ABSTRACT:
Simvastatin is a Hypolipidemic used to control elevated cholesterol, or hypercholesterolemia. The primary uses of simvastatin are for the treatment of dyslipidemia and the prevention of cardiovascular disease. Gas powered Floating tablets of Simvastatin were developed by direct compression method using different grades of HPMC, Carbopol, ethyl cellulose, sodium CMC, sodium alginate, mixture of sodium bicarbonate, citric acid anhydrous as gas generating agents, Citric acid was also used as an antioxidant. The results of Pre-compressional parameters were within I.P prescribed limits. The prepared tablets were subjected to post compression analysis for the parameters such as hardness, friability, weight variation, thickness, diameter, drug content, lag time subsequently buoyancy time, and in-vitro dissolution studies. Tablets of all the formulation floated more than 12hrs. The results of in vitro buoyancy time and lag time study revealed that as the concentration of sodium bicarbonate increases there is increase in total buoyancy time and decrease in lag time. The results of dissolution study reveals that, a decrease in release rate of the drug was observed on increasing the polymer ratio and also by increasing the viscosity grades of the polymer. In all the formulations, hardness test indicated good mechanical strength, friability is less than 1%, indicated that tablets had a good mechanical resistance. DSC and FT-IR studies revealed that, there was no incompatibility of the drug with the excipients used. The stability study conducted as per the ICH guidelines and the formulations were found to be stable. From this study, it can be concluded that, the formulation retained for longer periods of time in the stomach and provides controlled release of the drug and may improved bioavailability.