Abstract
A thousand different excipients can be used when formulating pharmaceuticals and, as a rough estimate, excipients can comprise more than 90% of a medicinal product's weight. Excipients are no longer characterized as simple inert additives to the API, and the need for stringent, quality management of excipients has grown rapidly. In 2010, FDA noted five drug recalls due to dissolution failures ascribed to excipients. In one case, FDA issued an import alert and an advisory to drug and dietary supplement manufacturers warning of high levels of peroxide in the excipient crospovidone manufactured in China. In the warning, FDA explained that drug manufacturers who used excipients containing high levels of peroxides would observe a loss of drug potency and the formation of excessive impurities during the product's shelf life. This article discusses how the supplier of pharmaceutical raw materials should take a central role in ensuring excipient quality.
