetry.

5. A preliminary study of principle, Instrument and applications of 13C NMR

6. Introduction to Bio Assay- bio assay of Insulin Microbiological assay of Vitamins & antibiotics

Books for reference:

1. A.H. Beckett and J.B. Stenlake, Practical pharmaceutical chemistry, part I and II, the Athlone Press London.

2. D.A. Skoog and Leary J.J., Principles of Instrumental Analysis, Saunders college publishing, New York.

3. H.H Willard, L.L. Meritt, J.A. Dean and F.A. Settle, Instrumental methods of Analysis, Wadsworth, New York.

4. H. Strobel and W.R. Heinemann Chemical Instrumentation, Addition-Wisely, Boston.

5. John R. Dyer, Applications of absorption Spectroscopy of Organic Compounds, Prentice Hall London.

6. Robert M. Silverstein, Clayton Bassler and Terence C. Morril, Spectrophotometric Identification of organic Compounds, John Wiley & Sons, New York.

7. Y.H. Sharma, Elementary Organic Absorption Spectroscopy, S. Chand & Co., New Delhi.

8. Barrow, G.M., Introduction to molecular spectroscopy, McGraw-Hill. London.

9. Haris, R.K. Nuclear Magnetic Resonance Spectroscopy, Pitman, London.

10. A.K. Srivastava, P.C. Jain Chemical Analysis, S. Chand & Company Ltd., New Delhi.

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MPIC 103: DOSAGE FORM DESIGN (Theory) 35 Hrs.

1. Manufacturing and Quality control of solid dosage forms: Tablets and Capsules. 2. Manufacturing and Quality control of liquid dosage forms: orals and topicals. 3. a) Parenterals formulation development and evaluation b) Aerosol Formulation Development and its Quality Control 4. Radio pharmaceuticals: Background information, dosage formulation, diagnostic and therapeutic

uses, production, quality assurance, storage and safety hazards. 5. Selection and evaluation of packaging materials, containers and closures, special problems of

container product interactions. Pharmacopoeial specifications, tests and standards for packaging materials.


1. Gennaro A R, Remington: The Science and Practice of Pharmacy, 20th Edn.,Vol I & II, Lippincott Williams & Willkins, Philadelphia, PA, 2000.

2. Lachman L & Liberman H A, The Theory and Practice of Industrial Pharmacy, 3rd Edn, Vergese Publishing House, Mumbai, 1991.

3. Banker G S and Rhodes C T, Modern Pharmaceutics, 3rd Edn., Marcel Dekker, Inc., New York, 1995

4. Lachman L, et al, Pharmaceutical Dosage Forms: Parenteral Medications, 2nd Edn., Vol I & II, Marcel Dekker, New York, 1992.

5. Lachman L, et al, Pharmaceutical Dosage Forms: Tablets, 2nd Edn., Vol I, II & III, Marcel Dekker, New York, 1992.

6. Turco S and King R E, Sterile Dosage Forms, 3rd Edn., Lea & Febiger, Philadelphia, 1987. 7. Aulton M E., Pharmaceutics The Science of Dosage Form Design, 1st (International Student)

Edn., Churchill Livingstone, New York, 1996.

MPIC 104: MODERN PHARMACEUTICS (Theory) 35 Hrs.1. Stability testing of Pharmaceutical products: Physico-chemical factors affecting stability of drugs,

methods to find out degradation pathways, determination of shelf life by accelerated stability testing.

2. Incompatibilities encountered in multi-component drug formulations, rationale for drug

3. Enzyme Technology-Production, Isolation and purification of Enzymes, applications in pharmacy and Immobilised Enzymes and its future applications.

4. Sterile dosage forms: biologicals 5. Products of Biotechnology. Principles of Genetic Engineering.

Books for Reference: 1. Gennaro A R, Remington: The Science and Practice of Pharmacy, 20th Edn.,Vol I & II, Lippincott

Williams & Willkins, Philadelphia, PA, 2000. 2. Lachman L & Liberman H A, The Theory and Practice of Industrial Pharmacy, 3rd Edn, Vergese

Publishing House, Mumbai, 1991.

