FIELD: medicine.
SUBSTANCE: group of inventions relates to medicine, in particular to a pharmaceutical composition containing a pyridine compound of formula (I), a method for preparing and using it. Disclosed pharmaceutical composition contains a compound of formula (I) or a pharmaceutically acceptable salt thereof, filler, lubricant and baking powder, where water content in filler is not more than 1.5 wt.%
wherein the filler is selected from one or from a mixture of microcrystalline cellulose and anhydrous calcium hydrophosphate, the baking powder is selected from one or a mixture of crospovidone and croscarmellose sodium, the lubricant is selected from one or a mixture of silicon dioxide and hydrogenated castor oil. Disclosed is an embodiment of the composition, which contains a compound of formula (I) or a pharmaceutically acceptable salt thereof, microcrystalline cellulose, anhydrous calcium phosphate, croscarmellose sodium, silicon dioxide and hydrogenated castor oil, in which content of water in microcrystalline cellulose and anhydrous calcium hydrophosphate is not more than 1.5 wt.%. Method for preparing the above pharmaceutical composition involves: a) grinding a compound of formula (I) or a pharmaceutically acceptable salt thereof; b) mixing a compound of formula (I) or a pharmaceutically acceptable salt thereof, obtained at step (a), with a filler, a disintegrant and part of a lubricant and sieving the mixture and c) mixing the mixture with the remaining lubricant. Also disclosed is use of said composition in preparing a drug for preventing or treating non-small cell lung cancer, particularly ROS1-positive non-small cell lung cancer.
EFFECT: pharmaceutical composition has good stability and fluidity and is suitable for industrial production of a medicinal agent for clinical use.
15 cl, 2 dwg, 2 tbl, 4 ex
Authors
Dates
2024-09-25—Published
2020-05-22—Filed