According to a 2019 USP survey and 2020 Pharmaceutical Technology article, the challenges of using novel excipients is a significant barrier to innovation, negatively impacting public health by delaying or preventing drugs from entering the market. USP is collaborating with FDA and industry to develop a systematic approach (quality and safety) to remove the current barriers to using novel excipients in new therapeutics/advanced formulations, including: 1) Launching a Novel Excipients Expert Panel to update < 1074> Excipient Biological Safety Evaluation Guidelines on how to build toxicological studies supporting the safety assessment of novel excipients based on intended use/duration and dose. 2) Developing an Excipients Nomenclature Guideline for naming new excipients in USP–NF, especially complex polymeric excipients for novel applications. 3) Utilizing emerging/iterative approaches to engage stakeholders early in the development of novel excipients including a USP knowledge hub dedicated to furthering dialogue, scientific input, exchange of information, etc.
Learning Objectives:
Understand USP’s convening power to bring together global stakeholders and its unique role and capabilities in developing novel excipients through collaboration with the FDA and industry.
Learn about USP’s tools to support novel excipients development, including the novel excipients information exchange, general chapter update and Excipients Nomenclature Guideline, etc.
Understand the rationale for using USP’s emerging and iterative approaches and possible pathways for novel excipients development.
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