A Novel Rosuvastatin Calcium Cow Ghee Fraction Biform Complex: Formulation Characterization and Evaluation

Background: Rosuvastatin calcium is a statin class of drug having limited oral bioavailability of about 20%. Bioavailability can be enhanced by using a biform complex of the drug with cow ghee. Methods: A precise thermal fractionation technique was adopted to separate different fatty acids from cow ghee. The collected fraction was characterized for fatty acid content. LC-MS and FTIR confirm the content variation in the collected fraction. Biform complex was prepared by fusion method with a constant ratio of drug and cow ghee fraction. The prepared complex was subjected to FTIR, DSC, and LC-MS studies to confirm chemical composition characteristics. For evaluation of the drug content, in-vitro and ex-vivo permeation studies were also performed. The antiinflammatory response was measured using the carrageenan paw-induced edema rat model. To determine the lipid-lowering effect, inflammation marker analysis was also performed using ELISA specific kit. Results: The biform complex prepared with a thermal fraction at 30°C of cow ghee showed the highest in-vitro and ex-vivo permeation. The anti-inflammation response of the biform complex F1 was higher than other tested formulations with a significant decrease in lipid and lipoprotein content. Conclusion: This study confirms that the thermal fractionation method is able to separate cow ghee as per the fatty acid content. The complexion of rosuvastatin calcium with cow ghee thermal fraction could enhance the oral bioavailability and improve anti-inflammatory and lipid-lowering activities.