Methods for fine particle manufacture

Abstract

Processes for preparing micronized particles comprising a poorly water soluble bioactive agent are provided. The processes utilize a superheated aqueous phase which can serve as the continuous phase of an emulsion. The superheated aqueous phase can be used to melt poorly water soluble bioactive agents and/or matrix materials which them form molten droplets dispersed within the superheated aqueous phase. The size and size distribution of the molten droplets can be controlled using a variety of suitable methods. The molten droplets can then be cooled to form micronized particles comprising the poorly water soluble bioactive agent. If desired, the cooling rate can be selected to control the crystalline morphology of the resulting micronized particles.