Process Optimization and Evaluation of Immediate Release Tablet containing Benzimidazoles

Abstract

Olmesartan is an angiotensin II antagonist used in the treatment of hypertension. In present investigation an attempt was made to develop solid oral formulation of Olmesartan. The purpose of this study was to develop the formulation as immediate release tablet of Olmesartan by using excipients by design of experiment. Tablets were prepared by using direct compression method. In HPLC study of Olmesartan the correlation coefficient was found to be 0.993 at 296 nm at flow rate of 0.7 ml/min at injection volume of 5 L Tablets were evaluated for hardness, thickness, dissolution calibration study, drug content and all the in-vitro studies were performed using USP apparatus type II All in-vitro studies were carried out using Phosphate buffer at 37°C ± 0.5°C. The optimized formulation showed in- vitro drug release of 96. 80 % at the end of 60 min. Comparing to other ARB’s drug shows high affinity Angiotensin II type 1 (AT1) receptors has long duration of action. Olmesartan has longest half life of 24 hrs where, T max is 0.5 – 1 hr, and it was so rapidly achieving desired plasma concentrations. Stability studies were carried out according to ICH guidelines. All the results were obtained within given ICH limits.