Box Behnken Design for Optimization of Mirabegron Solid Dispersion by Fluidized Bed Processing

Abstract

The present study was to develop a stable mirabegron solid dispersion by FBP technique with improved solubility, dissolution and stability. The solid dispersion of mirabegron with poloxamer, PEG-6000 and PVP K-30 has been prepared with different weight ratios by using FBP technique. Saturation solubility studies showed significant effect of all polymers on solubility of mirabegron. MS9 batch showed maximum solubility 198.48 μg/ml in water. Box Behnken design was applied for the development of ER formulation of mirabegron by considering poloxamer, BHT and EC independent factors and drug content and drug release was dependent variables. MS9 exhibited 99.18% drug release indicated immediate release and run 6 exhibited 99.33% drug content and 99.45% at 24 h indicates significantly extend the release of mirabegron. These finding solid dispersion by fluidized bed processing is extremely important for the solubility and dissolution rate enhancement of mirabegron.