DESIGN AND EVALUATION OF CANDESARTAN CILEXETIL SOLID DISPERSION INCORPORATED IN HARD GELATIN CAPSULE

Candesartan cilexetil is widely used for the treatment of hypertension. Candesartan cilexetil is a pro-drug administered orally, rapidly converted to its active metabolite candesartan during absorption in the gastrointestinal tract. Candesartan cilexetil is a BCS II drug that is practically insoluble in the water of 0.00771 mg/ml & it has a low dissolution rate, hence; to improve dissolution rate & bioavailability, solid dispersion of Candesartan cilexetil were prepared by kneading method, solvent evaporation method & Microwave method in 1:0.5, 1:1 & 1:1.5 ratios of Candesartan cilexetil and hydroxy propyl beta-cyclodextrin /PVP K 30. Further, the SDs were filled into empty hard gelatin capsules with excipients like starch (8%), lactose, talc & Aerosil by manual capsule filling method. The formulated solid dispersions were evaluated for drug content and in-vitro dissolution studies. Accelerated stability studies was conducted for the optimized SD formulations, the optimized drug & carrier SD were confirmed & characterized by FT-IR. The drug content of the prepared Candesartan cilexetil SD formulations was found to be range from 94.35±0.95% to 98.44±0.56%.XRD studies showed that the drug exists in an amorphous state as there was no drug peak in the formulation. The solid dispersion of Candesartan cilexetil prepared by kneading method with HPβCD (1:1.5) showed a maximum drug release of 94.05±0.11% compared to other solid dispersion formulations. It is concluded that the dissolution rate of Candesartan cilexetil can be improved by the solid dispersion method.