Super-heated aqueous particle engineering (SHAPE): a novel method for the micronization of poorly water soluble drugs

Super-heated aqueous particle engineering (SHAPE) is a novel particle engineering technology that utilizes the elevated boiling point of pressurized water in order to melt and emulsify hydrophobic drug particles, and then use the newly formed droplets as templates for engineering new particles with different physicochemical properties. When the temperature of an aqueous phase is elevated above the melting point of a drug, the drug quickly melts and forms a low viscosity, immiscible liquid, which is then broken up into nano or micro sized droplets under continuous stirring. The interfacial tension between the droplets and liquid serves to shape them into uniform spherical particles. These droplets can hold their shape as the dispersion is cooled back down below the melting point of the drug. During this cooling stage, either solid crystalline or amorphous microparticles can be formed depending on the cooling rate that is selected. The particles are then collected and can be utilized in many different pharmaceutical applications. In this manuscript, we use this particle engineering technique, employing the model drug carvedilol (CARV), to investigate the effect that different stabilizers/surfactants exert on the particle size and morphology. © 2017, The Korean Society of Pharmaceutical Sciences and Technology.