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An innovative carrier for the formulation of amorphous solid dispersion by hot-melt extrusion with no further downstream processes: a case study with indomethacin.

Authors
  • Lacerda, S P1
  • Del Confetto, S1
  • Haurie, L1
  • Bernard, M2
  • Faget, S2
  • Ré, M I1
  • 1 Centre RAPSODEE, Université de Toulouse, Albi, France. , (France)
  • 2 Research and Development, Seppic, Paris, France. , (France)
Type
Published Article
Journal
Pharmaceutical development and technology
Publication Date
Feb 01, 2024
Volume
29
Issue
2
Pages
131–142
Identifiers
DOI: 10.1080/10837450.2024.2306802
PMID: 38235570
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

The aim of this work was to study the possibility to use SepitrapTM as a carrier for the formulation of amorphous solid dispersions by HME (hot melt extrusion) processing aiming solubility enhancement of poorly water-soluble drugs. SepitrapTM is a microencapsulated powder solubilizer designed to simplify the manufacture of drugs in oral solid forms, not yet tested for this purpose. The performance of SepitrapTM was evaluated in HME processing for amorphous solid dispersions of poorly-water soluble drugs with indomethacin as a model drug. The study was conducted using a twin-screw extruder, two compositions of SepitrapTM and different loads of indomethacin, demonstrating that SepitrapTM could represent a new range of carriers for amorphous solid dispersions for HME processing, reducing necessary downstream steps such as grinding.

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