Details for Patent: 8,829,015
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Title: | Crystalline forms of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyr- idin-3-yl-pyrimidin-2-ylamino)-benzamide |
Abstract: | Crystalline forms of 4-methyl-N-3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl-3-(4-pyrid- in-3-yl-pyrimidin-2-ylamino)-benzamide free base and salts thereof are prepared by various processes. |
Inventor(s): | Manley; Paul W. (Arlesheim, CH), Shieh; Wen-Chung (Berkeley Heights, NJ), Sutton; Paul Allen (Parsippany, NJ), Karpinski; Piotr "Peter" H. (Lincoln Park, NJ), Wu; Raeann (Pine Brook, NJ), Monnier; Stephanie (Raedersheim, FR), Brozio; Jorg (Basel, CH) |
Assignee: | Novartis AG (Basel, CH) |
Filing Date: | Feb 22, 2013 |
Application Number: | 13/774,433 |
Claims: | 1. A method of treating Philadelphia chromosome positive chronic myelogenous leukemia comprising the step of administering to a subject in need thereof, a therapeutically effective amount of crystalline form B of the hydrochloride salt of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyr- idin-3-yl-pyrimidin-2-ylamino)-benzamide as a monohydrate, characterized by an x-ray powder diffraction pattern having at least one maxima selected from about 7.2.degree., 9.2.degree., 11.4.degree., 12.0.degree., 12.3.degree., 14.6.degree., 14.8.degree., 15.7.degree., 17.6.degree., 19.2.degree., 19.5,.degree. 20.5.degree., 22.0.degree., 23.4.degree., 23.9.degree., 25.0.degree., 25.5.degree., 25.9.degree., 27.0.degree. (2.theta. degrees). 2. A method of treating Philadelphia chromosome positive chronic myelogenous leukemia comprising the step of administering to a subject in need thereof, a therapeutically effective amount of crystalline form B of the hydrochloride salt of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyr- idin-3-yl-pyrimidin-2-ylamino)-benzamide as a monohydrate, characterized by an x-ray powder diffraction pattern having at least one maxima selected from about 7.2.degree., 9.2.degree., 11.4.degree., 12.0.degree., 12.3.degree., 14.6.degree., 14.8.degree., 15.7.degree., 17.6.degree., 19.2.degree., 19.5,.degree. 20.5.degree., 22.0.degree., 23.4.degree., 23.9.degree., 25.0.degree., 25.5.degree., 25.9.degree., 27.0.degree. (2.theta. degrees) and at least one pharmaceutically acceptable carrier, diluent or excipient. |