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Hot melt extrusion based solid solution approach: Exploring polymer comparison, physicochemical characterization and

Ritesh Fule1, Vivek Paithankar2, Purnima Amin3

  • 1Department of Pharmaceutical Sciences and Technology, Institute of Chemical Technology, Nathalal Parekh Marg, Matunga, Mumbai 400019, Maharashtra, India; Faculty of Pharmaceutics Department, H.K. College of Pharmacy, Relief Road, Oshiwara, Jogeshwari West, Mumbai 400102, Maharashtra, India.

International Journal of Pharmaceutics
|January 10, 2016
PubMed
Summary

This study developed amorphous solid solutions (SSL) of artesunate (ARS) using hot-melt extrusion, significantly enhancing drug release. Formulations with Soluplus and Kollidon VA64 showed dramatically increased bioavailability compared to pure ARS.

Keywords:
(2)D NMRArtesunateAtomic force microscopyBioavailabilityDissolutionHot melt extrusionsolid solution

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Area of Science:

  • Pharmaceutical Technology
  • Materials Science
  • Drug Delivery Systems

Background:

  • Artesunate (ARS) is a water-insoluble drug with poor oral bioavailability.
  • Continuous manufacturing methods like hot-melt extrusion (HME) offer advantages for drug formulation.
  • Developing amorphous solid solutions (SSL) can improve the dissolution and bioavailability of poorly soluble drugs.

Purpose of the Study:

  • To develop amorphous solid solutions (SSL) of artesunate (ARS) using hot-melt extrusion (HME).
  • To investigate the effect of excipients (Soluplus, Kollidon VA64) and additives on the HME process and drug properties.
  • To evaluate the drug release and pharmacokinetic profile of the developed SSL formulations.

Main Methods:

  • Powder blends of ARS with Soluplus (SOL) or Kollidon VA64 (VA64) and additives were processed using hot-melt extrusion.
  • Characterization techniques included Differential Scanning Calorimetry (DSC), X-ray Diffraction (TXRD), Scanning Electron Microscopy (SEM), Raman Spectroscopy (RS), Raman Imaging (RI), Atomic Force Microscopy (AFM), and NMR.
  • In vitro drug release studies and pharmacokinetic analysis (AUC, Cmax) were performed.

Main Results:

  • Hot-melt extrusion successfully produced amorphous solid solutions (SSL) with homogeneous drug distribution.
  • Surfactants and plasticizers facilitated smooth extrusion and controlled melt flow.
  • SSL formulations exhibited significantly faster ARS release compared to the pure drug.
  • Soluplus-based SSL showed 66.44x higher AUC(0-72) and 16.60x higher Cmax; Kollidon VA64-based SSL showed 62.20x higher AUC(0-72) and 13.40x higher Cmax.

Conclusions:

  • Hot-melt extrusion is an effective continuous manufacturing method for developing amorphous solid solutions (SSL) of artesunate.
  • The developed SSL formulations significantly enhance the bioavailability of artesunate.
  • The choice of excipients and additives plays a crucial role in optimizing the HME process and drug performance.