M.Pharm (Quality Assurance)

Subjects:

First Semester MPQC 101 Instrumental methods of Analysis - Theory (Common to all Branches)

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

MPQC 103 Dosage form Design Theory (Common with M.Pharm Industrial Pharmacy)

MPQC 104 Modern Pharmaceutics-Theory (Common with M.Pharm Industrial Pharmacy)

MPQC 105 Quality Assurance Management Theory (Common with M.Pharm Industrial Pharmacy)

MPQP 106 Pharmaceutical Analysis Practical (Common to all Branches)

MPQP 107 Industrial Pharmacy- Practical (Common with M.Pharm Industrial Pharmacy)

Second Semester

MPQC 201. Advanced Pharmaceutical Analysis - Theory

MPQC 202. Quality Assurance of Herbal Drugs Theory (Common with M.Pharm Industrial

Pharmacognosy)

MPQC 203. Pharmaceutical Regulatory affairs

MPQC 204 Quality Assurance Practice Theory

MPQC 205 Biological and Biochemical Analysis Theory (Common with M.Pharm

Pharmacology)

MPQP 206 Advanced Pharmaceutical Analysis Practical

MPQP 207. Quality control and Quality Assurance Practical

Third Semester

MPQC 301 Research methodology and Pharmaceutical statistics - Theory

MPQE 302 Elective

1. MPQE 302(1) Advances in Industrial Pharmacy Theory 2. MPQE 302(2) Pharmaceutical Healthcare theory

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3. MPQE 302(3) Analytical method development Theory 4. MPQE 302(4) Clinical Pharmacology Theory 5. MPQE 302(5) Strategy In Drug Synthesis - Theory 6. MPQE 302(6) Pharmacobiotechnology - Theory

MPQT 303 Thesis Phase I

Fourth Semester

MPQT 401 Thesis Phase II

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Scheme of Examinations M.Pharm.- Quality Assurance

Subject Hrs/Week Credits Evalutation (Marks) L T P Sessional Univ.

exam Total

I.Semester MPQC 101: Instrumental methods of

Analysis - Theory 2 1 -- 3 25 75 100

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

MPQC 103: Dosage form Design Theory 2 1 -- 3 25 75 100

MPQC 104: Modern Pharmaceutics - Theory 2 1 -- 3 25 75 100

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

MPQP 106: Pharmaceutical Analysis Practical -- -- 4 2 40 60 100

MPQP 107: Industrial Pharmacy (Practical) -- -- 6 3 40 60 100

II-Semester MPQC 201: Advanced

Pharmaceutical Analysis Theory 2 1 -- 3 25 75 100

MPQC 202: Quality Assurance of herbal drugs Theory 2 1 -- 3 25 75 100

MPQC 203: Pharmaceutical Regulatory affairs Theory 2 1 -- 3 25 75 100

MPQC 204: Biological and Biochemical Analysis Theory 2 1 -- 3 25 75 100

MPQC 205: Quality Assurance Practice Theory 2 1 -- 3 25 75 100

MPQP 206: Advanced Pharmaceutical Analysis Practical -- -- 6 3 40 60 100

MPQP 207: Quality Control and Quality Assurance Practical -- -- 4 2 40 60 100

III Semester MPQC 301: Research methodology

and Pharmaceutical statistics 2 1 -- 3 25 75 100

MPQC 302: Elective 2 1 -- 3 25 75 100 MPQT 303: Thesis Phase I 15 6 40 60 100

IV Semester MPQT 401 Thesis Phase II 13 40 60 100

Syllabus

FIRST SEMESTER

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

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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.

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

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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.

MPQC 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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MPQC 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.

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.

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. MPQC 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. 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.

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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.

MPQC 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

Books for reference:

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.

MPQP 106: PHARMACEUTLICAL ANALYSIS (Practical) 45 Hrs.

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

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.

MPQP 107: INDUSTRIAL PHARMACY (Practical) 70 Hrs.

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

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Second Semester MPQC 201. Advanced Pharmaceutical Analysis Theory 35 Hrs. 1. Hyphenated techniques: LC-MS: theory ionization techniques (Electrospray, APCI and APPI).

