IP Library › Patent Application 18745080
Patent Application
App. No. 18/745,080

TABLET COMPOSITIONS

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Patent No.
US None
App. No.
18/745,080
Abstract

Provided herein is a tablet comprising 2-methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol or a pharmaceutically acceptable salt thereof.

Claims (9)

1 - 34 . (canceled)

35 . A method of treating a proliferative disease comprising administering to a subject in need thereof a tablet comprising 25% 2-methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol methanesulfonate; intra-granular excipients comprising 39.50% microcrystalline cellulose, 2% hydroxypropyl cellulose, 6% sodium starch glycolate, 1% sodium lauryl sulfate, 1% hypromellose acetate succinate, 1.5% colloidal silicon dioxide, and 0.75% magnesium stearate; and extra-granular excipients comprising 20% microcrystalline cellulose, 2% sodium starch glycolate, 0.5% colloidal silicon dioxide, and 0.75% magnesium stearate, all based on total weight of the tablet, wherein the tablet is coated with a film coating.

36 . The method of claim 35 , wherein the tablet comprises about 25, 50, 100, 150, or 200 mg strength of 2-methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol.

37 . The method of claim 35 , wherein the tablet comprises ≤10% amorphous 2-methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol methanesulfonate, 2-methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol or a mixture thereof.

38 . The method of claim 35 , wherein the tablet is a coated with polyvinyl alcohol.

39 . The method of claim 35 , wherein the proliferative disease is cancer.

40 . The method of claim 35 , wherein the proliferative disease is selected from glioma, melanoma, chondrosarcoma, acute myelogenous leukemia, myelodysplastic syndrome, chronic myelomonocytic leukemia, lymphoma and myeloproliferative neoplasm, each characterized by the presence of a mutant allele of IDH2.

41 . The method of claim 35 , wherein the proliferative disease is acute myelogenous leukemia characterized by the presence of a mutant allele of IDH2.

42 . The method of claim 35 , wherein the proliferative disease is relapsed or refractory acute myelogenous leukemia characterized by the presence of a mutant allele of IDH2.