PRODUCT DEVELOPMENT AND FORMULATION (MPY- 104) SYLLABUS

PRODUCT DEVELOPMENT AND FORMULATION (MPY-

104) SYLLABUS

Theory

1. Preformulation studies: Study of physical, chemical and

pharmaceutical factors influencing formulation of drugs.

2. Formulation additives: Study of formulation additives, Drug – Excipient, Excipient - Excipient interactions and Incompatibilities.

3. Solubilization: Theory of solubilization, methods of solubility enhancement and factor influencing solubility. Solids dispersion.

4. Dissolution Technology: Design of dissolution apparatus, dissolution media, dissolution testing of different types of dosage formulations, data interpretation, in-vitro and in-vivo correlation.

5. Tablets: Recent advances in tablet technology and automation in manufacturing process, formulation and evaluation of dispersible, effervescent, floating and multilayers tablets.

6. Formulation consideration and evaluation: Parenterals and Ophthalmics.

7. Polymers: Classification, General method of synthesis, Properties, Characterization, Evaluation and Application in pharmacy. A detail account of biodegradable polymers.

8. Nutraceuticals: Introduction, formulations, uses, recent developments and law governing nutraceuticals.

9. Pharmaceutical packaging: Packaging materials, type and tests of containers and closures, Pilot plant scale up technique.

10. Drug stability: Stability study programmes for formulations. Determination of Expiry date (shelf life) and Overage calculations. Stability indicating assays and ICH guidelines for stability.

11. OptimizationTechniques: Computers in pharmacy, Optimization techniques, Computer aided drug formulations.

Books and References Recommended:

1. Swarbrick, J. and Boyran, J. C., Encyclopedia of Pharmaceutical Technology” Vol.1-3, Marcel Dekkar, Inc., New York.

2. Gennaro, A.R., Remington’s “The Science and practice of

Pharmacy”, Lippincot, Wiliams & Wilkins, Philadelphia.

3. Aulton, M.E., “Pharmaceutics- The science of doses form design”, Churchill Livingstone, London.

4. Carstersen, J.T., “Drug stability: Principal & practice”, Marcel Dekker, Inc., NY

5. Banker and Rhodes, Modern Pharmaceutics. Marcel Dekker Inc. NY.

6. Liium, L. and Davis, S.S., “Polymers in controlled drug delivery”, Wright Bristol.

7. Kibbe, “ Hand book of Pharmaceutical Excipients., Pharmaceutical Press, London.

8. Lachmen, L. & Lieberman, H.A., “ Theory and Practice of Industrial Pharmacy”, Verghese publishing house, Bombay.

9. Martin, Physical Pharmacy.

10. Lieberman, H.A. & Lachmen, L., “ Pharmaceutical Dosage forms – Dispersed Systems’’ Vol.1-3 ,Marcel Dekker, Inc., NY.

11. Avise, K. E. & Lachmen, L., “ Pharmaceutical Dosage forms – “Parenteral Medications’’ Vol.1-3 ,Marcel Dekker, Inc., NY.

12. Lieberman, H.A. & Lachmen, L., “ Pharmaceutical Dosage forms – Tablets’’ Vol.1-3 ,Marcel Dekker, Inc., NY.

13. Yalkowsky,S.H.” Techniques of Solubilization of drugs”, Marcel Dekker, Inc., NY.

DRA, INTELLECTUAL PROPERTY RIGHTS AND QUALITY ASSURANCE (MPY -103) SYLLABUS

DRA, INTELLECTUAL PROPERTY RIGHTS AND QUALITY ASSURANCE (MPY -103) SYLLABUS

Theory

1. Requirements of GMP, CGMP, GLP, USFDA, WHO guidelines and ISO 9000 Series.

2. Drugs and Cosmetics Acts and Rules, Drug Regulatory Affairs.

3. Documentation – Protocols, Forms and Maintenance of records in Pharmaceutical industry.

4. Clinical Trials and toxicological evaluation of drugs. Preparation of documents for New Drug Approval and Export Registration.

