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WHAT ARE EXCIPIENTS?

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  • An excipient is a substance formulated alongside the active ingredient of a medication, 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, reducing viscosity, or enhancing solubility.
  • 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.
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LAB TESTING OF EXCIPIENTS

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  • Excipient materials are generally formulated alongside APIs to promote improved thermodynamic stability, longer shelf-lives, control pharmacokinetics and control drug release rates.
  • The absorption capacities of dosage form pharmaceuticals can determine the rate at which they move from dissolution in vivo into the bloodstream, where they begin to exert pharmacological effects.

ROLE OF EXCIPIENTS TESTING

Although technically inactive, excipients perform a key role in dosage form pharmaceuticals, often comprising the bulk of the finished product. Pharmaceutical lab testing is conducted to assess how excipients affect the assimilation process of the APIs to optimize recipes for desired therapeutic effects. Some excipients may be required to slow dissolution for drugs where a rapid release could damage tender tissues and cause internal irritation. Others are made to disintegrate quickly, providing fast relief from symptoms.

GPC is often used to test polymeric excipients as the rate of drug release is often directly correlated to polymer molecular weight. However, the enormous range of readily available excipients (small molecule and polymeric) demands a flexible mindset when it comes to excipient lab testing.

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