JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD

Course Objective

This topic will impart the knowledge about principles of drug discovery development

of INS, NDA and ANDA. This also gives the information about pre-formulation studies, protocols of stability studies, pilot plant scale up and packaging of pharmaceuticals.

Course Outcomes

Upon completion of this course the student should be able to

• To understand the new product development process
• To understand the necessary information to transfer technology from R&D to actual manufacturing by sorting out various information obtained during R&D
• To elucidate necessary information to transfer technology of existing products between various manufacturing places

UNIT - I

Principles of Drug discovery and development: Introduction, Clinical research process. Development and informational content for Investigational New Drugs Application (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Supplemental New Drug Application (SNDA), Scale Up Post Approval Changes (SUPAC) and Bulk active chemical Post approval changes (BACPAC), Post marketing surveillance, Product registration guidelines – CDSCO, USFDA

UNIT - II

Pre-formulation studies: Introduction/concept, organolepti properties, purity, impurity profiles, particle size, shape and surface area. Solubility, Methods to improve solubility of Drugs: Surfactants & its importance, co-solvency. Techniques for the study of Crystal properties and polymorphism. Pre- formulation protocol, Stability testing during product development.

UNIT - III

Pilot plant scale up: Concept, Significance, design, layout of pilot plant scale up study, operations, large scale manufacturing techniques (formula, equipment, process, stability and quality control) of solids, liquids, semisolid and parenteral dosage forms. New era of drug products: opportunities and challenges.

UNIT - IV

Pharmaceutical packaging: Pharmaceutical dosage form and their packaging requirements, Pharmaceutical packaging materials, Medical device packaging, Enteral Packaging, Aseptic packaging systems, Container closure systems, Issues facing modern drug packaging, Selection and evaluation of Pharmaceutical packaging materials. Quality control test: Containers, closures and secondary packing materials.

UNIT - V

Technology transfer: Development of technology by R & D, Technology transfer from R & D to production, Optimization and Production, Qualitative and quantitative technology models. Documentation in technology transfer: Development report, technology transfer plan and Exhibit.

REFERENCE BOOKS:

• 1. The process of new drug discovery and development. I and II Edition (2006) by Charles G. Smith, James T and O. Donnell. CRC Press, Group of Taylor and Francis.
• 2. Leon Lac Lachman, Herbert A. Liberman, Theory and Practice of Industrial Pharmacy. Marcel Dekker Inc. New York.
• 3. Sidney H Willing, Murray M, Tuckerman. Williams Hitchings IV, Good manufacturing of pharmaceuticals (A Plan for total quality control) 3rdEdition. Bhalani publishing house Mumbai.
• 4. Tablets Vol. I, II, III by Leon Lachman, Herbert A. Liberman, Joseph B. Schwartz, 2nd Edn.
• (1989) Marcel Dekker Inc. New York.
• 5. Text book of Bio- Pharmaceutics and clinical Pharmacokinetics by Milo Gibaldi, 3rd Edn, Lea & Febriger, Philadelphia.
• 6. Pharmaceutical product development. Vandana V. Patrevale. John I. Disouza. Maharukh T. Rustomji. CRC Press, Group of Taylor and Francis.
• 7. Dissolution, Bioavailability and Bio-Equivalence by Abdou H.M, Mack Publishing company, Eastern Pennsylvania.
• 8. Remingtons Pharmaceutical Sciences, by Alfonso & Gennaro, 19th Edn (1995) OO2C Lippincott; Williams and Wilkins A Wolters Kluwer Company, Philadelphia.
• 9. The Pharmaceutical Sciences; the Pharma Path way ‘Pure and applied Pharmacy’ by D. A Sawant, Pragathi Books Pvt. Ltd.
• 10. Pharmaceutical Packaging technology by D.A. Dean. E.R. Evans, I.H. Hall. 1st Edition (Reprint 2006). Taylor and Francis. London and New York. M.Pharm I Year I Sem (Pharmaceutical Quality Assurance)