BP813ET. PHARMACEUTICAL PRODUCT DEVELOPMENT Books
All books are given below after syllabus
Unit-I
Introduction to pharmaceutical product development, objectives, and regulations related to
preformulation, formulation development, stability assessment, manufacturing and quality
control testing of different types of dosage forms.
Unit-II
An advanced study of Pharmaceutical Excipients in pharmaceutical product development with a
special reference to the following categories:
Solvents and solubilizers. Cyclodextrins and their applications.
Non - ionic surfactants and their applications. Polyethylene glycols and sorbitols.
Suspending and emulsifying agents. Semi solid excipients.
Unit-III
An advanced study of Pharmaceutical Excipients in pharmaceutical product development with a
special reference to the following categories:
Tablet and capsule excipients. Directly compressible vehicles. Coat materials.
Excipients in parenteral and aerosols products. Excipients for formulation of NDDS.
Selection and application of excipients for pharmaceutical formulations, with specific industrial
applications.
Unit-IV
Optimization techniques in pharmaceutical product development. A study of various
optimization techniques for pharmaceutical product development with specific examples.
Optimization by factorial designs and their applications. A study of QbD and its application in
pharmaceutical product development.
Unit-V
Selection and quality control testing of packaging materials for pharmaceutical product
development- regulatory considerations.
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