Abstract

The aim of this studywas to evaluate hot melt extrudates of carbamazepine(CBZ) for presence of process induced degradation product iminostilbene (IMB) and quantifying using highperformance liquid chromatography (HPLC). CBZ was used as model drug. Hot-melt extrusion (HME) was performed to preparesolid dispersions. Different grades of compatible polymers were used. Drug loading,processing temperature and screw rotations per minute (RPM) showed significanteffect on degradation of CBZ The extrudates were characterized by differentialscanning calorimetry (DSC), X-ray diffraction (XRD), Fourier transform infrared(FTIR) studies. DSC and XRD data confirmed formation of amorphous soliddispersions of CBZ. HPLC was performed to quantify percentage amount of CBZ andIMB. Process induced degradation was significantly varied depending on polymergrade and (w/w) percentage combinations. In addition, processing temperatureand RPM had direct effect on percentage of IMB formation. 

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