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;), SepitrapTM; dissolution; hot melting extrusion; solubility enhancement; stability.