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3. Banker G S and Rhodes C T, Modern Pharmaceutics, 3rd Edn., Mercel Dekker, Inc., New York, 1995

4. Turco S and King R E, Sterile Dosage Forms, 3rd Edn., Lea & Febiger, Philadelphia, 1987. 5. Aulton M E., Pharmaceutics The Science of Dosage Form Design, 1st (International Student)

Edn., Churchill Livingstone, New York, 1996. 6. Wiseman A, Principles of Bio-Technology, 2nd Edn., Surrey Univ. Press, New York, 1988. 7. Ansel H C, Allen, Jr., L V et al, Pharmaceutical Dosage Forms and Drug Delivery Systems, 7th

Edn., Lippincott Williams & Wilkins, Philadelphia, PA, 2000.

8. Wiseman A, Handbook of Enzyme Biotechnology, 2nd Edn., Ellis Horwood Ltd., New York, 1985.

MPIC 105: QUALITY ASSURANCE MANAGEMENT (Theory) 35 Hrs.

1. The origin and concept of GMP Schedule M of Drugs and cosmetics Act, WHO specifications and US FDA guidelines. The study shall include special emphasis on premises, personnel, sanitation, equipment, manufacturing operation and documentation. GMP certification.

2. Regulatory affairs D&C act, DPCO

3. Ware housing Design, Construction, maintenance and sanitation for materials and products good warehousing practices.

4. Finished product release, Quality review, Quality audits Batch release Distribution and Distribution records Handling of returned goods. Recovered materials and reprocessing.

5. Complaints and recalls, evaluation of complaints and recall procedures.

6. Documentation relating to product development, standard operating procedures, standard test processes, cleaning methods, Quality control documents, batch release document, distribution records, complaints and recalls records, retention of records.

7. Intellectual property rights and Patent Laws


1. Theory and Practice of Industrial Pharmacy by Liberman and Lachman. 2. 3. GMP by Sidney H, Willing. 4. Quality Assurance Guide, Organization of Pharmaceutical Production of India. 5. Drugs and Cosmetics Act 1940 and Rules 1945 6. S.H. Willig., M.M.T. Tuckerman, W.S. Hitchings IV, Good Manufacturing Practices for

Pharmaceuticals, Marcel Dekker Inc, New York. 7. , Vandhana Publication, Agra. 8. Ira R. Berry and R.A Nash (eds), Pharmaceutical Process Validation, marcel Dekker Inc., New

York.

MPIP 106: PHARMACEUTLICAL ANALYSIS (Practical) 45 Hrs.

1. Experiments based on theory subjects Instrumental methods of analysis and Modern Analytical techniques

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2. Experiments would be selected illustrating the principles involved in estimation of raw materials and finished products representing major categories of drug formulations from pharmacopoeias.

MPIP 107: INDUSTRIAL PHARMACY (Practical) 70 Hrs.

1. Experiments based on Dosage Form Design and Modern Pharmaceutics theory papers would be selected for the practical.

SECOND SEMESTER

MPIC 201: BIOPHARMACEUTICS (Theory) 35 Hrs.

1. Drug absorption and disposition: Mechanism of drug transport, factors affecting absorption, distribution, biotransformation and elimination.

2. First order process, rate constants, half-life; Zero order process

3. Open one compartment model: Description, volume of distribution, drug concentration in plasma, kinetics of I.V. administration, short term constant rate I .V. infusion, absorption rate and drug effects , continuous constant rate infusion, repetitive dosing- average concentration of drug at steady state , loading dose , dosing interval.

4. Open two-compartment model; Kinetics of absorption, distribution and elimination. Multiple dose administration. Limitation of multi- compartmental analysis.

5. Non-compartmental model; Area under first moment curve (AUMC), Apparent volume of distribution, mean residence time (MRT), Drug absorption predicting steady state concentration.



2. Gibaldi M, Bio-Pharmaceutics and Clinical Pharmacokinetics, 4th edn., Lea and Febiger, Philadelphia, 1991.

3. Notari R E, Bio-Pharmaceutics and Clinical Pharmacokinetics, 4th Edn., Marcel Dekker, Inc., New York, 1987.

4. Brahmankar and Jaiswal, Bio- Pharmaceutics and Pharmacokinetics A Treatise, 2nd Edn., Vallabh Prakashan, New Delhi, 1998.

