PHARMACEUTICAL DOSAGE FORM FOR ORAL ADMINISTRATION OF BCL-2 FAMILY INHIBITOR Russian patent published in 2020 - IPC A61K9/00 A61K9/14 A61K31/5377 

FIELD: medicine.

SUBSTANCE: group of inventions refers to medicine, namely to a pharmaceutical dosage form which contains a product in form of a solid dispersion, comprising a pharmaceutically active component, at least one pharmaceutically acceptable polymer containing a homopolymer or copolymer of N-vinylpyrrolidone and at least one pharmaceutically acceptable solubilisator selected from a group consisting of sorbitan esters of fatty acids, polyoxyethylene-sorbitan esters of fatty acids and combinations thereof, wherein said pharmaceutically active component is N-(4-(4-((2-(4-chlorophenyl)-5,5-dimethyl-1-cyclohex-1-en-1-yl)methyl)piperazin-1-yl)benzoyl)-4-(((1R)-3-(morpholin-4-yl)-1-((phenylsulfanyl)-methyl)propyl)amino)-3-((trifluoromethyl))sulphonyl)benzenesulphonamide, its salt, hydrate or solvate, relates to a method of treating a proliferative disorder, relates to a method of preparing a pharmaceutical dosage form.

EFFECT: group of inventions provides a dosage form which is characterized by excellent stability and particularly exhibits high resistance to recrystallisation or decomposition of the active ingredient, which is selected from N-(4-(4-((2-(4-chlorophenyl)-5,5-dimethyl-1-cyclohex-1-en-1-yl)methyl)-piperazin-1-yl)benzoyl)-4-(((1R)-3-(morpholin-4-yl)-1-((phenylsulfanyl)methyl)-propyl)amino)-3-(trifluoromethyl)sulfonyl)benzenesulphonamide.

32 cl, 8 dwg, 6 tbl, 7 ex