Improved water-insoluble drug particle process

摘要

A process for the preparation of small particles containing a poorly water soluble drug, whereby in an aqueous carrier in the absence of an organic solvent an admixture of a poorly water soluble drug and a surface active substance are mixed at high shear within a first temperature range at or above said drugs' melting point to form a heated suspension, the suspension is then homogenized in a first pressure range and within said first temperature range to form a heated homogenate, and then cooled to a second temperature range below the drugs' melting point to form a transiently stable cooled homogenate, then a particle stabilizing energy is applied to the cooled homogenate within the second temperature range and in a second pressure range to form a cooled dispersion of stabilized small particles.