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Excipients: New opportunities for complex challenges - USP's approaches
Catherine Sheehan1, Jenny Liu1, Peng Zhang1
1Science Division - Excipients, United States Pharmacopeia, Rockville, MD 20852, USA.
Summary
High-quality excipients are crucial for advanced drug delivery systems like nanomedicines. The United States Pharmacopeia (USP) is developing new standards and methods to ensure excipient quality and address variability challenges.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery
- Materials Science
Background:
- Excipients constitute a significant portion of drug products, traditionally specified for intended use rather than composition.
- The rise of nanomedicines and novel delivery systems necessitates higher purity and quality standards for excipients, such as phospholipids used in vaccine delivery.
Purpose of the Study:
- To address the lack of standardized test methods for complex excipients.
- To provide solutions for excipient compositional and variability issues.
- To outline evolving compendial approaches and expanded USP offerings for excipient quality.
Main Methods:
- USP is engaging stakeholders through an "emerging standards" model for flexible and iterative development of quality standards.
- Developing new compendial approaches, including standalone chapters.
- Expanding offerings with analytical reference materials (ARMs), application notes, and technical guides.
Main Results:
- USP is actively collaborating with stakeholders to create standardized test methods for complex/polymeric excipients.
- New solutions are being offered to manage excipient composition and variability.
- An overview of evolving compendial strategies and enhanced support materials is provided.
Conclusions:
- The United States Pharmacopeia (USP) is enhancing its approach to excipient quality standards to meet the demands of advanced drug delivery systems.
- Collaborative efforts and expanded resources aim to improve the reliability and quality of complex excipients.
- These initiatives support the development of innovative medicines by ensuring a robust supply of high-quality excipients.
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