Paper Key : IRJ************138
Author: Shailaja Pashikanti,Chintakayala Triveni,G. Sneha Latha
Date Published: 03 Dec 2024
Abstract
Excipients are known to be pharmacologically inert, plays a vital role in the formulation of medications. Inert substances called excipients are added to drugs in order to improve formulations or the therapeutic effects of active pharmaceutical ingredients (APIs) in the final dose form. As such, an active substance and an additive are present in practically in all medicinal products. Scientists studying about pharmaceutical excipients have demonstrated over time that excipients are not inert and can affect the quality, safety, and efficacy of prescribed medications when taken as indicated. Today, with adverse affects patient outcomes from pharmaceutical excipient adulteration, pharmaceutical businesses and regulatory agencies view control over excipient distribution and manufacturing as a key concern. Because they maintain the efficacy, safety, and functioning of the active pharmaceutical ingredients (APIs), which are found in almost all marketed medications, excipients are essential to the pharmaceutical production process. This study aims towards the regulatory aspects of pharmaceutical excipients and their function in dosage forms, with a focus on excipient qualification for use, novel excipient regulations, challenges, and the role of the International Pharmaceutical Excipients Council (IPEC) in regulating excipient quality in the European Union (EU).
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