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

Abstract

The aim of this work was to study the possibility to use Sepitrap^TM as a carrier for the formulation of amorphous solid dispersions by HME (hot melt extrusion) processing aiming solubility enhancement of poorly water-soluble drugs. Sepitrap^TM 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 Sepitrap^TM 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 Sepitrap^TM and different loads of indomethacin, demonstrating that Sepitrap^TM could represent a new range of carriers for amorphous solid dispersions for HME processing, reducing necessary downstream steps such as grinding.

Keywords:

• Amorphous solid dispersions (ASDs;), Sepitrap^TM
• stability
• hot melting extrusion
• solubility enhancement
• dissolution

Acknowledgements

The authors are grateful to P. Accart, L. Devrient, V. Nallet and C. Rolland from Rapsodee Center for respectively particle size, dissolution tests, XRPD analyses and SEM images and to Gala Platform Team for extrusion tests.

Disclosure statement

No potential conflict of interest was reported by the author(s). The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.

Additional information

Funding

Research reported in this publication was supported by SEPPIC S.A.