Formulation Development Optimization and Stabilization of Olmesartan Medoxomil Immediate Release Tablet for Hypertension

Abstract

Drug XYZ a potential angiotensin II receptor blocker helps in modulating hypertension. The vasoconstriction effect of rennin-angiotensin system and aldosterone release is antagonised, thereby reducing blood-pressure. The objective of the present study was formulation and stabilization of an immediate release tablets of an anti-hypertensive drug, Drug XYZ. The tablets were prepared by wet granulation techniques, optimized for hardness, disintegration time, % dissolved in 45 minutes and the results were found comparable to when compared to innovator product. The optimization batch was checked for stability tests which failed in related compound A. The reason for impurity was evaluated and modifications were made in the method with respect to levels of magnesium stearate, type of coating and addition of free radical scavenger. Using wet granulation method and required modifications immediate release tablets were prepared and checked for significant properties. The optimized batch was found superior to innovator product in all aspects. The stability test was performed and observed acceptable. The optimized stable batch of Drug XYZ immediate release tablets showed a hardness of 16 -18 kg/cm2 identified with Monsanto hardness tester. The tablets disintegrated in 40 seconds and showed a dissolution upto 93 % in 45 minutes. The total impurity in the tablets were found to be 0.59 %. Thus, present study concludes that developed formulation is promising in treatment of hypertension.