5. Processing and its application, Intellectual Property Rights (Patent, Copy right and Trade marks).

6. Sewage disposal and Pollution control.

7. Concepts in Validation, Validation of manufacturing, Analytical and Process validation and its Application.

8. Basic concept of Quality Control and Quality Assurance systems, Source and Control of Quality variation of Raw materials, Containers, Closures, Personnel, Environmental, etc.

9. In process quality control tests, IPQC problems in Pharmaceutical industries. ICH Guidelines

10. Sampling plans, Sampling and Characteristic curves.

11. Master formula generation and Maintenance, Standard Operating Procedure (SOP) for different dosage forms.

Books and References Recommended:

1. Willing, Tuckerman and Hitching, Good Manufacturing Practices for Pharmaceuticals.

2. Drugs and Cosmetic Acts and Rules.

3. Bharathi, Drugs and Pharmacy Laws in India.

4. Patel, Industrial Microbiology.

5. Loftus, B.T. and Nash,R.A., Pharmaceutical Process Validation.

6. Bolton, S., Pharmaceutical Statistics.

7. Banker, G.S. and Rhodes, C.T., Modern Pharmaceutics.

8. OPPI, Quality Assurance.

9. Carletiori, Validation of Aseptic Pharmaceutical Process.

10. Garfield, Quality Assurance Principles for Analytical Laboratories.

11. Indian Pharmacopoeia.

12. British Pharmacopoeia.

13. United State Pharmacopoeia.

BIOTECHNOLOGY & BIOINFORMATICS (MPY 102) SYLLABUS

BIOTECHNOLOGY & BIOINFORMATICS (MPY 102) SYLLABUS

1. Genetics: Structure & Function of DNA, DNA Replication & Repair, Expression of Genetic Information: Structure & Function of RNA, Transcription, Genetic code, Translation, Post translational modification.

2. Recombinant DNA Technology: Constructing Recombinant DNA molecules Restriction enzymes, Vectors, Gene Cloning, Genomic libraries, Polymerase Chain reaction – based DNA cloning, Restriction mapping, Blotting techniques, DNA sequencing, Pharmaceutical applications of recombinant DNA.

3. Gene Therapy: General Introduction, Potential target diseases for Gene therapy, Gene transfer methods, Clinical studies, Pharmaceutical production & Regulation.

4. Basics of Immunology, Monoclonal antibodies & Hybridoma technology & its Applications. Vaccines – Conventional vaccines, Modern Vaccine technologies, Genetically improved live vaccines, Genetically improved subunit vaccines, Pharmaceutical considerations.

5. Fundamentals of Cell biology: Cell organization and plasma membrane: Transport of

substances across the membrane. Cellular reproduction: The Cell cycle, Mitosis & Meiosis,

Apoptosis. Cell Signaling: Communication between cells and their environment

6. Molecular biology of cancer: Causes of Cancer & Genetics of Cancer, New strategies for combating cancer.

7. Molecular, Structural and Chemical Biology in pharmaceutical research: Molecular biology of disease and invivo transgenic models, Genomic protein targets and recombinant therapeutics, Structural biology and rational drug design, Chemical biology and Molecular diversity, Gene therapy & DNA/ RNA targeted therapeutics. Future of pharmaceutical

research.

8. Introduction to Bioinformatics: Biological databases, Sequence analysis, Protein structure, Genetic and physical mapping, Application of bioinformatics in pharmaceutical industries.

9. Biostatistics – Graphical representation of Data, Descriptive statistics, Normal distribution, Probability distribution, Sampling & Sampling plans.

Recommended Readings

1. Lehninger ., Principles of Biochemistry

2. Karp, G.,Cell & Molecular Biology.

3. Crommelin, D.J., A., and Sindelar R.D., Pharmaceutical

Biotechnology.

