Process induced degradation of carbamazepine during hot melt extrusion

Abstract

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

Keywords

Carbamazepine, Iminostilbene, Hot-melt extrusion, HPLC

How to Cite

Bose, S., Paradkar, A., Kelly, A. & Magam, H., (2023) “Process induced degradation of carbamazepine during hot melt extrusion”, British Journal of Pharmacy 8(2). doi: https://doi.org/10.5920/bjpharm.1392

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Authors

Sarbamangala Bose (University of Bardford)
Anant Paradkar orcid logo (University of Bradford)
Adrian Kelly (University of Bradford)
Harika Magam (University of Bradford)

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Creative Commons Attribution 4.0

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This article has been peer reviewed.

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