NEW PHARMACEUTICAL COMPOSITION Russian patent published in 2022 - IPC A61K9/20 A61K31/506 A61K47/38 A61P35/00 

FIELD: pharmaceutics.

SUBSTANCE: group of inventions relates to the field of pharmaceutics, and it is intended for the production of an oral suspension of dabrafenib mesylate. A dispersible tablet contains methane sulfonate salt of N-{3-[5-(2-amino-4-pyrimidinyl)-2-(1,1-dimethylethyl)-1,3-thiazol-4-yl]-2-fluorophenyl}-2,6- difluorobenzenesulfonamide, Hypromellose, mannitol, microcrystal cellulose, at least one pharmaceutically acceptable forming agent suitable for the preparation of tablets. Components are used in the claimed amounts. The tablet is characterized by disintegration measured according to a disintegration test in European Pharmacopoeia 2.9.1, wherein time of complete decay of the tablet in water at a temperature from 15°C to 25°C is 3 minutes and less. In another embodiment, a method for the production of the specified dispersible tablet is presented. A dispersible tablet is also provided, containing an inner phase and an outer phase, where (a) the inner phase includes methane sulfonate salt of N-{3-[5-(2-amino-4-pyrimidinyl)-2-(1,1-dimethylethyl)-1,3-thiazol-4-yl]-2-fluorophenyl}-2,6- difluorobenzenesulfonamide, microcrystal cellulose, mannitol, Hypromellose, acesulfame potassium, crospovidone, colloidal silicon dioxide, magnesium stearate, and (b) the outer phase includes: microcrystal cellulose, mannitol, Hypromellose, crospovidone, magnesium stearate.

EFFECT: use of a group of inventions allows for the production of a stable dispersible tablet of dabrafenib mesylate, which has short time of disintegration for convenient reduction of a suspension and low fragility.

16 cl, 4 tbl, 3 ex