Sat, 18 Nov 2017

Preparation of Oxcarbazepine Solid Dispersion by Hot Melt Extrusion for Enhanced Dissolution: Downstream Processing to tablets

 

Sandip Chavan1, Ketan Patel1, Dnyanesh Shelar1, Pradeep Vavia1*

1.Department of Pharmaceutical Sciences and Technology, Institute of Chemical Technology,  University under Section 3 of UGC Act – 1956,  Elite Status and Center of Excellence – Govt. of Maharashtra, TEQIP Phase II Funded, Matunga (E), Mumbai - 19, India


 

ABSTRACT

Solid dispersion of Oxcarbazepine (OXC) was prepared by hot melt extrusion of OXC with hydrophilic polymer. The main objective was to explore the potential of Hot Melt Extrusion technique (HME) as an industrial scalable green technique for the preparation of solid dispersion and therefore enhancement of dissolution of poorly soluble drug. Polymer for extrusion was selected on the basis of solubility parameters and glass transition (Tg). OXC solid dispersion was prepared using Kollidon VA 64 and Soluplus as hydrophilic carrier. OXC and polymer was mixed in different ratio and extrudates were evaluated for appearance, DSC, PXRD, flow property and dissolution characteristics. DSC and PXRD studies revealed the significant reduction in crystallinity of OXC. OXC-kollidon VA 64 extrudates have good flow property having angle of repose 29° and carr’s index 11.2 and good compressibility with hardness 5-6 kg/cm2. Particle size of extrudates exhibited significant effect on disintegration time and dissolution. OXC release was found to be complete within 45 min from tablets of OXC hot melt extrudates while plain OXC showed just 39 % release. Solid dispersion of OXC was successfully developed using HME technology followed by formulating it into directly compressible tablets.

Keywords: Hot melt extrusion, Oxacarbazepine, Solid dispersion, Solubility enhancement, Glass transition temperature, Solubility parameter


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