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Executive Summary

EXCIPIENT SAFETY GUIDELINES DEVELOPED BY INTERNATIONAL INDUSTRY GROUP are being prepared for journal publication later this year. The International Pharmaceutical Excipients Council, a group composed of 100 companies worldwide which manufacture or use excipients, has composed guidelines for testing new drug excipients which may be published in Regulatory Pharmacology and Toxicology this summer. IPEC developed these guidelines as part of a strategy to expedite the review of new pharmaceutical excipients, council member Marshall Steinberg, PhD, Hercules VP-Health & Environment, explained at a seminar with FDA headquarters staff in mid-January. There are no regulatory guidelines available which specifically address the requirements for testing a material intended for use as a new excipient in pharmaceuticals, Steinberg pointed out. That situation has created a de facto limitation on the use of new excipients. Only materials which have been previously approved for use in a pharmaceutical product or which have been used in foods can safely be considered in the absence of testing procedures for new ingredients. The IPEC recommendations consist of "Universal Guidelines," which identify a series of tests to be performed to give a baseline set of data for all candidate compounds, and additional test requirements for specific routes of administration. The data requirements of the universal guidelines include a number of interim checkpoints which correlate with use of a proposed excipient in a particular type of drug product, i.e, a product with a short half-life, a product for limited repeated intake or a product to be taken chronically or chronically intermittently. Transdermal, topical, parenteral, inhaled or intranasal, and ophthalmic dosage forms all require additional steps at each stage of evaluation. IPEC developed the guidelines based upon "the best currently available toxicological science," according to a draft. Consideration was given to regulatory requirements as well as the deliberations of the International Conference on Harmonization. Following publication, IPEC will consider the comments it receives from the industry.

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