Title:A Novel Rosuvastatin Calcium Cow Ghee Fraction Biform Complex: Formulation Characterization and Evaluation
Volume: 11
Issue: 4
Author(s): Vijendra Kumar Suryawanshi, Khomendra Kumar Sarwa*, Suhas Narayan Sakarkar and Chanchal Deep Kaur
Affiliation:
- Department of Pharmacy, Government Girls Polytechnic Raipur, C.G. 492001,India
Keywords:
Rosuvastatin calcium, cow ghee, thermal fractionation, biform complex, C-reactive protein, plasma fibrinogen,
anti-inflammation, clarified butter.
Abstract:
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.