JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD

Course Objectives

Mainly emphasizes on development of process from pilot preparation to bulk

drug synthesis in pharmaceutical industries.

Course Outcome

Students would understand the various aspects regarding process development

and synthesis from pilot preparation to bulk drug.

Basic principles, salient features and applications for the following units:

UNIT - I

Development and scale up techniques for the manufacture of new pharmaceutical active ingredients.

UNIT - II

Process optimisation, maximisation of synthetic route from pilot plant.

UNIT - III

Commercial production of bulk drugs like (i) reaction sequence (ii) process flow and engineering aspects.

UNIT - IV

Process technologies for natural products from plants, animals, marine and microbial sources.

UNIT - V

ICH Q11 for API development.

TEXT BOOKS:

• 1. Pharmaceutical Process Chemistry for Synthesis: Rethinking the Routes to Scale-Up ,
• 2. Peter J. Harrington ,John Wiley and Sons Inc. Publication 2011
• 3. Strategies for Organic Drug Synthesis and Design by Daniel Lednicer, 2nd Edition,John Wiley and Sons Inc. Publication, 2008

REFERENCE:

• 1. Good Pharmaceutical Manufacturing Practice: Rationale and Compliance by Sharp John, CRC st Press; 1 edition Management Information Systems by Laudon Kenneth C. Prentice Hall; 12th edition, 2011.
• 2. ICH Guidelines, www.ich.org