DESIGN AND DEVELOPMENT OF SIMVASTATIN FLOATING TABLETS FOR CONTROLLED RELEASE

Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. 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. Floating tablets of Simvastatin were developed by direct compression method to increase the gastric retention time using HPMC K4M, Carbopol and sodium CMC polymers used and the mixture of the sodium bicarbonate, citric acid anhydrous as gas generating agents. The results of Pre-compressional and post-compression parameters were within IP prescribed limits. All the formulations (FB1-FB10) prepared the formulations FB1, FB2 and FB8 fails to float. Among all the formulations batch FB7 was the best formulation which showed buoyancy lag time 2 min and the tablet remained buoyant for 12hrs. The floating capacity increased in these formulations and floated with less lag time due to the high concentration of gas generating agent sodium bicarbonate. DSC and FTIR 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 FB7 was the best formulation retained for longer periods of time in the stomach and provides controlled release of the drug and may improve bioavailability.