Roundtable: Excipient Trends/Challenges

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Vivek Dave: Pharmaceutical excipients are broadly defined as, ‘"Any component other than the active principle added intentionally to the medicinal formulation." Thus, although by definition excipients are required to be pharmacologically inert, their use in drug products is ubiquitous. Excipients are used in virtually all pharmaceutical formulations and serve valuable function in one or more domains of drug product development. In a pharmaceutical formulation excipients are used mainly to improve processing (eg, improving powder flow), enhance aesthetics (eg, identification, branding, etc), optimize product performance (eg, modified drug-release), and/or to facilitate patient compliance (eg, taste masking). Over the years, the use of excipients has been driven by preformulation characteristics of the API, drugexcipient compatibility, processability, excipient cost, and marketing. Excipients find their origin in a variety of sources including plant, animal, mineral, biotechnology, and chemical synthesis. Hence, a majority of pharmaceutical excipients are supplied by food and chemical industries. The USFDA maintains a database of inactive ingredients (excipients) present in approved drug products. This database assists formulation scientists involved in the drug product development in a rational selection and use of excipients. A new excipient to be used in a drug product requires undergoing an extensive review process by the FDA to ensure safety in humans.

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