STABILIZED HME COMPOSITION WITH SMALL DRUG PARTICLES

摘要

A hot-melt extruded composition having finely divided drug-containing particles dispersed within a carrier is provided. The carrier melts during extrusion but does not dissolve the drug. As a result a majority of the particles are nopaggregated during extrusion into crystalline or amorphous particles. Various excipients can be included in the carrier system to stabilize the particle size. A hydrophilic polymer can also be Included in the composition. A process for preparing the extrudate Is conducted at a temperature at or above the melting point of the matrix and below the point of solubilization of the drug-containing particles and below the rßcrystallization point of the amorphous fine-drug particles.