Preparation of Simvastatin-β-Cyclodextrin inclusion complexes using coevaporation technique

Maria Dona Octavia, Auzal Hali

Abstract

Preparation of simvastatin-β-cyclodextrin inclusion complexes has been performed using co-evaporation technique. The aim of this study is to characterize the inclusion complexes of simvastatin - β - cyclodextrin and improve the solubility and dissolution rate of simvastatin. For comparison, pure simvastatin and its physical mixture were used. Characterizations of inclusion complexes of simvastatin with β - cyclodextrin in a solution state were carried out using phase solubility studies. Characterizations of solid inclusion complexes were performed using differential Thermal Analysis (DTA), powder X-ray diffraction, and scanning electron microscopy (SEM). Dissolution profiles were performed in a medium of pH 7.0 phosphate buffer solution containing sodium lauril sulfate 0.5% using type II USP apparatus. The results of solubility phase test showed a diagram of type AL solubility, with a constant value of stability of 227.827 M-1, indicating that an inclusion complex of simvastatin - β - cyclodextrin (1: 1 molar) has been formed. The study results of dissolution rates and solubility showed that the inclusion complexes of simvastatin and β - cyclodextrin increased significantly in comparison to that of pure simvastatin and its physical mixtures.