Novel crystalline salt form of 2,2-dimethyl-6-((4-((3,4,5-trimethoxyphenyl)amino)-1,3,5-triazin-2-yl)amino)-2H-pyrido[3,2-B][1,4]oxazin-3(4H)-one for medical application

The invention relates to the chemistry of organic compounds, to pharmacology and to medicine, and pertains to the prevention and treatment of human and animal diseases associated with metabolic disorders of bone tissues and/or cartilage tissues, particularly diseases of the musculoskeletal system, such as osteoarthritis or osteoporosis, using a novel salt form of 2,2-dimethyl-6-((4-((3,4,5-trimethoxyphenyl)amino)-1,3,5-triazin-2-yl)amino)-2H-pyrido[3,2-B][1,4]oxazin-3(4H)-one. A salt of the present compound with 4-methylbenzenesulfonic acid, (I) including the hydrates and solvates thereof, and polymorphic modifications of the salt, hydrates and solvates, is characterized by increased effectiveness of inhibiting Src-family kinases, Syk kinase and also other therapeutically-significant kinases, and by acceptable pharmacokinetic parameters. The present invention also relates to pharmaceutical compositions containing a therapeutically-effective amount of the salt according to the invention.