An excipient is a substance formulated alongside the active ingredient of a medication,[1] included for the purpose of long-term stabilization, bulking up solid formulations that contain potent active ingredients in small amounts (thus often referred to as "bulking agents", "fillers", or "diluents"), or to confer a therapeutic enhancement on the active ingredient in the final dosage form, such as facilitating drug absorption,[2][3] reducing viscosity,[4] or enhancing solubility.[5] Excipients can also be useful in the manufacturing process, to aid in the handling of the active substance concerns such as by facilitating powder flowability or non-stick properties, in addition to aiding in vitro stability such as prevention of denaturation or aggregation over the expected shelf life. The selection of appropriate excipients also depends upon the route of administration and the dosage form, as well as the active ingredient and other factors. A comprehensive classification system based on structure-property-application relationships has been proposed for excipients used in parenteral medications.[6][7]
Pharmaceutical regulations and standards require that all ingredients in drugs, as well as their chemical decomposition products, be identified and shown to be safe. Often, more excipient is found in a final drug formulation than active ingredient, and practically all marketed drugs contain excipients.[1]:1 As with new drug substances and dosage forms thereof, novel excipients themselves can be patented; sometimes, however, a particular formulation involving them is kept as a trade secret instead (if not easily reverse-engineered).[citation needed]
The Excipients Industry Forum as a multi stake-holder forum and information hub for the wider excipients industry and the public. It’s goal is to promote open dialogue and partnership between the public, policy makers and the pharmaceutical industry.[8]
The Federation of International Pharmaceutical Excipients Council (IPEC),[9] a pharmaceutical regulatory non-profit, develops, implements, and promotes global use of appropriate quality, safety, and functionality standards for pharmaceutical excipients and excipient delivery systems. IPEC-Americas, along with its counterparts in Europe, China, and Japan serves as a primary international resource on excipients for its members, governments, and public audiences. IPEC works in collaboration with ExcipientFest to present topics ranging from regulatory affairs to research and development, often featuring speakers from FDA and other pharmaceutical organizations
