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Excipient: Relative Versus Absolute Inactivity Types

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Excipient - Wikipedia 4/2/21, 5(37 PM

Excipient
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).

The Excipients Industry Forum as a multi stake-holder forum and information hub for the wider
excipients industry and the public. Its 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.[10]

Contents
Relative versus absolute inactivity
Types
Antiadherents
Binders

https://en.wikipedia.org/wiki/Excipient Page 1 of 8

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