Additives and Processing Aids in Pharmaceutical Excipients

Abstract

There are a large number of excipients in approved medicines that contain undeclared additives, processing aids, and/or concomitant components. [...]because these components had not been disclosed in the past, and because pharmaceutical manufacturers are analyzing for and finding these components due to advances in analytical techniques, it is not well understood if these components have been added intentionally or in the case of concomitant components, are inherent to excipient composition and are not impurities. [...]their presence in pharmaceutical products poses no risk to patient safety. [...]stakeholders, USP, and FDA, need to collaborate and develop a path forward that would affect the following: * Ensure that identification of low levels of additives and processing aids in established excipients does not lead to pharmaceutical products being deemed adulterated and/ or misbranded. * Ensure that excipients containing additives and/or processing aids comply with revised USP requirements (as proposed). * Create a means to share the above information in a manner that does not compromise excipient manufacturer's intellectual property.