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Updated: Jul 23, 2025

A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients
Published on: August 9, 2022
A comprehensive review on pharmaceutical excipients
Rachana D Pockle1, Rajashree S Masareddy1, Archana S Patil1
1Department of Pharmaceutics, KLE College of Pharmacy, KLE Academy of Higher Education & Research, Nehru Nagar, Belagavi, 590010, Karnataka, India.
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.
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