Development and Characterisation of Simvastatin Loaded Chitosan Nanoparticles for Sustained Drug Delivery

AIM AND PLAN OF WORK:To formulate Simvastatin loaded Chitosan Nanoparticle To carry out the Characterization of Simvastatin Nanoparticles Identification and confirmation of purity of drug by UV Spectrophotometry. Pre-formulation studies Drug polymer compatibility studies Evaluation of Nanoparticles Entrapment efficiency, Loading efficiency, Percentage yield, Drug content, Solubility studies, Drug particle size analysis by SEM, In-vitro drug release studies, In-vivo studies of nanoparticles as per the CPCSEA guidelines.SUMMARY AND CONCLUSION:The present work involves the formulation development, optimization, in-vitro and in-vivo evaluation of Simvastatin loaded Chitosan nanoparticles for sustained release. The Simvastatin, Chitosan were found to be compatible in FTIR study and DSC studies. The Simvastatin Nanoparticles were prepared by Nanoprecipitation method. Various concentration of chitosan were used to prepare Simvastatin nanoparticles and the maximum drug loading was found in F3. SEM study showed that prepared nanoparticles were spherical in shape with a smooth surface. Particle size of prepared nanoparticles was found to be in the range between 360nm and 480nm. In-vitro drug release of the optimized formulation shows 95.66% release at the end of 12 hours. The release kinetics of the optimized Nanoparticles showed that it follows zero order release kinetics. The release of the drug from Nanoparticles was found to be by diffusion and Non-fickian release. Stability studies of optimized nanoparticles were carried out according to ICH guidelines. It indicated that the Nanoparticles are stable and does not show any significant changes physical characteristics, drug content and dissolution. The comparative in vivo hypolipidemic activity performed on albino rats, after 21days of treatment, showed that plasma CH and TG levels were significantly lower (98.34±0.596 mg/dl, 84.56±0.55 mg/dl respectively) (p < 0.01). HDL-CH levels were significantly higher (36.29±0.602 mg/dl, p