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PHARMACEUTICAL PRODUCT DEVELOPMENT BP813ET
UNIT -01
- 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 -02
- 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 -03
- 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 -04
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 -05
- Selection and quality control testing of packaging materials for pharmaceutical product development- regulatory considerations.