FORMULATION DEVELOPMENT AND IN-VITRO EVALUATION OF FIXED DOSE COMBINATION OF SACUBITRIL AND VALSARTAN TABLETS

Cardiovascular issues caused by heart failure calls for efficacious combination therapy (ECT) to enhance patient health outcome of care and reduce disease burden. The fixed-dose LP of sacubitril and valsartan are clinically relevant due to their complementary mechanisms by improving cardiac function. The present study was suitably designed to formulate and characterize immediate-release fixed dose combination tablet of sacubitril and valsartan by direct compression method. The aim of this research was to provide a formulation that was stable, effective and patient-friendly. The preformulation studies involved evaluating the organoleptic properties, flow characteristics, solubility, drug and excipients compatibility. The purpose of the study was to develop glimepiride dispersible tablets using crospovidone, and the effects of diltuents on tablet properties were investigated. The formulated products were analyzed for their flow properties and then weighed for weight variation, hardness, thickness, friability, disintegration time, assay and in-vitro dissolution. The pre-compression and post-compression of all the formulations were found to be acceptable. The optimized formulation had a rapid disintegration time, good mechanical strength, and more than ninety percent drug release within forty-five minutes similar to marketed formulation. Accelerated storage condition stability studies exhibited no significant physical or chemical changes throughout the study period. The results of the study confirm that direct compression is a simple, economical, and reproducible method for the development of sacubitril and valsartan fixed dose combination tablets suitable for large-scale production.