Various modes of recording. Applications in drug development and research. LC-MS/MS: basic principle and applications. GC-MS; interfaces, instrument outline, techniques and applications

2. Capillary electrophoresis: Theory instrumentation. Techniques: capillary zone electrophoresis, capillary gel electrophoresis, capillary isotachophoresis, and capillary isoelectric focusing. Applications. Capillary electrochomatography

3. Chiral HPLC Analysis: Background, Principle of chiral recognition, Direct HPLC analysis, Indirect HPLC analysis, Chiral Stationary phases (CSP): Pirkle CSPs, Polysaccharide CSPs, Cavity CSPs, Protein CSPs. Application in drug development and research.

4. Near Infra red spectrophotometry: Theory, instrumentation and applications. Introduction to Process Analytical Technology (PAT). Particle size measurement by light obscuration

5. Analytical methods based on Functional group analysis: Amino Group: Analytical methods based on addition reaction, electrophilic & nucleophilic aromatic substitution, acyl transfer and complex formation. Hydoxyl group: Analytical methods based on acyl transfer and electrophilic aromatic substitution. Carbonyl group: Analytical methods based on acyl transfer and nucleophilic aliphatic substitution. Carbonyl group: Analytical methods based on addition to carbon oxygen double bond

Books:

1. Pharmaceutical Analysis Modern methods Part B., Ed. James W.Munson, Marcel Dekkar Inc, New York. (Chapter 4 of Indian Reprint 2001).

2. Handbook of Instrumental Techniques for Analytical Chemistry, Frank Settle, Prentice Hall PTR ,Pearson Education (Singapore) Pte.Ltd.(First Indian reprint 2004).

3. Principles of Instrumental Methods of Analysis, 5th edition Skoog, Holler and Nieman, Saunders College Publishing.

MPQC 202 - Quality Assurance of Herbal Drugs 35 Hours

1) The significance of quality for efficacy and safety of herbal medicinal products. Typical problems and challenges in quality control of herbal drugs. Factors affecting Herbal drug quality. Classification of evaluation methods for plant drugs. Macro-morphological, Micro-morphological evaluation of herbal raw materials. WHO guidelines for Sampling of plant drugs.

2) Physicochemical standardization parameters for herbal drugs: Determination of Physical and chemical constants such as extractive values, moisture content, alcohol content, volatile oil content, ash values, bitterness values, foreign matter, and physical constants applicable to the lipid containing drugs, swelling factor, foaming index, filth, insoluble matter etc.

3) Adulteration Introduction, Adulterants, types and methods of adulteration with illustrations and their detection. Contamination of plant drugs, classification of contaminants and Need for their detection. Detection and estimation of Arsenic and Heavy Metals Cadmium and Lead. Determination of Pesticide residues. Microbial contamination, microbial load/counts etc.

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4) Rationale and concepts of metabolite profiling and fingerprinting in assessing the efficacy, quality of phytomedicines and in general to plant drug analysis. Role of Molecular markers in herbal drug quality assurance and associated pitfalls. A brief review of modern extraction methods and sample-preparation techniques for the standardization and analysis of herbal medicinal products.

5) Application of various analytical tools (including Hyphenated analytical technologies [HAT]) in metabolite fingerprinting and profiling of plant drugs and its derivative products in assessing their quality and efficacy. Some typical case studies (at least 3) from scientific publications illustrating the current and modern approaches to plant drug quality assurance.

6) Guidelines proposed by regulatory bodies on quality of herbal medicinal products,

7) Herbal drug preparations and herbal medicinal products. Factors affecting stability of herbal drugs and its formulations, the relevant ICH guidelines and methods of stability testing. WHO guidelines on GMP for herbal medicines.

Books for Reference:

1. Quality Control Methods for Medicinal Plant Materials- WHO, Geneva.

2. Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines, 1993, WHO, Regional Office for the Western Pacific, Manila.

