Characterization and Development of SMDDS to Enhance Solubility of Azilsartan Medoxomil

Abstract

Enhance Solubility of Azilsartan Medoxomil SMDD formulations are isotropic mixture of oil, surfactant and co-surfactant. The Azilsartan medoxomil is lipophilic in nature. The oil, surfactant and co-surfactant were selected on the basis of solubility and emulsification ability. Castor oil tween 20 and carbitol were selected on the basis of solubility and emulsification ability. AM was formulated as a SMEDDS in an attempt to increase its solubility. The pseudo ternary phase diagram was constructed by using 1:1, 1:2 and 2:1 ratio of surfactant and co-surfactant with oil and distilled water. By this pseudo ternary phase diagram 1:1 ratio of surfactant and co-surfactant was more stable and good emulsification ability. The Box-Behnken design used for the statistical optimization of SMEDDS formulation using 3 factors and 2 levels and evaluated 3 response parameters emulsification time, % transmittance and % cumulative drug release. In this Box-Behnken design run total 17 batches with 5 center points, out of this batch B12 has good emulsification time 18±2.64sec, good % transmittance 99.08±0.23% and % cumulative drug release 99.43±0.015% within 45 min. The solid-SMEDDS prepared by using 2% w/v mannitol as cryoprotectant by lyophilization technique. This freeze dried powder has a good flow property. The in vitro dissolution study of freeze dried powder compared with plain drug and marketed tablet. The freeze dried powder shown 99.28±0.013% drug release within 45 min, while plain drug showed only 37.88±0.025 % and marketed formulation showed only 58.31±0.015 % dissolution at the end of 45 min. The in vitro dissolution studies indicate that formulation of AM in the form of freeze dried powder of SMEDDS enhances the dissolution properties.