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Phase transformation considerations during process development and manufacture of solid oral dosage forms
Geoff G Z Zhang1, Devalina Law, Eric A Schmitt
1Pharmaceutics and New Technology Center, R4P3/AP9, Global Pharmaceutical R&D, Abbott Laboratories, 100 Abbott Park Road, Abbott Park, IL 60064-6120, USA. Qiu.yihong@abbott.com
Advanced Drug Delivery Reviews
|February 14, 2004
Summary
Understanding solid-state properties is crucial for drug product quality. This review covers polymorphism and process-induced phase transformations in solid oral dosage forms, highlighting their impact on formulation and manufacturing.
Area of Science:
- Pharmaceutical Sciences
- Materials Science
Background:
- Solid oral dosage form quality relies on solid-state properties, formulation, and manufacturing.
- Process-induced solid-state transformations are critical considerations during development.
Purpose of the Study:
- To review polymorphism and phase transformations in solid dosage forms.
- To discuss transformation mechanisms, kinetics, and their impact on manufacturing.
Main Methods:
- Literature review of polymorphism and phase transformation principles.
- Analysis of common unit operations and their potential for inducing phase changes.
Main Results:
- Polymorphism and phase transformations significantly affect drug product performance.
- Unit operations can induce undesirable solid-state changes, impacting stability and bioavailability.
Conclusions:
- Thorough evaluation of solid phases and process-induced transformations is essential for successful formulation and manufacturing.
- Controlling solid-state properties ensures the quality and efficacy of solid oral dosage forms.