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A novel amorphous solid dispersion based on drug-polymer complexation.

Fan Meng1, Rui Ferreira2, Yongchao Su3

  • 1College of Pharmacy, The University of Texas at Austin, 2409 University Ave, TX, 78712, Austin, USA.

Drug Delivery and Translational Research
|November 5, 2020
PubMed
Summary
This summary is machine-generated.

Complexation of Rafoxanide (RAF) with povidone K25 (PVP) in amorphous solid dispersions (ASDs) significantly enhanced drug release and in vivo absorption. This formulation strategy improves solubility and bioavailability.

Keywords:
Amorphous solid dispersionDrug–polymer complexationIn vitro dissolutionIn vivo absorptionRafoxanideSpray drying

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Materials Science

Background:

  • Rafoxanide (RAF) exhibits poor water solubility, limiting its therapeutic efficacy.
  • Amorphous solid dispersions (ASDs) are a strategy to enhance the solubility and bioavailability of poorly soluble drugs.
  • Drug-polymer complexation can further improve the properties of ASDs.

Purpose of the Study:

  • To investigate the impact of Rafoxanide-povidone K25 (RAF-PVP) complexation on the in vitro and in vivo release of RAF.
  • To compare the performance of a complexation-based ASD with a traditional ASD formulation.
  • To elucidate the mechanisms behind the improved drug release from the complexation-based ASD.

Main Methods:

  • Preparation of two RAF ASDs via spray-drying: one complexation-based and one traditional.
  • Solid-state characterization using multiple techniques to confirm amorphous nature.
  • In vitro dissolution testing to assess drug release profiles.
  • In vivo absorption studies in an animal model.

Main Results:

  • Both spray-drying methods yielded amorphous solid dispersions (ASDs).
  • The complexation-based ASD demonstrated significantly faster in vitro drug release compared to the traditional ASD.
  • Higher in vivo absorption of RAF was observed from the complexation-based ASD in an animal model.

Conclusions:

  • RAF-PVP complexation in ASDs enhances both in vitro drug release and in vivo absorption.
  • The improved performance is attributed to the amorphous state, high microenvironmental pH, increased apparent solubility due to complexation, and enhanced wettability.
  • Complexation-based spray-drying is a promising approach for formulating poorly water-soluble drugs like Rafoxanide.