5. Swarbrick J, Current Concept in Phramaceutical Science: Bio Pharmaceutics, Lea & Febiger, Philadelphia, 1970.

MPIC 202: CLINICAL PHARMACOKINETICS (Theory) 35 Hrs.

1. Clearance concepts- organ clearance, total clearance, renal clearance and excretion.

2. Hepatic clearance and elimination, other non renal clearance. Extraction ratio

3. Bio-availability and bio equivalency testing; Estimation methods, dissolution testing, in vitro & in vivo correlation study , bio equivalency testing of dosage forms.

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4. Pharmacokinetic variability; Body weight & size, obesity, age. Drug metabolism, Plasma protein binding and renal excretion in newborn & children. Sex, pregnancy and genetic factors. Poly morphic acetylation and oxidation.

5. Pharmcokinetic variability: Drug interactions

6. Effect of disease states on drug disposition, therapeutic drug monitoring and dosage prediction of digoxin, gentamycin and anticonvulsants. Hypothesis of individualisation & optimisation of drug therapy.



2. Gibaldi M, Bio-Pharmaceutics and Clinical Pharmacokinetics, 4th edn., Lea and Febiger, Philadelphia, 1991.

3. Notari R E, Bio-Pharmaceutics and Clinical Pharmacokinetics, 4th Edn., Marcel Dekker, Inc., New York, 1987.

4. Brahmankar and Jaiswal, Bio- Pharmaceutics and Pharmacokinetics, 2nd Edn., Vallabh Prakashan, New Delhi, 1998.

5. Wagner J G, Bio- Pharmaceutics and relevant Pharmacokinetics, Drug Intelligence Publications, Washington DC, 1971.

6. Rowland M and Tozer TN, Clinical Pharmacokinetics concepts and applications, 3rd Edn., Lea & Febiger, Philadelphia, 1995.

7. Shargel L and Yu AB, Applied Bio-Pharmaceutics and Pharmacokinetics, Appleton & Lange, Norwalk, CT, 1993.

MPIC 203: ADVANCES IN DRUG DELIVERY SYSTEM (Theory) 35 Hrs.

1. Sustained Release Drug Delivery System Concept, drug properties relevant to sustained release formulation, mechanisms, oral and parental sustained release dosage forms and their Evaluation.

2. Targeted Drug Delivery System nanoparticles, liposomes, resealed erythrocytes, immunologically based system antibodies for drug delivery, magnetic micro spheres.

3. Controlled Drug Delivery Modules (a) Insulin pump, Occusert, Oral osmotic pump system, Modules for gastrointestinal tract, Implants, Intra vaginal & intra uterine drug delivery systems (b) Transdermal drug delivery systems

4. Delivery of biotechnology products; Genetic material drug delivery, protein and peptide drug delivery.

5. Regulatory considerations in controlled release medication requirements to demonstrate safety and efficacy and controlled release nature, pharmacokinetic consideration and bioavailability assurance. Feasibility of manufacture of sustained action drug delivery systems.



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2. Banker G S and Rhodes C T, Modern Pharmaceutics, 3rd Edn., Mercel Dekker, Inc., New York, 1995

3. Aulton M E., Pharmaceutics The Science of Dosage Form Design, 1st (International Student) Edn., Churchill Livingstone, New York, 1996.

4. Ansel H C, Allen, Jr., L V et al, Pharmaceutical Dosage Forms and Drug Delivery Systems, 7th

Edn., Lippincott Williams & Wilkins, Philadelphia, PA, 2000.

5. Chien Y W, Novel Drug Delivery Systems, 2nd Edn., Marcel Dekker, Inc., New York, 1992.

6. Robinson J R and Lee V H, Controlled Drug Delivery System Fundamentals and apllications, 2nd Edn., Marcel Dekker, Inc., New York, 1987.