3. Guidelines for the Assessment of Herbal Medicines, 1991, WHO, Geneva.

4. Good Manufacturing Practices: updated supplementary guidelines for the manufacture of herbal medicines, WHO, July 2005.

5. Pharmacopoeia of India, Govt. of India, Ministry of Health,4th Edition,1996.

6. United States Pharmacopoeia, US pharmacopoeial Convention Inc. Rocville, USA,2000.

7. Evans, W.C., Trease and Evans Pharmacognosy, ELBS / Bailliere Tindall, London,15th edition (Reprint 2006).

8. World Health Organization. Regulatory Situation of Herbal Medicine. World Wide Review. Geneva, Switzerland: World Health Organization; 1998:1-5.

9. GMP for Botanicals : Regulatory and Quality Issues on Phytomedicines, edited by Pulok K. Mukherjee and Robert Verpoorte. New Delhi, Business Horizons, 2003

10. Liang, Y.Z., Xie, P., and Chan, K., Quality control of herbal medicines, J Chromatogr B Analyt Technol Biomed Life Sci. 2004, 812: 53-70. Review.

11. Quality Control on Herbal Drugs - Pulok K. Mukherjee, Eastern Publishers (Business Horizons Ltd.) New Delhi 2002.

12. Pharmacognosy, Phytochemistry, Medicinal Plants by Jean Bruneton (1999)

MPQC 203 Pharmaceutical Regulatory affairs 35 Hours

1. 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

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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

2. European Commission regulatory affairs: Procedure for marketing authorization in European Commission Countries mutual recognition process centralized procedure decision making procedure

3. Organisation and functioning of ICH overview of various ICH guidelines. ICH quality guidelines: Stability Testing of New Drug Substances and Products Stability Testing : Photostability Testing of New Drug Substances and Products, Stability Testing for New Dosage Forms, Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products, Evaluation of Stability Data, Impurities in New Drug Substances, Impurities in New Drug Products, Impurities: Guideline for Residual Solvents,

4. GMP certification as per WHO: need and procedure for certification. ISO 9000 Salient features

5. Good Clinical Practice : Basic rules to carry out clinical investigation of drugs in Phase I, II, III, IV clinical trials - the subjects of clinical investigation - the documentation of studies - ethical aspects of clinical investigations of drugs.

Reference: 1. US FDA CDER hand book, Department of Health and Human Services, Food and Drug

Administration, Center for Drug Evaluation and Research 2. ICH quality guidelines www.ich.org3. "Good Manufacturing Practices for Pharmaceuticals", H. Willig, M.M.Tuckeman and

W.S.Hitchings, Drugs and Pharm. Sci. Series, Vol. 16, Marcel Dekker Inc., N.Y. 4. Quality Assurance of Pharmaceuticals: A compendium of guidelines and related materials, Volume I

& II, World Health Organisation, Pharma Book Syndicate, Hyderabad. 5. Notice to applicants volume 2a,, Procedure for Marketing Authorisation, European commission

Enterprise directorate-general single market : management & legislation for consumer goods, Pharmaceuticals : regulatory framework.

MPQC 204 Biological and Biochemical Analysis Theory 35 Hrs.

1. Design and analysis of biological assay-precision, estimation of error, assay depending on individual effective dose and measured effect on individual biological system. Assay depending on quantal responses and combination of potency estimates. Bioassay of heparin, oxytocin, vaopressin, insulin, digoxin and amylase.

2. Bio assay of the following products: Vaccines : Diphtheria, Tetanus, Pertusis, Plague, Rabies, Smallpox and Typhoid - Antitoxins : Diphtheria, Rabies anti serum and Tetanus antitoxin

3. Pyrogen test including Lal test Test for Histamine like substance, Freedom from undue toxicity and living contaminants in vaccines.

4. Microbiological Assays of Vitamins and Antibiotics.

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5. Immuno Assays including Radio Immuno Assays. 6. Affinity Chromatography 7. Sterility tests

Reference:

1. Pharmacopoeia of India, 4th Edition 1996. 2. British Pharmacopeia, 1993 3. Biological standardization Burn, Fininey and Godwin 4. Microbial Assays Barton J.Wright 5. Gennaro A R, Remington: The Science and Practice of Pharmacy, 20th Edn.,Vol I & II, Lippincott

Williams & Willkins, Philadelphia, PA, 2000.

