Formulation and In-Vitro Evaluation of Simvastatin Floating Tablets by Direct Compression Method

In the present study we report, the various processing parameters and formulations aspects for developing a pharmaceutical equivalent, stable, cost improved and quality improved formulation of floating tablet of Simvastatin comparable with innovator and optimize certain process parameters to get maximum yield of the product during large scale manufacturing. Being a Class II drug, Simvastatin shows slow dissolution rate, limited oral absorption and high variability in pharmacological effects. Present study has been done for improving the absorption and its bioavailability in order to establish controlled floating drug delivery systems of Simvastatin. Fixed amount of gas generating agent ammonium bi carbonate and by using direct compression technique and it was noticed that the prepared tablets constantly found to be buoyant for more than 8 hours in the released medium. The results of dissolution studies indicated that the formulation F₁₈ is the most successful of the study. A decrease in release rate of the drug was observed on increasing polymer ratio. The optimized formula F₁₈ was fitted to various kinetic models and the result showed that F₁₈ batch followed Zero order kinetics. The mechanism of drug release from F₁₈ batch was anamolous non-fickian diffusion pattern.