DISSOLUTION RATE ENHANCEMENT OF ATORVASTATIN, FENOFIBRATE AND EZETIMIBE BY INCLUSION COMPLEX WITH β-CYCLODEXTRIN

Dissolutionrate of inclusion complex of Atorvastatincalcium (AT) (10.23mg equivalent to 10mg of Atorvastatin), Fenofibrate(FE) (160mg) and Ezetimibe(EZ) (10mg) with β-cyclodextrin (β-CD) were investigated. The phase solubility profiles of AT, FE and EZ with β-CD were classified as ALtype, which indicated the formation of 1:1 stoichiometry inclusion complexes. Stability constants with 1:1 molar ratio obtained from the phase solubility diagrams were 550.60 M-1, 2020.61 M-1 and 1604.05 M-1 for AT, FE and EZ respectively. Quaternary systems of AT, FE and EZ with β-CD prepared by kneading and co-evaporation method were characterized by Differential scanning calorimetry (DSC) and X-ray powder diffractometry (XRD). The dissolutionprofiles of inclusion complexes were determined and compared with those of AT, FE and EZ and physical mixtures with βCD. The dissolutionrate of AT, FE and EZ were increased by β-CD inclusion complexation. Highest dissolutionrate was obtained by co-evaporation method followed by kneading method. However, the dissolutionrate were increased significantly (p < 0.05) by co-evaporation method compared to kneading method.