7. Tyle P, Drug Delivery Devices, Fundamentals and Applications, Marcel dekker, Inc., New York, 1988.

MPIC 204: Advanced Pharmaceutics Theory 35 Hours

Fundamentals of drug nanoparticle: Nanoparticle size, nanoparticle surface, Nanoparticle suspension and settling, production of nanoparticles, biological transport of nanoparticle. Types of nanoparticular drug delivery system.

Manufacture of nanoparticle: Pearl / Ball milling, high pressure homogenisation, spray drying, pellatisation techniques, super critical fluid technique, polymer stabilised nanoparticle. Characterisation & evaluation of nanoparticles.

1. Bioequivalence testing : Methods for determining bioequivalence; Minimizing the need for bioequivalence studies; Evaluation of bioequivalence data; Bioequivalence assessment and data evaluation; Criteria for bioequivalence and statistical requirements; Average or individual bioequivalence.

2. Plastic packaging materials: Types: Thermoplastics and Thermosets; commonly used thermoplastics and thermosetting plastics and their applications including blister packaging; Biological and physicochemical testing procedures; Regulatory aspects; Recent trends.

3. Coating of pharmaceutical dosage forms: Objectives of coating; Film coating of solid dosage forms film coating materials; Modified release film coatings- enteric and sustained release coatings; Coating equipments; compresson coating; Recent trends

4. Statistical methods in dissolution studies: Biopharmaceutical Classification System (BCS) of solid drugs; Application of BCS classification in oral drug delivery; Dissolution profile comparisons; Statistical evaluation of dissolution similarity- difference factor(f1) and similarity factor (f2); Statistical properties of the dissolution test.

5. (a) Drug release mechanisms and kinetics- Robinson Eriksen equation, Higuchi equation in the design of modified release dosage form total dose calculation; Korsemeyer-Peppas mathematical model and mode of drug release elucidation.

(b) Novel delivery of drugs through Nano/Micro-Electro Mechanical System (NEMS/ MEMS) and Gastro-retentive approach.

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Reference Books

1. Gupta R.B., Kompella UB., Nonoparticle technology for drug delivery, Taylor & Francis, New York, 2006 (Chapter 1)

2. Allen Jr. LV. Remington: The science and practice of pharmacy, 22nd Edn. Lippincott Williams & Wilkins, Philadelphia, 2010.

3.systems, 9th Edn., Lippincott Williams & Wilkins, Philadelphia, 2009.

4. Aulton ME. Ault 3rd Edn, Churchill Livingstone, New York, 2007

5. Lachman L, Lieberman HH and Kanig, JL. The theory and practice of industrial pharmacy, 3rd Edn., Lea & Febiger, Malvern, Pa, 1986

6. Guidance for Industry- Dissolution testing of immediate release solid oral dosage form. FDA, US, Centre for Drug Evaluation and Research (CDER), Aug 1997.

7. Indian Pharmacopoeia-2007, the Indian Pharmacopoeia commission, Ghaziabad.

8. British Pharmacopoeia-2011, the Stationery office, London.

9. United States Pharmacopoeia-2008, USP 31, NF 26 the United States Pharmacopoeial convention, 12601, Twin brook pathway, Rockvilli, MD 20852.

MPIC 205: PHARMACEUTICAL PRODUCTION MANAGEMENT (Theory) 35 Hrs.

1. Lay out of building, material management, Production planning and control, sales forecasting.

2. New Product development Market research, Project identification, Management and Production lunch.

3. ISO 9000 Salient features. Drug regulatory affairs Drugs and Cosmetics Act, Drugs (Price Control) Order, Essential Commodities Act.

4. Safety and environment management.

5. Human resource management Supervisory skills and communication skills. 6. US-FDA regulatory affairs: US FDA review process for Investigational New Drug (IND), New Drug

(NDA). Hatch Waxman amendment, Abbreviated New Drug Application (ANDA) for generic market - types of ANDA - Data presentation - verification and grant by FDA - Common Technical Documentation (CTD), and review process. Drug master File (DMF), Type - filing process - benefits. New product exclusivity patent term restoration - exclusivity and orange book listings

federal register

7. GMP certification as per WHO: need and procedure for certification

Books for Reference: 1. Gennaro A R, Remington: The Science and Practice of Pharmacy, 20th Edn.,Vol I & II, Lippincott

Williams & Willkins, Philadelphia, PA, 2000.

