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Excipient Taxonomy for the 21st Century
Bruno C Hancock1, David J Goldfarb2
1Pfizer Inc., Groton, CT, USA.
Journal of Pharmaceutical Sciences
|December 16, 2022
Summary
Pharmaceutical excipient characterization is crucial for drug product performance. Current methods are inadequate, necessitating a more systematic approach to defining and controlling excipient properties for improved drug manufacturing.
Area of Science:
- Pharmaceutical Sciences
- Materials Science
- Drug Delivery
Background:
- Excipient properties significantly impact pharmaceutical dosage form performance.
- Accurate specification of excipient chemical and physical characteristics is essential for drug product development and manufacturing.
- Existing methods for describing excipients are insufficient for modern pharmaceutical industry demands.
Purpose of the Study:
- To highlight the limitations of current excipient characterization approaches.
- To advocate for a systematic and comprehensive strategy for specifying and controlling excipient properties.
- To encourage stakeholders to develop improved methods for excipient definition.
Main Methods:
- Review and analysis of current industry practices for excipient specification.
- Identification of key chemical and physical properties critical for excipient performance.
- Discussion of the benefits of a standardized and enhanced approach to excipient characterization.
Main Results:
- Current excipient description methods are outdated and do not meet 21st-century requirements.
- A systematic approach offers significant advantages in controlling and understanding excipient behavior.
- Enhanced characterization leads to more predictable and reliable drug product performance.
Conclusions:
- There is a critical need to update and enhance the way excipient properties are specified and controlled.
- Adoption of a comprehensive strategy will benefit formulators, users, suppliers, and manufacturers.
- Implementing improved excipient characterization is vital for advancing pharmaceutical manufacturing and drug delivery.
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