FORMULATION AND EVALUATION OF SUSTAINED RELEASE TABLETS OF DOXAZOSIN MESYLATE

The objective of the present investigation was to develop a sustained release (SR) tablets of Doxazosin Mesylate by wet granulation technique using a combination of synthetic polymers (Eudragit RS-100 and Eudragit RL-100). Different batches of Doxazosin Mesylate sustained release tablets were prepared by using microcrystalline cellulose as diluents by wet granulation technique. The compatibility of the drug and excipients was ruled out by FT-IR studies and found to be compatible. Granules of prepared batches were evaluated for their physical properties and found to be good and satisfactory. Tablets were evaluated for various physicochemical parameters like hardness, thickness, friability, weight variation test, drug content, and in-vitro drug release. To study the effect of concentration of polymers on drug release from SR tablets, 3² full factorial design was applied. The concentration of Eudragit RS-100 and Eudragit RL-100 were used as independent variables, while percentage drug release at 2 h and 22 h were selected as the dependent variable. Contour as well as response surface plots were constructed to show the effect of variables on % CDR and predicted that batch R1 containing Eudragit RS-100 (10 mg) and Eudragit RL-100 (10 mg) shows a maximum response. The kinetic release study showed that Korsmeyer equation had shown r² = 0.9984 which was close to one indicating that the dissolution profile fits in Korsmeyer-Peppas model and the mechanism of drug release from these tablets was by a non-fickian diffusion mechanism. The results of the accelerated stability study of final formulation for 1 month revealed that storage conditions were not found to have made any significant changes in final formulation.