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2. Lachman L & Liberman H A, The Theory and Practice of Industrial Pharmacy, 3rd Edn, Vergese Publishing House, Mumbai, 1991.

3. Drugs and Cosmetics Act, 1940 and the rules there under, 1945, Government of India.

4. Drugs Price Control Order, 1995, Ministry of Health, Govt. of India.

5. Sharma PP, How to Practice GMP, 1st Edn., New Delhi, 1998.

6. ISO Standards, Bureau of Indian Standard, New Delhi.

7. Pestomji, Text Book of Personal Management

8. Rao V Subba, Text Book on Personal Management, Panther, New Delhi, 1994.

MPIP 206: BIOPHARMACEUTICS (Practical) 45 Hrs.

1. Experiments based on Biopharmaceutics theory would be selected for the practical.

MPIP 207: ADVANCED INDUSTRIAL PHARMACY (Practical) 70 Hrs.

1. Experiments would be selected based on Pharmacokinetics, and Advanced Drug Delivery system, theory courses

THIRD SEMESTER MPIC 301: RESEACH METHODOLOGY AND PHARMACEUTICAL STATISTICS (Theory) 35 Hrs.

[Student should be familiar with pharmaceutical/chemical applications and use statistical tools, by way of calculations, but not expected to derive and find proof.]

1. Writing of articles, thesis scientific writing, preparing title, abstracts; organization of thesis and conventions adopted in writing; citing references; preparation of oral, poster presentation. Accessing required information in a systematic manner from abstracts, books journals, conference proceedings, thesis and dissertations, internet, CDROM etc. Ethics, rights, permissions

2. The Population - The sample; measures describing the center of data distributions; measurement of spread of data. Introduction to Probability - The Binomial and Normal distributions - their significance.

3. Statistical inference: -Statistical estimation (confidence intervals) - Hypothesis testing - t tests, F tests, ANOVA [one way], Chi square test.

4. Linear regression and correlation. 5. Control charts Constructing control charts, between batch variation as a measure of variability,

quality control charts in research and development, quality control charts for proportions. 6. Non parametric methods 7. Data characteristics suitable to non parametric procedures; Sign test, Wilcoxon signed rank test;

Wilcoxon rank sum test; kruskal Wallis test[one way ANOVA]; Runs test for randomness; Contingency tables.

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References:

1. Pharmaceutical Statistics, 2nd Ed., Sanford Bolton, Dekker series. 2. How to write and publish a scientific paper, 4th Ed., Robert A Day Cambridge University

presses. 3. Fundamentals of Analytical Chemistry 7th Ed., Skoog, West, Holler Saunders College

Publishing.

MPIE 302(1) ADVANCES IN INDUSTRIAL PHARMACY (Theory) 35 Hrs

1. Pre formulation studies and new formulation development.

2. New drug development and approval process: Investigational New Drugs (IND), New Drug Application ( NDA ), Supplemental New Drug Application ( SNDA ) , ICH requirements for registration of pharmaceuticals.

3. Validation techniques.

4. Methods of enhancing bioavailability, solubilisation, pro drugs, enhancement of dissolution characteristics, bioavailability enhancers.

5. Pharmaceutical product stability testing- ICH guidelines.

6. Polymers: Pharmaceutical applications, molecular weight, conformation, polymer solution, gel formation, coacervation, phase separation, microencapsulation, mechanical properties, biomedical uses of polymers.


1. Gennaro A R, Remington, The Science and Practice of Pharmacy, 20th Ed.,Vol I & II, Lippincott Williams & Willkins, Philadelphia, PA, 2000.

2. Lachman L & Liberman H A, The theory and Practice of Industrial Pharmacy, 3rd Ed., Vergese Publishing House, Mumbai, 1991.

3. Banker G S and Rhodes C T, Modern Pharmaceutics, 3rd Ed., Marcel Dekker, Inc., New York, 1995.

4. Aulton M E., Pharmaceutics The Science of Dosage Form Design, 1st (International Student) Ed., Churchill Livingstone, New York, 1996.

