A Novel Rosuvastatin Calcium Cow Ghee Fraction Biform Complex: Formulation Characterization and Evaluation
Vijendra Kumar Suryawanshi, Khomendra Kumar Sarwa, Suhas Narayan Sakarkar, Chanchal Deep Kaur · Drug Delivery Letters · 2021
Background: Rosuvastatin calcium is a statin class of drug having limited oral bioavaila-bility 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 anti-inflammatory response was measured using the carrageenan paw-induced edema rat model. To de-termine 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 con-tent. Conclusions: 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 frac-tion could enhance the oral bioavailability and improve anti-inflammatory and lipid-lowering activi-ties.