Dear all,

    The AAPS Excipient Community just had our last monthly Scientific Discussion on Complex Excipient.  @Allison Radwick @Hong Wang @Panos Constantinides @Ketaki Patwardhan @Chris Moreton and many other experts exchanged perspectives on how excipients are complex material, current progress on providing guidance to categorizing/characterizing complex excipients in USP, and manufacturing failure/patient safety impact caused by choosing the wrong type/grade of excipients. The exchange definitely stimulated more attention and more interest in the investigation/discussion on how to choose the right type/grade of excipients. Here we'd like to share some references provided by the participants. Many thanks to the leading speakers: @Allison Radwick and @Hong Wang!

    Happy Holidays and Happy New Year! 

    Reference:

Excipient Composition and Impurity Joint Subcommittee (EXC Comp and Impurity JS) has proposed definitions of excipient components including complex excipients in a recently developed Stimuli article, Proposed Definitions of Excipient Components – Revisions to 2018 Definitions, please refer to attached file.

In USP Excipient Nomenclature Guidelines, https://www.usp.org/health-quality-safety/compendial-nomenclature, USP guides stakeholders on how to name single- versus multi-component Excipients in Section 3.

https://www.complexgenerics.org/resource/characterization-of-complex-excipients-and-formulations/" title="https://www.complexgenerics.org/resource/characterization-of-complex-excipients-and-formulations/" href="https://www.complexgenerics.org/resource/characterization-of-complex-excipients-and-formulations/" rel="noreferrer noopener" target="_blank" class="fui-Link ___10kug0w f3rmtva f1ewtqcl fyind8e f1k6fduh f1w7gpdv fk6fouc fjoy568 figsok6 f1hu3pq6 f11qmguv f19f4twv f1tyq0we f1g0x7ka fhxju0i f1qch9an f1cnd47f fqv5qza f1vmzxwi f1o700av f13mvf36 f1cmlufx f9n3di6 f1ids18y f1tx3yz7 f1deo86v f1eh06m1 f1iescvh fhgqx19 f1olyrje f1p93eir f1nev41a f1h8hb77 f1lqvz6u f10aw75t fsle3fq f17ae5zn">More USP perspectives: Browse Outcomes - The Center for Research on Complex Generics (CRCG)

Real-life example: Effect of Material Properties and Variability of Mannitol on Tablet Formulation Development | Pharmaceutical Research (springer.com)

Please feel free to add more reference or participate in the discussion offline with the community by responding to the thread.

Best regards,

Jiaying (Ingrid) Liu, Secretary of AAPS Excipient Community

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Jiaying Liu
Senior Scientist
Merck & Co, Inc - Rahway, NJ
Kenilworth NJ
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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