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Designing starch-based fenofibrate formulations using the melting method.

Jeong Sun Sohn1, Ye Eun Choi2, Jin-Seok Choi3

  • 1Division of Interdisciplinary Studies, Chosun University, Ph.D, Associate Professor, Gwangju 61452, Republic of Korea.

International Journal of Biological Macromolecules
|June 7, 2024
PubMed
Summary

This study developed a fenofibrate (FNF) solid dispersion (SD) to improve drug solubility and stability. The optimal FNF-SD formulation significantly enhanced FNF dissolution rates compared to commercial products.

Keywords:
Dissolution percentageFenofibrateHyperlipidemiaLipidil®Melting methodStability

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Physical Pharmacy

Background:

  • Fenofibrate (FNF) is a poorly water-soluble drug used for hyperlipidemia.
  • Commercial FNF formulations, like Lipidil®, have high dosages (160 mg) due to poor solubility.
  • Developing enhanced FNF formulations is crucial for improving therapeutic efficacy.

Purpose of the Study:

  • To develop a fenofibrate solid dispersion (SD) to enhance solubility and stability.
  • To optimize the FNF-SD formulation using a melting method.
  • To evaluate the dissolution, physicochemical properties, and stability of the developed FNF-SD.

Main Methods:

  • Utilized the melting method for FNF-SD preparation, leveraging FNF's low melting point.
  • Evaluated FNF dissolution in various media (pH 1.2, distilled water, pH 6.8 buffer with SLS) at different time points.
  • Assessed physicochemical properties (melting point, crystallinity) and long-term stability (six months) of the optimal FNF-SD formulation.

Main Results:

  • The optimal FNF-SD (SD2) formulation demonstrated significantly increased FNF dissolution rates at 5 minutes compared to Lipidil® and pure FNF.
  • SD2 achieved nearly 100% FNF dissolution in all tested media within 60 minutes.
  • The SD2 formulation exhibited slight changes in FNF's melting point and crystallinity, with stability maintained for six months, particularly with starch#1500 inclusion.

Conclusions:

  • The developed FNF-SD formulation effectively enhances FNF dissolution due to weak drug-excipient binding.
  • The FNF-SD formulation demonstrates good stability, crucial for pharmaceutical applications.
  • The improved solubility and stability suggest promising outcomes for future in vivo studies.