Patent ID: 8257739

Claim:
A composition comprising: (a) a solid comprising a low-solubility drug and a concentration-enhancing polymer; (b) said concentration-enhancing polymer being present in said composition in a sufficient amount so that said composition provides enhanced concentration of said drug in a use environment relative to a first control composition consisting essentially of a mixture of an equivalent amount of said drug in crystalline form and an equivalent amount of said concentration-enhancing polymer; said composition made by forming a solid amorphous dispersion of said low solubility drug and said concentration-enhancing polymer followed by treating said dispersion by a method selected from the group consisting of (1) heating said dispersion to a temperature T in degrees Kelvin wherein said dispersion has a glass-transition temperature T g in degrees Kelvin, and wherein said heating satisfies the relationship T g /T≦1; (2) exposing said dispersion to a mobility enhancing agent; and (3) a combination of (1) and (2); wherein: at least a portion of said drug is present in drug-rich regions and said drug-rich regions are interspersed throughout drug-poor, polymer-rich regions, at least 60 wt % of said drug is in a non-amorphous semi-ordered state selected from the group consisting of small crystals of said drug having a size of less than 200 nm in at least one dimension, crystalline drug having said concentration-enhancing polymer incorporated into said crystals, crystals containing crystal defects, and semicrystalline structure, and said drug in said non-amorphous semi-ordered state exhibits at least one of: (i) a powder x-ray diffraction pattern that is different from a powder x-ray diffraction pattern of said first control composition, wherein at least one peak present in said diffraction pattern of said first control composition is not present in said diffraction pattern of said drug in said composition; (ii) a powder x-ray diffraction pattern having at least one peak that has a full width at half height of at least 1.1-fold that of an equivalent peak exhibited by said drug in said first control composition; (iii) an onset in the melt endotherm that is at a lower temperature than the onset in the melt endotherm of said drug in said first control composition; or (iv) a maximum in the melt endotherm that is at a lower temperature than the maximum in the melt endotherm of said drug in said first control composition and wherein said composition comprising said polymer and said drug in said non-amorphous semi-ordered state exhibits a glass transition temperature that is different than the glass transition temperature of a second control composition, said second control composition consisting essentially of a solid amorphous dispersion of an equivalent amount of said drug and an equivalent amount of said concentration enhancing polymer wherein said drug in said second control composition is at least 90 wt % amorphous.