CRYSTAL CHEMOTHERAPEUTIC BASES ON THE BASIS OF INDAZOLE

摘要

1. Crystalline form 1 of the hydrate N- [4- (3-amino-1H-indazol-4-yl) phenyl] -N '- (2-fluoro-5-methylphenyl) urea, which when measured at approximately 25 ° C a long wavelength of x-ray radiation equal to 1.54178 Å, characterized by a powder x-ray having a relative 2Θ magnitude, approximately equal to 6.2 °, 12.0 °, 12.4 °, 12.8 °, 13.4 °, 14.2 °, 15.2 °, 15.6 °, 16.2 ° and 19.7 °. ! 2. A composition containing an excipient and crystalline form 1 of a hydrate of N- [4- (3-amino-1H-indazol-4-yl) phenyl] -N '- (2-fluoro-5-methylphenyl) urea, which, when measured at approximately 25 ° C with a x-ray wavelength of 1.54178 Å, characterized by a powder x-ray having a relative 2 име value, approximately equal to 6.2 °, 12.0 °, 12.4 °, 12.8 °, 13.4 °, 14.2 °, 15.2 °, 15.6 °, 16.2 ° and 19.7 °. ! 3. A method of treating cancer in mammals, comprising administering for this purpose in the presence or absence of one or more anti-cancer drugs a therapeutically effective amount of crystalline form 1 of N- [4- (3-amino-1H-indazol-4-yl) hydrate phenyl] -N '- (2-fluoro-5-methylphenyl) urea, which when measured at approximately 25 ° C with an X-ray wavelength of 1.54178 Å, is characterized by a powder x-ray having a relative 2Θ magnitude of approximately 6, 2 °, 12.0 °, 12.4 °, 12.8 °, 13.4 °, 14.2 °, 15.2 °, 15.6 °, 16.2 ° and 19.7 °. ! 4. The method of obtaining crystalline form 1 of the hydrate of N- [4- (3-amino-1H-indazol-4-yl) phenyl] -N '- (2-fluoro-5-methylphenyl) urea, including:! obtaining a mixture containing N- [4- (3-amino-1H-indazol-4-yl) phenyl] -N '- (2-fluoro-5-methylphenyl) urea and a solvent, where N- [4- (3- amino-1H-indazol-4-yl) phenyl] -N '- (2-fluoro-5-methylphenyl) urea is completely soluble in this solvent; and! challenge