Excipient Functionality

Excipient functionality” is one of the latest buzz phrases, but it is frequently used by those who have little understanding of the particular nature of excipients. Excipients are not active pharmaceutical ingredients (APIs) and they do not treat medical conditions. But without them, the therapeutic revolution of the past 50–60 years could not have occurred. The watchwords for APIs and finished products are—and rightly so—safety and efficacy. Although the emphasis on APIs and analytical chemistry has resulted in many very good methods for assay development and the determination of purity (including impurities), it is clear that we still lack the understanding and the means to determine why some materials behave in certain ways when included in a formulation (i.e., their functionality).

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