4. Templeton N.S., and Lasic. D.D., Gene Therapy.

5. Benjamin Lewin, Genes.

6. Watson and Trooze, Recombinant DNA Techniques

7. Lesk., Introduction to Bioinformatiics.

8. Watson, Molecular Biology of cell.

9. Old and Primrose, Principles of Gene Manipulations.

10. Watson, J.D., Gilman, M., Recombinant DNA Technology

11. Baxevanis, A.D., Frana, Duelette, B.F.,Bioinformatics

12. Alberts, B., Johnson, A., Lewin, J., Raff, M., Roberts, K., Walter, P.,

molecular biology of the cell

13. Paul, W.E, Fundamentals of Immunology

14. Klug, W.S., Cummings, M.R., Essentials of Genetics

15. Glick, B.R., Pasternak, J.J., Molecular Biotechnology

16. Walker, J.M., Ripley, R., Molecular biology and Biotechnology

17. Bolton, S., Pharmaceutical Statistics.

MODERN ANALYTICAL TECHNIQUES (MPY 101) SYLLABUS

MODERN ANALYTICAL TECHNIQUES (MPY 101) SYLLABUS

Theory

1. Theory, Instrumentation, Methods and Applications of VU Spectrophotometer.

2. Theory and Instrumentation of IR and FT-IR, its advantage and applications in Structural elucidation.

3. NMR, C13 NMR, Origin of spectra, Chemical shifts, Spin-spin coupling,
Coupling constant, Instrumentation and application for Structural elucidation.

4. Mass spectra, Instrumentation, Fragmentation pattern and applications
for Structural elucidation. Application of GC-Mass, HPLC-Mass for complex mixtures.

5. Theory, Instrumentation and application for the following:
i) Fluorescence
ii) X – Ray crystallography
iii) Atomic spectroscopy
iv) Ultra centrifugation
v) ESR
vi) Liquid Scintillation spectrometry
vii) Auto radio grapy

6. Separation Techniques; Fundamental principles, Basic instrumentation, Qualitative and Quantitative Pharmaceutical applications of Gas-liquid Chromatography, HPLC, HPTLC, 
Gel Chromatography, Electrophoresis and Ion-pair Chromatography.

7. General Principle, instrumentation and application of optical 
rotatory dispersion (ORD) and Circular dichroism (CD).

8. Immunoassay Techniques: Enzyme and Radioimmunoassay
techniques. Theory, Methods and applications.

9. Thermal methods: Thermo Gravimetry (TG), Differential Scanning 
Calorimetry (DSC), Differential Thermal Analysis (DTA).

10. Principles and application of light, Phase contrast, Scanning and
Transmission electron microscopy, Cytometry and Flow cytometry.

Books and References Recommended:

1. Florey, Analytical Profiles of Drugs, Vol.1-16.
2. Sinder, Text Book of HPLC.
3. McLafferty, Mass Spectrometry.
4. Rao,C.N., Ultraviolet Visible Spectroscopy for Chemical Application.
5. Silverstein, Basseler, Morril, Spectophotometrc Identification of Organic
Compounds.
6. Rao,C.N., Chemical Application of Infrared Spectroscopy.
7. Weissberger, Physical Methods in Organic Chemistry.
8. Kiencz, B. and Dierasi, C., Interpretation of Mass Spectra of Organic
Compounds.
9. Jackmann, Application of NMR Spectra to Organic Compounds.
10.Willard, Merrit and Dean, Instrumental Methods of Analysis.
11. Elliel, E.L., Stereochemistry of Carbon Compounds.
12. Naahod, P., Physical Methods of Structure Determination.
13. Stahl, Thin Layer Chromatography.
14. Ewing, Instrumental Methods of Chemical Analysis.
15. Block and Durrum, Paper Chromatography and Electrophoresis.
16. Remington’s Pharmaceutical Sciences.
17. Sirmer, Spectroscopic Analysis.

M. PHARMA. 1st SEMESTER SYLLABUS (common for all branches)

MODERN ANALYTICAL TECHNIQUES (MPY 101) SYLLABUS

BIOTECHNOLOGY & BIOINFORMATICS (MPY 102) SYLLABUS

DRA, INTELLECTUAL PROPERTY RIGHTS AND QUALITY ASSURANCE (MPY -103) SYLLABUS

PRODUCT DEVELOPMENT AND FORMULATION (MPY-104) SYLLABUS