A hot-melt extruded composition having finely divided
drug-containing particles dispersed within a polymeric and / or lipophyllic carrier matrix is provided. The carrier softens or melts during hot-
melt extrusion but it does not dissolve the
drug-containing particles during
extrusion. As a result, a majority or at least 90% wt. of the
drug-containing particles in the extrudate are deaggregated during
extrusion into essentially primary crystalline and / or amorphous particles. PEO is a suitable
carrier material for drugs insoluble in the
solid state in this carrier. Various functional excipients can be included in the
carrier system to stabilize the particle size and physical state of the drug substance in either a crystalline and / or amorphous state. The
carrier system is comprised of at least one thermal binder, and may also contain various functional excipients, such as: super-disintegrants, antioxidants, surfactants,
wetting agents,
stabilizing agents, retardants, or similar functional excipients. A hydrophilic
polymer, such as hydroxypropyl methylcellulose (HPMC E15),
polyvinyl alcohol (PVA), or
poloxamer, and / or a surfactant, such as
sodium lauryl
sulfate (SLS), can be included in the composition. A process for preparing the extrudate is conducted at a temperature approximating or above the
softening or
melting temperature of the matrix and below the point of solubilization of drug-containing particles in the
carrier system, and below the recrystallization point in the case of amorphous fine drug particles.