FORMULATION AND DEVELOPMENT OF EXTENDED RELEASE MATRIX PELLETS OF WATER INSOLUBLE AZILSARTAN MEDOXOMIL WITH SOLID DISPERSION

The present study involved the design and development of extended release matrix pellets of azilsartan medoxomil with its solid dispersion (Azil SD). A solid dispersion of azilsartan medoxomil was prepared with a carrier, Hypromallose acetate succinate (Affinisol 716G) by solvent evaporation technique. Extended release matrix pellets were prepared from Azil SD using a combination of polycarbophil, HPMC K4M, MCC and guar gum. AzilSD and the pellets were evaluated for various physicochemical properties such as solubility, drug loading, drug content, surface morphology and swelling behaviourand analysis carried out using Fourier transform infrared spectroscopy, differential scanning calorimetry and powder X-ray diffraction. The solubility and dissolution rate of Azil SD was 5.71 and 2.07 times greater, respectively.The optimized batch was selected based on 100% cumulative drug release in 12 hours. Formulation Batch F6 showed 99.19% CDR in 12 hours and drug content 97.89 %. The mechanism of the drug release rate kinetics of the Batch F6 followed the Korsmeyer-Peppas. Thus it can be concluded that Affinisol 716G based solid dispersion mechanism, enhances the solubility and dissolution of azilsartan medoxomil by using polycarbophil and HPMC K4M, forming an effective carrier for developing extended release matrix pellets.