Formulation Characterization, Invitro, Invivo and Pharmacokinetic Evaluation of Stabilized Rosuvastatin Calcium Nanosuspension

Abstract

Rosuvastatin calcium is a BCS class II drug which is used as hyperlipidemic. Many of the BCS class II drugs offer the disadvantage of solubility. Nanoparticle compounds present a promising solution to the insolubility of BCS class II drugs. A simple and efficient technique for the preparation of nanoparticles is a precipitation technique. Polymeric nanoparticles have been prepared by employing the nanoprecipitation method. The nanosuspensions were made by using PVP K30, HPMC K15M, Eudragit L100 in various ratios using precipitation technique. DSC tests the compatibility between the drug and different ingredients. The formed nanoparticles were evaluated for multiple testing parameters like particle size, zeta potential, drug content and dissolution testing. Among all the formulations, the nanosuspension prepared with Eudragit L 100 showed better characteristics. The dissolution test showed the drug release for 12 hours. The best formulation showed the particle size of 100.5 ± 5.4 nm and zeta potential of -55.1 mv. The in vivo  studies on the Wistar rats showed better pharmacokinetic parameters when compared to the pure drug. Nano precipitation method was successfully employed to prepare Rosuvastatin calcium nanosuspension to improve the dissolution as well as bioavailability.