Preparation, Physicochemical Characterization, Dissolution and Formulation Studies of Immediate release tablets of Amlodipine Besylate and Hydrochlorothiazide

The main goal of this study was to develop a stable formulation of antihypertensive drugs amlodipine and hydrochlorothiazide (HCTZ) as an immediate release tablet and to evaluate the dissolution profile. The formulation development work was initiated with wet granulation. Lactose monohydrate and microcrystalline cellulose were used as diluents. Starch paste is prepared in purified water and was used as the binder. Sodium starch glycollate is added as a disintegrating agent. Magnesium stearate was used as the lubricant. Disintegration time and drug release were taken as the basis to optimize the formulation. The prepared granules were compressed into a single layer compression machine. Capping was observed in the formulation F1. However, in the remaining four formulations no capping was observed. The tablets thus formulated with higher proportion of sodium starch glycollate showed satisfactory physical parameters, and it was found to be stable and in vitro release studies showed that formulation F5 was 101.03% for amlodipine and 99.14% for hydrochlorothiazide respectively. The results suggest the feasibility of developing immediate release tablets consisting of amlodipine and hydrochlorothiazide for the convenience of patients with hypertension.