Abstract

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

Dhunaiselvam Dhunaibalan, Saravanan Elangovan, Vigneshwar Raju*

ABSTRACT

Cardiovascular issues caused by heart failure calls forefficacious combination therapy (ECT) to enhance patienthealth outcome of care and reduce disease burden. The fixeddoseLP of sacubitril and valsartan are clinically relevant due totheir complementary mechanisms by improving cardiacfunction. The present study was suitably designed to formulateand characterize immediate-release fixed dose combinationtablet of sacubitril and valsartan by direct compression method.The aim of this research was to provide a formulation that wasstable, effective and patient-friendly. The preformulationstudies involved evaluating the organoleptic properties, flowcharacteristics, solubility, drug and excipients compatibility.The purpose of the study was to develop glimepiridedispersible tablets using crospovidone, and the effects ofdiltuents on tablet properties were investigated. The formulatedproducts were analyzed for their flow properties and then weighed for weight variation,hardness, thickness, friability, disintegration time, assay and in-vitro dissolution. The precompressionand post-compression of all the formulations were found to be acceptable. The optimized formulation had a rapid disintegration time, good mechanical strength, and morethan 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.

Keywords: Sacubitril, Valsartan, Fixed dose combination tablets, Direct compression technique, In-vitro evaluation, Heart failure.