[Advances in the quantitative analytical methods of drug polymorphism]
Le-Wei Ma1, Wei Du, Chun-Shun Zhao
1Laboratory of Pharmacy and Pharmaceutical Engineering, Sun Yat-sen University, Guangzhou 510006, China.
Yao Xue Xue Bao = Acta Pharmaceutica Sinica
|October 20, 2011
Summary
Drug polymorphism impacts product performance. Quantifying crystal forms ensures consistent drug quality and efficacy, using advanced analytical techniques for pharmaceutical development.
Area of Science:
- Pharmaceutical Sciences
- Solid-State Chemistry
- Analytical Chemistry
Context:
- Drug polymorphism significantly affects pharmaceutical product stability, dissolution, and bioavailability.
- Ensuring consistent product performance necessitates identification and characterization of drug crystal forms.
- Maintaining the integrity of the selected effective crystal form in the final drug product is crucial for quality control.
Purpose:
- To review and highlight quantitative methods for determining drug crystal form content.
- To discuss the principles and recent advancements in various spectroscopic and thermal analysis techniques.
- To explore the application of these quantitative methods in pharmaceutical research and development.
Summary:
- This review focuses on quantitative methods for assessing drug crystal form content, essential for product quality.
- Techniques discussed include X-ray powder diffraction, FT-Raman, IR, terahertz spectroscopy, solid-state NMR, and DSC.
- The progress and application of these methods in pharmaceutical R&D over the past decade are highlighted.
Impact:
- Provides a comprehensive overview of essential analytical techniques for pharmaceutical quality control.
- Facilitates informed selection and implementation of methods for ensuring drug product consistency.
- Supports the development of robust pharmaceutical formulations with predictable performance characteristics.
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