Bpharm 8th-semester notes

Pharmaceutical Product Development Notes – Bpharm 8th Sem Free

Pharmaceutical Product Development Notes Unit 1 – 5


UNIT – 1

Introduction to pharmaceutical product development, objectives, regulations related to preformulation, formulation development, stability assessment, manufacturing and quality control testing of different types of dosage forms.

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UNIT – 2

An advanced study of Pharmaceutical Excipients in pharmaceutical product development with a special reference to the following categories
i. Solvents and solubilizers
ii. Cyclodextrins and their applications
iii. Non – ionic surfactants and their applications
iv. Polyethylene glycols and sorbitols
v. Suspending and emulsifying agents
vi. Semi solid excipients

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UNIT – 3

An advanced study of Pharmaceutical Excipients in pharmaceutical product development with a special reference to the following categories
i. Tablet and capsule excipients
ii. Directly compressible vehicles
iii. Coat materials
iv. Excipients in parenteral and aerosols products
v. Excipients for formulation of NDDS
Selection and application of excipients in pharmaceutical formulations with specific industrial applications

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UNIT – 4

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.

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UNIT – 5

Selection and quality control testing of packaging materials for pharmaceutical product development- regulatory considerations.

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