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Review
. 2023 Jul;14(7):443-458.
doi: 10.4155/tde-2023-0026. Epub 2023 Jul 18.

A comprehensive review on pharmaceutical excipients

Rachana D Pockle  1 , Rajashree S Masareddy  1 , Archana S Patil  1 , Pragati D Patil  1
Affiliations
Review

A comprehensive review on pharmaceutical excipients

Rachana D Pockle et al. Ther Deliv. 2023 Jul.

Abstract

The effectiveness of pharmaceutical drugs depends not only on their active components and manufacturing processes, but also on the role played by pharmaceutical excipients. The traditional definition of excipients as inactive and cost-effective substances has evolved significantly. They are now recognized as essential elements of drug formulations, constituting 80-90% of the final product. The rapid advancements in delivery systems, along with scientific, regulatory, financial and technological developments in biopharmaceutics, have generated renewed interest in the use and functionality of excipients, especially in solid dosage forms. This review focuses on the categorization of excipients according to the International Pharmaceutical Excipient Council (IPEC) and the establishment of guidelines for evaluating the safety of a new proposed excipient.

Keywords: IPEC; functionality; pharmaceutical excipient; pharmaceutical sector; safety guidelines; solid dosage forms.

Plain language summary

Excipients are matter we add to medicine when we make it. They give the medicine different qualities, like making it easier to dissolve, stick together, or slide smoothly. But if we use too many excipients, it can make the medicine less stable and more expensive. To avoid these problems, we can use special excipients that can do more than one thing. These multi-purpose excipients make the medicine work better, stay stable and cost less.

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