WHAT ARE EXCIPIENTS?
1) An excipient is a crucial substance that is deliberately formulated alongside the active ingredient of a medication. It serves the purposes of ensuring long-term stabilization, bulking up solid formulations containing potent active ingredients in small amounts (often referred to as “bulking agents”, “fillers”, or “diluents”), or conferring a therapeutic enhancement on the active ingredient in the final dosage form. This can include facilitating drug absorption, reducing viscosity, or enhancing solubility.
2) Excipients play a vital role in the manufacturing process by assisting in the handling of the active substance, such as facilitating powder flowability or providing non-stick properties. They also aid in in vitro stability, preventing denaturation or aggregation over the expected shelf life.
3) The choice of suitable excipients is dependent on the route of administration and the dosage form, as well as the active ingredient and other relevant factors.
LAB TESTING OF EXCIPIENTS
1) Excipients are an indispensable part of pharmaceutical formulations, working in tandem with active pharmaceutical ingredients (APIs) to enhance stability, shelf life, and control drug release.
2)The absorption rate of dosage form pharmaceuticals is pivotal in determining their ability to dissolve and deliver pharmacological effects within the body.
ROLE OF EXCIPIENTS TESTING
1) Excipients, though technically inactive, play a crucial role in pharmaceuticals and are a major component of the final product. Testing is essential to understand how excipients affect drug absorption and optimize formulations for desired therapeutic effects. Some excipients slow drug dissolution to prevent tissue damage, while others disintegrate rapidly for quick symptom relief.
2) Gel permeation chromatography (GPC) is commonly used to test polymeric excipients, but a flexible approach is needed due to the wide variety of available excipients.