abstract |
Drugs that are effective but only slightly soluble, such as 5-chloro-1H-indole-2-carboxylic acid [(1S) -benzyl- (2R) -hydroxy-3-((3R, 4S)- Pharmaceutical compositions of dihydroxy-pyrrolidin-1-yl-)-3-oxypropyl] amide, and methods for making such compositions and providing dosage forms from such compositions. The following steps: (a) forming particles of a solid amorphous dispersion, each comprising a soluble drug and a concentration enhancing polymer; (b) particles and matrix material of said solid amorphous dispersion. Blending and forming a blend; c) sending the blend to a melt-solidification step to form a melt mixture comprising particles of the solid amorphous dispersion and the matrix material; and (d) the melt mixture. Cooling said solid amorphous dispersion particles to form solid particles comprising said matrix material. [Selection figure] None |