Abstract

The main goal of this study was to develop a stable formulation fo r two incompatible anti hypertensive drugs Amlodipine besilate and Losartan potassium as an immediate release bi layer tablet and to evaluate its dissolution studies. The formulation development work was initiated with wet granulation for losartan potassiu m layer and direct compression for amlodipine besilate layer. Super disintegrants like Crospovidone, Sodium starch glycolate (SSG) were used in all the formulations and its role on disintegration and dissolution properties of the drug were studied. The pre pared tablets were evaluated for weight variation, wetting time, hardness, thickness, friability, % drug content, disintegration time, in vitro drug release. Formulation F8 showed a highest drug release of 84.02 % for amlodipine besilate and 90.08 % for lo sartan potassium in 30 minutes which was selected as optimized formulation and considered for further studies. The stability studies, shown that the formulation F8 was stable enough at 40 ◦ C / 75 % RH for a period of 6 months. The results suggest the feasib ility of developing bi layer tablets consisting of amlodipine besilate and losartan potassium for the convenience of patients with hypertension.

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