FORMULATION AND EVALUATION OF NANOPARTICLES OF HMG -CoA REDUCTASE INHIBITOR.

Poor water solubility has been attributed to almost half of the 150,000 new molecular entities (NMEs) synthesized annually by pharmaceutical companies, and is also claimed to reduce the performance of more than 10% of successfully marketed drugs. Nanocrystal technology has become the fastest selling drug in the transplant market. Nanotechnologies offer new ways to address these drug delivery challenges and are being applied in a wide range of healthcare settings. Simvastatin is a poorly soluble lipidlowering agent. Its Water solubility is very low, approximately 30 μg/mL and poorly absorbed from the gastrointestinal (GI) tract. This work is an attempt to overcome the poor solubility and dissolution rate of simvastatin by using Nanosuspension technology. PVP and Tween 80 with Soybean Lecithin were used at different ratios as the surfactants. The formulations were done by Emulsion-solvent evaporation method followed by freezedrying. The formulated nanoparticles were subjected to characterization studies like Particle size analysis, X-ray diffraction studies, Differential Scanning Colorimetry, Scanning electron microscopy and UV analysis. The dissolution test of tablets containing the nanometric drug flakes revealed that, within 30 minutes, 89.76% (w/w) of the simvastatin in the tablet was dissolved. In comparison, the dissolution test of the conventional tablets revealed that under these testing conditions only 45.97% (w/w) simvastatin was dissolved. This result demonstrates the significant advantage of simvastatin nanoparticles over the conventional particulate drug and the feasibility of the proposed method. [ABSTRACT FROM AUTHOR]