FORMULATION AND EVALUATION OF SELEXIPAG AND EZETIMIBE BI-LAYER TABLET BY NOVEL APPROACH

Hypertension and hypercholesterolemia are two common diseases that often coexist. The combined presence of hypertension and hypercholesterolemia increases considerably the risk for cardiovascular complications.Selexipag is used to treat symptoms of pulmonary arterial hypertension and Ezetimibe is a lipid-lowering compound that inhibits intestinal cholesterol and phytosterols absorption.The bilayer tablets of antilipidemic and antihypertensive can be employed for the treatment of hypertension and hypercholesterolemia together through oral administration of single tablet. The rationale for this fixed?dose combination is to co-administer two drugs acting by different mechanisms of action together, reduce dosing frequency, and increase patient compliance.In the present investigation we combine Selexipag and Ezetimibe. Immediate release layer of Selexipag was formulated using various superdisintegrants like Crospovidone, Croscarmellose sodium, and sodium starch glycolate, Microcrystalline Cellulose, Magnesium Stearate and Extended release layer of Ezetimibe was formulated using polymers and gums like Hydroxy Propyl methyl cellulose,Poly vinyl Pyrrolidone, Talc, Gaur gum, and Xanthan gum, Magnesium stearate. The disintegration and dissolution study of both layers showed that inclusion of surfactant to the tablet formulation (Immediate Release) and dissolution medium (Extended Release) enhanced the release of drugs from both layers. Dissolution studies of optimized IR layer (SL6) and ER layer (EZ5) showed good dissolution. The above results reveal that the optimized immediate release layer Selexipag (SL6) and extended-release layer of Ezetimibe (EZ5) might be suitable for the treatment of hypertension and hypercholesterolemia by sequential release of the two drugs in a bilayer tablet