5. Ansel H C, Allen, Jr., L V et al, Pharmaceutical Dosage Forms and Drug Delivery Systems, 7th Ed., Lippincott Williams & Wilkins, Philadelphia, PA, 2000.

6. FDA Code of Federal Regulations, Title 21, Part 300 314.

7. Guarino, R A, New Drug Approval Process, Marcel Dekker, Inc., New York, 1987.

8. Martin A et al, Physical Pharmacy, Indian Ed., New Delhi, 1998.

MPIE 302(2) PHARMACEUTICAL HEALTH CARE - THEORY 35 Hrs.

1. Concept and necessity of Pharmaceutical Health care. 2. A rational approach in paediatrics and geriatric care. 3. Therapeutic consideration with rational approach during pregnancy and lactation. 4. Evaluation of Immune system and its fuctions.

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5. Rational use of antimicrobials. 6. Assessment and clinical significance of malnutrition, enteral and parentral nutrition, Nutritional

consideration in major organ failure. 7. Standard treatment protocols of the following diseases Hypertention, Diabetes mellitus, Peptic

Ulcer, Diarrhoea, Urinary tract infection, Bronchitis, Asthma. 8. Self care: Constipation, Common cold, cough, pain, and sun light protection.

REFERENCES :

1. Drug Treatment Protocols, Edited by Damil H.Albert, 2nd Ed., American Pharmaceutical Association, Washington.

2. Role of Pharmacist in the health care system , WHO / PHARM / 94. 569

3. Handbook of Nonprescription Drugs, American Pharmaceutical Association, 12th Ed., 1996.

4. Standard Treatment Guidelines

a) by WHO b) by Government of India c) by Various state governments

MPIE 302(3) ANALYTICAL METHOD DEVELOPMENT THEORY 35 HRS.

1. Errors in Analysis: Accuracy (absolute method, comparative method); Precision; classification of errors, estimation of errors, sources of errors, minimization of errors, normal distribution of errors. Significant figures in analytical chemistry rules and computations.

2. Calibrations, Standardisations: Calibrating signals, apparatuses; calibration curves external standard methods, internal standard method, standard addition method [applications in HPLC and GLC with calculations], linear regression of straight line calibration curves using the regression equation [applications and calculations].

3. Obtaining and Preparing Samples For Analysis: Importance of sampling techniques sampling techniques random, stratified, systematic, cluster, for quality control. Sample preparation reducing particle size, making solutions, separating analyte from interferants extraction, automated extraction, solid phase extraction, solid phase micro extraction, super critical fluid extraction and micro wave assisted extraction.

4. Validating the analytical method including bio-analytical method: Need for validation; historical background; validation of analytical procedures-- methodology guidelines of ICH; FDA; USP. Understanding of the following concepts in validation accuracy, precision, specificity, limit of detection, limit of quantification, blind analysis of standard sample, ruggedness testing, robustness testing, equivalency testing. Validating the method as standard method collaborative test two sample collaborative testing, control charts.

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5. Development of HPLC method: Selection of tools: Choice of HPLC mode, Column, Mobile phase, Special additives. Method Development guiding tools: Separation factor, Selectivity factor, Resolution, Tailing factor. Controlling selectivity: Solvent: Organic phase, Aqueous phase, Additional Variables: pH, Stationary Phase, Temperature. Column Conditions: Flow, Column dimension, Particle diameter. Derivatisation.

6. System suitability tests as per Pharmacoepoeial specification.

7. Development of stability indicating analytical method

Books for References:

1. HPLC method development, Lunn. G(1996),John wiley & Interscience.

2. Pharmacopoeia of India, 4th Ed. (1996), Govt.of India, Ministry of Health and Family Welfare.

3. British Pharmacopeia (1993) London, 4. ICH guide lines: validation of analytical procedures, methodology, November 1996.

5. th Ed.

6. Pharmaceutical process validation II Ed., Ira R berry, Robert a Nash; Marcel Decker series, 1993.

7. Pharmaceutical statistics II Ed., Sanford Bolton, Decker series, Newyork and Basel.

8. Fundamentals of analytical chemistry 7th Ed.; Skoog, West, Holler, Saunders college publishing.

MPIE 302(4): CLINICAL PHARMACOLOGY -THEORY (35 Hrs)

1. (a) Definition and scope of clinical pharmacology, measurement of drug response in man.

