2025 Fall
International Convention of PSK

D+7
October 22-24, 2025

Abstracts

P11-8

​A novel strategy for dissolution enhancement: development of fenofibrate immediate-release tablets by leveraging drug solubilization within the binding solution​

  • Hye-Yeon Nam1, Young-Eun Kim1, Joo-Eun Kim*2
  • 1Department of Biopharmaceutical Chemistry, Kookmin University, Seoul, Republic of Korea. 02707
  • 2Biopharmaceutical Chemistry Major, School of Applied Chemistry, Kookmin University, Seoul 02707, Korea

The purpose of this study was to evaluate the impact of drug mixing strategies, including solubilization of fenofibrate in the binder, on the development of immediate-release tablets of fenofibrate, a lipid-lowering agent for hyperlipidemia, and to identify optimal formulation conditions for enhanced dissolution. Fenofibrate is a BCS Class II drug with low water solubility, and the dissolution of its immediate-release tablets is influenced by excipient type and proportion as well as key manufacturing variables such as granulation method, binder composition, and drug incorporation strategy. In this study, tablets were prepared by wet granulation using different binder-to-solvent ratios and solubilization approaches, in which fenofibrate was partially or fully dissolved in the binder to improve dispersion and potential bioavailability. Dissolution tests conducted under standardized conditions were used to assess the release profiles of the formulations. Results demonstrated that binder type and drug mixing strategy significantly affected dissolution rate, uniformity of drug release, and overall tablet performance, and that applying the optimal combination improved dissolution. This study underscores the importance of binder selection and drug solubilization strategies in the development of fenofibrate immediate-release tablets and provides practical guidance for formulation optimization and generic product development.


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