Preparation and characterization of rufinamide HP-β-cyclodextrin complexes prepared by the kneading method for solubility enhancement.
Keywords:
Cyclodextrins, Differential Scanning Colorimetry, Hydroxy propyl β-cyclodextrin, kneading Method, RufinamideAbstract
Aims: The present investigation concerns the preparation and characterization of Rufinamide HP-β-cyclodextrin complexes prepared by the kneading method.
Material & methods: Rufinamide was procured as a gift sample from Torrent Pharmaceuticals limited. HP-β-cyclodextrin (HP-β-CD) was purchased from Himedia, India. Methanol and Hydrochloric Acid were purchased from S. D. Fine Chem. Pvt. Ltd., India. kneading method was selected to prepare inclusion complexation of Rufinamide. Phase solubility study was performed to check formation of inclusion complex. Prepared complex were characterize by different methods like DSC study, FTIR study, X-RPD study & in-vitro dissolution study.
Results: It was found that there is a formation of 1:1 inclusion complex between HP-β-CD as stability constant was found to be 221.27 M-1. DSC study, FTIR study had given supporting data for formation of inclusion complex. Amorphous nature of the complex was confirmed from the X-RPD study.
Conclusions: From in-vitro dissolution study it was found that 1:1.5 complex showed around 50% drug released in 30 min & more than 70% of Drug release in 60 mins.
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