Characterization of Polymeric Hot-Melt Extruded Dosage Including a New Polymer, SOLUPLUS.

Year
2010
Authors
Michael A. Repka Sindhuri Maddineni, Sunil Kumar Battu, Soumyajit Majumdar Karl Kolter, Nigel Langley.
Institutions
Department of Pharmaceutics, School of Pharmacy, The University of Mississippi, University, MS-38677, USA. National Center for Natural Products Research, The University of Mississippi, University, MS-38677, USA. 3BASF SE, R&D Project Management Excipients, Ludwigshafen-67056, Germany. National Center for Natural Products Research, The University of Mississippi, University, MS-38677, USA. 4BASF Corporation, US HWY 46 W, Ledgewood, NJ-07852, USA. marepka@olemiss.edu
Summary

Solid dispersions containing Nifedipine as a bioactive, and Soluplus®, Kollidon® VA 64, and Eudragit® RS PO as the carrier matrices were produced utilizing a hot-melt extrusion (HME) technique. The extruded matrix formulations were characterized for their stability and in vitro release. DSC studies revealed that the dispersions produced by both, Soluplus® and Kollidon® VA 64 exhibited excellent physical stability at the end of 3 months when stored at 40°C/75% RH. Although, the drug release profiles of these extrudates were statistically similar (f2=74.71), their corresponding physical mixtures exhibited significantly different release patterns when compared to the hot-melt extruded dosage forms. The drug release from both, Soluplus® and Kollidon® VA 64 matrices was over 95%, whereas the Eudragit® RS PO matrices displayed a release of only 27.7%, at the end of 2 hours.