DESIGN AND DEVELOPMENT OF SIMVASTATIN GASTRORETENTIVE TABLETS FOR CONTROLLED RELEASE

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. Gastroretentive Floating tablets of Simvastatin were developed by direct compression method using HPMC K15M, HPMC K100M, Carbopol, sodium CMC, xanthan gum, sodium alginate 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. The formulation FC1, FC2, FC3, FC4, FC5, FC6, FC8 floated but the lag time was more and floating time is less. For the formulation FC7, the duration of buoyancy was more than 12 hrs, the floating capacity increased in these formulations and floated with less lag time due to the high concentration of gas generating agent sodium bicarbonate-induced CO 2 generation in the pressure of dissolution medium (pH 1.2 0.1N HCL). The drug release from the formulations FC1-FC8 was found to be 78.612, 72.66, 87.22, 63.45, 67.26, 73.24, 98.93, and 81.27 in 12hrs. Among all the formulations FC7 floating lag time 7 min with 99% of drug release has better control release of the drug. 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 formulation retained for longer periods of time in the stomach and provides controlled release of the drug and may improve bioavailability. Keywords: Controlled Gastroretentive tablets, Simvastatin, HPMC, Carbopol.