(b) Clinical trails- Phase I, Phase II , Phase III and post marketing surveillance data analysis & presentation skills

(c) Pharmaco- epidemiology.

2 (a) Drug Drug interaction, Drug food interaction, and Drug disease interaction in clinical pharmacology.

(b) Adverse drug reactions and ADR monitoring.

3 (a) Essential drug list, national drug policy

(b) Orphans drugs

vension in Therapeutic drug monitoring in special situations such as pediatrics, geriatric and pregnant cases.


1. Goodman and Gil Pharmacological Basis of Therapeutic 9th Ed.

2. Pharmacology, by H.P.Rang and M.M. Dale 3rd Ed.

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3. th Ed.

4. Evaluation of drug activities pharmacometrics by D.R.Laurence and A.L.Bachanarach Vol 1. and 2

5. Modern Drug Research Paths to better and safe drugs by Y.C.Martin, E.Kutter and V.Austel

6. Practical approach in toxicity studies by pooley and leslie

7. Screeining methods in Pharmacology by R.A.Tuner

8. Clinical Pharmacology by D.R.Laurence and P.N.Bennett

9. Methods of clinical drug trials by Aln Sperit and Smion

10. Alternatives to animal experiments: Developing in-vitro methods and changing legislation. TIPS., 11:1990 104-107

11. Alternatives to animals in toxicity testing. Scientific American., 261(1989): 16-22

12. Clinical drug trial and tribulations by Allan E.Cato (1980).

13. The Oxford text book of Clinical Pharmacology and drug therapy by D.G.Grehame-Smith and J.K.Aronson.

14. International aspects of drug evaluation and usage by Jouhar and Grayson.

MPIE 302(5): STRATEGY IN DRUG SYNTHESIS Theory 35 Hrs. 1. Organic Name Reaction :

Aldol Condensation, Arndt-Eistert Synthesis, Bayer-Villiger rearrangement, Beckmann rearrangement, Cannizaro reaction, Claisen condensation, Claisen rearrangement, Curtius rearrangement, Diels-Alder reaction, Favoriskii rearrangement, Fries rearrangement, Hoffman rearrangement, Pinacol rearrangement, Mannich reaction, Perkin reaction, Reformatsky reaction, Scmidt rearrangement.

2. Introduction: Basic rules in disconnection. 3. Application of Synthon approach to drug synthesis: Case Studies.

a. Antihistaminic agents: Promethazine, Cyclizine, Diphenhydramine. b. Adrenergic agents: Stimulants, Epinephrine, Ephedrine. c. Adrenergic blocking agents: Propranolol, Guanethidine. d. Psychotropic agents: Chlorpromazine, Chloprothixene. e. Antidepresants: Imipiramine. f. CNS Stimulants: Amphetamine. g. Narcotic analgesics: Meperidine, Methadone, Propoxyphene.


1. Organic Chemistry, Morrison and Boyd, Prentice Hall Pvt. Ltd., New Delhi.

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2. Advanced Organic Chemistry, Jerry March, Mc-Graw-Hill.

3. Solomons Organic chemistry 5th Ed.

4. Organic Chemistry, I.L. Finar Vol. I, ELBS.

5. Modern Synthetic reaction, H.O.House.

6. Some Modern Method of Organic Synthesis, W. Carruthers.

7. Designing organic synthesis with work book a programmed introduction to the synthon approach, Stuart Warren.

MPIE-302(6): PHARMACOBIOTECHNOLOGY (Theory) 35 Hrs.

1. Fermentation (Microbial biotechnology): Introduction and scope, Fermentation process. Types of Fermentation processes: Batch culture, Continous culture, Fed-batch culture, Cascade fermentation. Upstream processes, Fermentation process, Monitoring microbial growth, Down stream processing, Microbial products, Improvements in microbial strains. Production of Riboflavine, Ascorbic acid, Fungal amylases, Citric acid, L-Glutamic acid and Penicillin.

