Patent ID: 6682761
Filing Date: 2004-01-27
Classification: A61K,A61P

Abstract:
A process for the preparation of small particles containing a poorly water soluble drug comprising:(a) mixing at high shear an admixture of a poorly water soluble drug and one or more than one surface active substance in an aqueous carrier in the absence of an organic solvent within a first temperature range at or above the melting point of the poorly water soluble drug to form a heated suspension containing the drug wherein the drug is molten; (b) homogenizing said heated suspension in a first pressure range and within said first temperature range to form a heated homogenate containing the drug wherein the drug is molten; (c) cooling said heated homogenate to a second temperature range below the melting temperature of the poorly water soluble drug to form a transiently stable cooled homogenate containing the drug; (d) applying a particle stabilizing energetic process comprising microfluidization, sonication, or milling to said cooled homogenate within a second temperature range below the melting point of the drug and in a second pressure range to form a cooled dispersion of stabilized small particles containing the drug; and (e) drying said cooled dispersion to form dried small particles containing the poorly water soluble drug.