2(3) Full factorial design for optimization of stable amorphous host-guest-based mirabegron complex for extended-release action

The current study was to develop a stable amorphous mirabegron complex with improved solubility, stability, and extended-release of action. HP beta CD was screened as a suitable complexing agent, which exhibited an entrapment efficiency of 91.2 +/- 3.4% and facilitated transformation of drug into the amorphous state. The addition of ethylcellulose extended the release of the complex by 81.4 +/- 2.8% for 12 h. The influence of HP beta CD and ethyl cellulose on the crystal habit of mirabegron was analyzed by XRPD, DSC, ATR FTIR and morphological behavior were analyzed by SEM. 2(3) Full factorial design was used to optimize the mirabegron complex. The outcomes of stability studies illustrated amorphous complex was stable for 6 months at long-term and accelerated storage conditions, where content uniformity came under the accepted range of 98-102%. Thus, HP beta CD-based inclusion complex represents a futuristic approach to design mirabegron formulation with improved solubility and extended-release of action in over active bladder syndrome. Graphic abstract Host-guest complex of HP beta CD and mirabegron.