Product Development and Technology Transfer detailed syllabus for Pharmacy (Pharma) for 2021 regulation curriculum has been taken from the Anna Universities official website and presented for the Pharma students. For course code, course name, number of credits for a course and other scheme related information, do visit full semester subjects post given below.
For Pharmacy 5th Sem scheme and its subjects, do visit Pharma 5th Sem 2021 regulation scheme. For Professional Elective-III scheme and its subjects refer to Pharma Professional Elective-III syllabus scheme. The detailed syllabus of product development and technology transfer is as follows.
Course Objectives:
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Unit I
PRINCIPLES OF DRUG DISCOVERY AND DEVELOPMENT 9 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), Post marketing surveillance, Product registration.
Unit II
PRE-FORMULATION STUDIES 9
Introduction/concept, organoleptic properties, purity, impurity profiles, particle size, shape and surface area. Solubility, Methods to improve solubility of Drugs: Surfactants & its importance, cosolvency. Techniques for the study of Crystal properties and polymorphism.
Unit III
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Unit IV
PILOT PLANT SCALE TECHNIQUES 9
Concept, significance, pilot plant scale up activities – general consideration for solids, semisolids, liquid, its relevant documentation and contract manufacturing.
Unit V
TECHNOLOGY TRANSFER 9
Scope, organization and management, production, quality control, premises and equipment, documentation, qualification and validation.
Course Outcomes:
- Understand the process in developing new drug substances.
- Perform an experiment using modern equipment to investigate the physicochemical properties of the drug substances.
- Design, develop and perform an experiment using modern equipment to evaluate the packing materials.
- Demonstrate the different process and activities involved in the pilot plant scale up of the products.
- Design and develop the process for successful transfer of the developed product.
- Understand the systems and process for the development and transfer of the product into the pharmaceutical industries.
Text Books:
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Reference Books:
- Remingtons Pharmaceutical Sciences, by Alfonso & Gennaro, 19th Edn.(1995)OO2C Lippincott; Williams and Wilkins A Wolters Kluwer Company, Philadelphia.
- The Pharmaceutical Sciences; the Pharma Path way ‘Pure and applied Pharmacy’ by D. A Sawant, Pragathi Books Pvt.Juran’s Quality Handbook, Sixth Edition, Joseph M. Juran and Joseph A. De Feo, ASQ Publications.
- Pharmaceutical Packaging technology by D.A. Dean. E.R. Evans, I.H. Hall. 1 st Edition (Reprint 2006). Taylor and Francis. London and New York.
For detailed syllabus of all the other subjects of Pharmacy 5th Sem, visit Pharma 5th Sem subject syllabuses for 2021 regulation.
For all Pharmacy results, visit Anna University Pharma all semester results direct link.