Characterization Of Polymeric Hot-Melt Extruded Dosage Forms Including A New Polymer, Soluplus

Michael A. Repka1,2, Sindhuri Maddineni1, Sunil Kumar Battu1, Soumyajit Majumdar1,2, Karl Kolter3, Nigel Langley4.

1Department of Pharmaceutics, School of Pharmacy, The University of Mississippi, University, MS-38677, USA. 2National 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

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ABSTRACT 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.

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