2. Enzyme Biotechnology: Introduction, Properties and charateristics of enzymes. Basic nomenclature of enzymes. Factors influencing enzyme action. Sources of enzymes. Methods of enzyme production. Profile of some important enzymes: Hyaluronidase, Penicillinase, Streptokinase, Amylases, Protease. Enzyme Immobilization: Carrier matrices, Materials and Methods of immobilization (Adsorption method, Covalent bonding, Entrapment, Encapsulation). Advantages and disadvantages of immobilization. Application of Enzymes and Immobilized enzymes.

3. Plant Tissue Culture Technology: Introduction and scope. Princple underlying plant culture (totipotency). Nutrient media composition and preparation. Role of plant growth regulators in Cell culture. Laboratory requirements for plant tissue culture. Aseptic techniques and Maintenance of Aseptic environment. Basic steps in plant tissue/cell/organ culture. Selection and preparation of explants. Surface sterilization of explants.

4. Types of Plant culture: Callus culture, Suspension cell culture, Meristem culture, Organ culture, Protoplast culture. Subculture techniques. Precautions in Plant Tissue/Cell culture. Applications of plant tissue/cell culture: Micropropagation & Cloning, Genetically modified plants, Medicinal plant improvement, Production of secondary metabolites. Survey of phytochemicals produced through plant cell cultures.

5. Bio-Transformation: Introduction, Types of biotransformation reactions. Design and Methodologies for biotransformation. Cell immobilization, Advantages of cell immobilization. Illustrations of biotransformations with special reference to steroids. Examples of biotransformations using plant cells (Steviol, Codeine, Scopalamine, Hydroxylation of beta methyl digitoxin, Arbutin).

6. Genetic Engineering: Introduction, Properties of DNA. Replication of DNA, and enzymes involved. Steps in engineering the Genes and the enzymes involved. Cloning vectors. Introduction of rDNA into a host cell. Screening and selection of recombinants. Typical examples of Recombinant DNA technology products (human insulin, human growth hormone, Alteplase, Interferons, Vaccines, Coagulation factors etc).


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1. Duby R. C., Textbook of Biotechnology, 2006, S. Chand & Company, New Delhi. 2. Nagori B.P. and Roshan Issarani, Foundations in Pharmaceutical Biotechnology, 2007, Pharma

Book Syndicate, Hyderabad. 3. Sambamurthy K. And Ashutosh Kar, Pharmaceutical Biotechnology, 2006, New Age International

Publishers, New Delhi. 4. Ashutosh Kar, Pharmacognosy and Pharmacobiotechnology, 2nd Ed., 2006, New Age

International Publishers Ltd., New Delhi. 5. NIIR Board of Consultants and Engineers, Enzymes Biotechnology Handbook, 2004, NIIR, New

Delhi. 6. NIIR Board, Plant Biotechnology Handbook, 2004, NIIR, New Delhi. 7. NIIR Board, Biotechnology Handbook, 2003, NIIR, New Delhi.

MPIT 303: Thesis Phase I

Field training for a period of one month in the institute, CRO or R&D of Pharma industries is to be completed at the beginning of Third Semester. The candidate has to prepare an Orientation Report.

FOURTH SEMESTER

MPIT 401: Thesis Phase II

THESIS III and IV SEMESTERS

Phase-I In the third semester, students will be placed to Pharmaceutical Industries / Hospitals / other allied organizations to provide orientation & exposure. Simultaneously the student will carry out a small project leading to a report at the end of that period. The faculty member of the department and an expert from the respective organization jointly evaluate the report for 10 marks. The students are expected to identify a project towards their thesis and start working on it and submit Phase I thesis during this stay. The students will come back to the Department to appear for third semester examination. On completion of third semester examination the students will return back to the industry/ Hospitals / other allied organizations where he was placed and would continue the thesis work under the collective guidance of a faculty member and a guide drawn from the collaborating organization.

Phase-II The students would continue the thesis work in the fourth semester, in collaborating organizations, under the supervision of two guides one from the Department and another from collaborating organization allotted by the Head of the Department of Pharmacy.

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