Abstract

PHYSICOCHEMICAL CHARACTERIZATION AND IN VITRO DISSOLUTION ENHANCEMENT OF MIRABEGRON USING SOLID DISPERSION METHOD

Digvisha A. Patel* and Dr. Dhaval J. Patel

ABSTRACT

The solid dispersions of Mirabegron with PEG, Gelucire 43/01, and Poloxamer 407 & PVP have been prepared in different weight ratios by using methods like solvent evaporation. Phase solubility studies showed a significant solubilizing effect of all polymers on Mirabegron at different temperatures. FTIR, DSC, and X-ray diffraction spectroscopy were used to characterize the samples of solid dispersions and physical mixture. X-ray powder diffraction and thermal analysis indicated that the drug was present in amorphous form at high concentration of both polymers. In this system, trapping of drug inside polymeric matrix was demonstrated using FTIR. The highest improvements in solubility and in-vitro drug release were observed in solid dispersion prepared with Poloxamer 407 by solvent evaporation method. The increased dissolution rate of drug from solid dispersion may be due to surface tension lowering effect of polymer to the medium and increased wettability and dispersibility of Mirabegron. Dissolution Efficiency is calculated form DD solver Software and found maximum in S12 batch. Further the prepared tablets using S12 solid dispersion gives maximum dissolution as compared to pure Mirabegron. Additionally S12 give more and fast drug release than the marketed preparation Myrbetriq. These findings are extremely important from a commercial point of view as the prepared solid dispersion removes drawback of poor dissolution of Mirabegron.

Keywords: Mirabegron, Dissolution, Solid Dispersion, Phase Solubility.