Active Pharmaceutical Ingredient Process Development Detailed Syllabus for B.Tech third year first sem is covered here. This gives the details about credits, number of hours and other details along with reference books for the course.
The detailed syllabus for Active Pharmaceutical Ingredient Process Development B.Tech 2016-2017 (R16) third year first sem is as follows.
B.Tech. III Year I Sem. L/T/P/C
Course Code:PS506 3/0/0/3
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.
TEXT BOOKS:
- Pharmaceutical Process Chemistry for Synthesis: Rethinking the Routes to Scale-Up ,
- Peter J. Harrington ,John Wiley and Sons Inc. Publication 2011
- Strategies for Organic Drug Synthesis and Design by Daniel Lednicer, 2nd Edition,John Wiley and Sons Inc. Publication, 2008
REFERENCE:
- Good Pharmaceutical Manufacturing Practice: Rationale and Compliance by Sharp John, CRC Press; 1st edition Management Information Systems by Laudon Kenneth C. Prentice Hall; 12th edition, 2011.
- ICH Guidelines, www.ich.org
For all other B.Tech 3rd Year 1st Sem syllabus go to JNTUH B.Tech B. Pharm 3rd Year 1st Sem Course Structure for (R16) Batch.
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