ABSTRACT:
This study was aimed to formulate and evaluate sustained release matrix tablets of Olmesartan medoxomil using the release controlling polymers namely HPMC K15M, Eudragit RL and Eudragit RS for extended period release of drug and to enhance the patient compliance. For preformulation studies, absorption maximum (λmax), calibration curve, and FTIR compatibility analysis were performed. Olmesartan exhibited λmax of 257 nm and displayed good linearity (R² = 0.9938) and FTIR study revealed no significant drug–excipient interaction. Twelve formulations (B1 to B12) were prepared by direct compression method and the parameters of pre compression and post compression, in vitro drug release, and accelerated stability of the prepared formulations were evaluated. The flow property of all the formulations was found to be satisfactory and the values of weight variation, hardness, friability, thickness and drug content were also found to match the pharmacopoeial limits. In vitro dissolution studies revealed that the amount and molar ratio of Eudragit RL and Eudragit RS to both affect the release profile of the drug. Batch B8 yielded the best result, with high mechanical strength, complete drug content and 98.2 % cumulative drug release within 12 hrs in all the formulations. Optimized formulation was shown to be stable without significant changes in the physicochemical or the dissolution property through accelerated stability studies. The developed sustained-release matrix Olmesartan medoxomil tablet showed a good sustained-release profile with longer action and better therapeutic efficacy as well as better patient adherence.