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FORMULATION AND DEVELOPMENT


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Challenges and Opportunities in Developing Up-to-Date USP–NF Excipient Monographs


Tong (Jenny) Liu, PhD1 , Catherine Sheehan, MS., MS.2


and Steven Wolfgang, PhD3 1


,


Scientific Liaison for Excipients and Harmonization, United States Pharmacopeial Convention, Rockville, MD 2Senior Director, Science –Excipients, United States Pharmacopeial Convention, Rockville, MD 3Lead Consumer Safety Officer, United States Food and Drug Administration, Silver Spring, MD


Abstract


As the third part and final part of this series, this article focuses on future directions and challenges faced by the USP excipient Up- to-Date initiative with regard to excipients. The article will provide the key findings of the USP Excipients Workshop held in November 2015 that focused on several topics, including challenges involved with introducing new or missing NF excipient monographs and opportunities to update USP excipient standards used in injectable and biologic dosage forms. Excipients are often complex substances that, within their definition and specification in a USP monograph, can exhibit relatively wide variation in composition. This article also explores the challenges involved in updating current monographs to improve characterization of excipient composition and thereby assure that impurities, concomitant


32 | | May/June 2016


components, and certain allowed additives are properly accounted for and controlled. Additionally, excipient physical/chemical properties not identified in an excipient monograph might be considered critical material attributes (CMA) to assure consistent and reliable excipient performance within the context of use in a drug product.1


Proper


control of CMA may improve selection of the right excipient for the intended use and reduce the risk to drug product quality caused by excipient variability. This article also discusses excipient nomenclature inconsistencies between USP and the United States (U.S.) Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) Inactive Ingredients Database (IID), USP excipient standards for coprocessed excipients, and excipients used as atypical actives. This article also provides an overview of official USP General Notices and standards that support current


excipient monograph standards and possible opportunities for developing chapters that could help drug makers gain a better understanding of excipient composition, impurities, and physical/chemical properties that may impact variability to help in selection of the right excipient. The article concludes with information on how to submit a Request for Revision to USP.


Introduction


The United States Pharmacopoeia – National Formulary (USP–NF) currently provides tests, procedures, and acceptance criteria that help to ensure the quality and safety of excipients used in drug products and dietary supplements marketed in the U.S. The standards in USP–NF are also recognized globally, as they are used worldwide. The USP–NF defines pharmaceutical excipients


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