Raju Balaji Reddy
Research Scholar, Department of Pharmacy, Sun Rise University, Alwar, Rajasthan, India.
Dr Vinod Nakra
Professor, Department of Pharmacy, Sun Rise University, Alwar, Rajasthan, India.
Dr. Manmeet Singh Saluja
Professor, Department of Pharmacy, Sun Rise University, Alwar, Rajasthan, India.
Abstract
Introduction: Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of HMG-CoA reductase, the rate- limiting enzyme that converts 3-hydroxy-3-methyl-glutaryl- coenzyme A to mevalonate, a precursor of sterols, including cholesterol.
Methodology: The Determination of Calibration curve by UV visible spectrophotometer and Analytical method validation by UV visible spectrophotometer. The Analytical Techniques Used to Detect Drug-Excipient Compatibility of drug.
Aim: The aim of this study was to design, formulate, and characterize the atorvastatin calcium loaded nanosponges (NSGs) by using a suitable factorial design.
Results and Discussion: The in vitro release profile of ATRC, Marketed tablet, lyophilized ATRC-NSGs in phosphate buffer pH 6.8 at 37°C shown in Fig IA. 71-72. The % drug release was not identical for all the batches. Initially the NSGs showed immediate release of ATRC, this may be due to release of drug from the surface of NSGs, followed by slow and controlled release of drug which was encapsulated in nanosponges.
Conclusion: Formulated nanosponges formulation was found to be stable at accelerated stability conditions as per ICH guidelines up to 6 months. Comparative in-vivo pharmacodynamic study (which was done as per approved protocol by CPCSEA committee) in male Wistar rats at fasted and fed conditions reveled that, formulated nanosponges successfully evade variation in optimized freeze dried ATRC-NSGs which showed better lessening in prominent level of TG, TC, LDL as well as VLDL and better improvement in HDL level.
Keywords: Atorvastatin calcium, nanosponges, ICH guidelines, in-vivo pharmacodynamic study, TG, TC, LDL.