MPQC 205: Quality Assurance Practice (Theory) 35 Hrs.

1. Validation: Process validation: Design, development and process validation methods- protocols- methodology and interpretation of data for pharmaceutical operations involved in the production of pharmaceutical products with special reference to tablets, suspensions. Validation of process like mixing, granulation, drying, compression filling and water process system.

2. Cleaning validation, Vendor validation, Vendor audit, Validation of service: Training, maintenance and packing.

3. Equipment qualification: Installation qualification and operational qualification for sterilization equipments like autoclave, oven and membrane filter.

4. US FDA guidelines for GLP for laboratories conducting non clinical animal testing. NABL Accreditation. organisation and functioning of National Accreditation Board for Testing & Calibration laboratories. Accreditation process, criteria for accreditation

5. In process Quality control: In process control during component manufacture- solid dosage forms-Liquid Dosage forms-semi solid dosage forms-inhalations-sterile solutions-novel drug delivery systems. Line clearance Change control

6. Quality control of primary packing materials: IP, BP & USP specifications for plastic containers, glass containers, rubber closures

Books:

1. NABL 100 (Issue 1, 1996), National Accreditation Board for Testing & Calibration laboratories., Department of Science & Technology, Ministry of Science & Technology, Government of India.

2. "Pharmaceutical Process Validation", B.T.Loftus & R.A.Nash, Drugs and Pharm Sci. Series, Vol. 23, Maarcel Dekker Inc., N.Y.

3. Pharmacopoeia of India,4th Edition(1996)Govt.of India,Ministry of Health.

4.

5. United State Pharmacopeia(2000)US pharmacopeial convention Inc.Rocville,USA.

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MPQP 206. Advanced Pharmaceutical Analysis Practical 70 Hrs.

a. Assay of multi drug formulations covering different techniques like UV, HPLC and Spectrofluorimetry.

b. Quality Control test for cosmetics as per BIS Specifications.

c. Any other experiments to substantiate theory (2.1. Advanced Pharmaceutical Analysis Theory and 2.3. Quality control of cosmetics theory)

MPQP 207Quality control and Quality Assurance Practical 70 Hrs.

1. Stability studies of marketed formulations as per ICH guidelines (The Experiment shall be started at the beginning of the semester)

2. Experiments on process validation.

3. Calibration of spectrophotometer

4. Calibration of volumetric apparatus.

5. Chromatographic analysis of plant drugs for some phytoconstiuents such as alkaloids, Anthracene glycosides, volatile oils.

6. Proximate analysis of plant-drugs to determine extractive values, ash values, insoluble matter foreign matter, welling factor etc.

7. Determination of volatile oil content of plant drug.

8. Estimation of some phytoconstiuents.

9. Pharmacopoeial monograph of selected herbal drugs.

10. Any other experiments to substantiate theory

THIRD SEMESTER MPQC 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

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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.

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.

MPQE 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.

Books for Reference:

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.

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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.

MPQE 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. 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

g) by WHO h) by Government of India i) by Various state governments

MPQE 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.

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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 methodcollaborative test two sample collaborative testing, control charts.

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. ative inorganic analysis 5th 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.

MPQE 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.

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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.

Books for reference:

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

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

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.

MPQE 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.

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

h. Antihistaminic agents: Promethazine, Cyclizine, Diphenhydramine. i. Adrenergic agents: Stimulants, Epinephrine, Ephedrine. j. Adrenergic blocking agents: Propranolol, Guanethidine. k. Psychotropic agents: Chlorpromazine, Chloprothixene. l. Antidepresants: Imipiramine. m. CNS Stimulants: Amphetamine. n. Narcotic analgesics: Meperidine, Methadone, Propoxyphene.

Books for Reference:

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

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.

MPQE-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

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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).

Books for Reference:

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.

MPQT 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

MPQT 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

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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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