Characterization of Thermal Fraction of Clarified Butter and its Applicability to Improve Bioavailability of Rosuvastatin

Abstract

Abstract: Aim: The present investigation shows confirmatory evidence for the complex formation of Rosuvastatin with a fraction of Clarified Butter. Material and Methods: Fractions of Clarified Butter prepared according to thermal behavior at different temperatures (30°C, 40°C, 50°C). Rosuvastatin biform complex with Clarified Butter in the ratio (1:1) and (1:2) w/w was prepared. Physicochemical properties of all fractions of Clarified Butter had determined as per Indian Pharmacopoeia. The fractions were subject to Fouriertransform Infrared spectroscopy (FTIR), Differential Scanning Calorimeters (DSC) and in-vitro release studies (Simulated gastric fluid, pH 1.2 for 2 h and simulated intestinal fluid, pH 6.8 for 6 h). Results: Based on these investigations; the optimized ratio (1:1) w/w were further characterized for DSC and FTIR studies. Where Rosuvastatin showed a strong carbonyl band at 1543.05 cm−1 , all fractions showed the disappearance of strong carbonyl band at 1543.05 cm−1, spectra of biform complex shifted to higher frequency 1747.51 cm−1 (13.29 % increase), that show carboxylic and hydroxyl group of both saturated and unsaturated fatty acid present in Clarified Butter. From in vitro release study the highest percent release i.e. 99.23±0.08% of Rosuvastatin was obtained from 1:1 biform complex. DSC thermogram confirming the formation of eutectic mixture by lowering the peak of pure Clarified Butter (67.4°C) to 58.10°C by the formation of biform complex with the drug Rosuvastatin. Conclusion: Thus, Clarified Butter and its fraction are prominent in improving the bioavailability of Rosuvastatin. Key words: Rosuvastatin, Clarified Butter, Peroxide value, Thermal oxidation, Bioavailability.