COMPOSITIONS AND METHODS FOR TREATING MYELOFIBROSIS
Provided herein are compositions and methods for treating myelofibrosis in a subject. The methods comprise administering to the subject an effective amount of compound which is which is N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino]benzenesulfonamide or a pharmaceutical salt thereof or a hydrate thereof.
1 - 69 . (canceled)
70 . A method of treating a myeloproliferative disorder comprising administering to a subject in need thereof a unit dosage form comprising an admixture of:
(i) a compound:
or a pharmaceutically acceptable salt and/or hydrate thereof;
(ii) one or more fillers and/or diluents, wherein the ratio of the weight of the compound to the total weight of the one or more fillers and/or diluents is about 1:1.5 to about 1:9; and
(iii) one or more lubricants that is about 0.5% to about 5% w/w of the total weight of the admixture;
wherein the unit dosage form provides, when administered once daily at a 400 mg total daily dose of the compound,
a C max that is achieved within 2 to 4 hours post administration; and/or
a C max between 1717.33 ng/ml and 3886.67 ng/mL.
71 . The method of claim 70 , wherein the compound is in the form of a dihydrochloride monohydrate:
72 . The method of claim 70 , wherein the ratio of the weight of the compound to the total weight of the one or more fillers and/or diluents is about 1:1.5 to about 1:2.
73 . The method of claim 70 , wherein the one or more fillers and/or diluents comprises a microcrystalline cellulose.
74 . The method of claim 73 , wherein the microcrystalline cellulose is silicified microcrystalline cellulose.
75 . The method of claim 71 , wherein the one or more fillers and/or diluents comprises a microcrystalline cellulose.
76 . The method of claim 75 , wherein the microcrystalline cellulose is silicified microcrystalline cellulose.
77 . The method of claim 70 , wherein the one or more lubricants is about 0.5% to about 2% w/w of the total weight of the admixture.
78 . The method of claim 77 , wherein the one or more lubricants is about 1% w/w of the total weight of the admixture.
79 . The method of claim 70 , wherein the one or more lubricants comprises sodium stearyl fumarate.
80 . The method of claim 71 , wherein the one or more lubricants is about 0.5% to about 2% w/w of the total weight of the admixture.
81 . The method of claim 80 , wherein the one or more lubricants is about 1% w/w of the total weight of the admixture.
82 . The method of claim 71 , wherein the one or more lubricants comprises sodium stearyl fumarate.
83 . The method of claim 73 , wherein the one or more lubricants is about 0.5% to about 2% w/w of the total weight of the admixture.
84 . The method of claim 83 , wherein the one or more lubricants is about 1% w/w of the total weight of the admixture.
85 . The method of claim 73 , wherein the one or more lubricants comprises sodium stearyl fumarate.
86 . The method of claim 75 , wherein the one or more lubricants is about 0.5% to about 2% w/w of the total weight of the admixture.
87 . The method of claim 86 , wherein the one or more lubricants is about 1% w/w of the total weight of the admixture.
88 . The method of claim 75 , wherein the one or more lubricants comprises sodium stearyl fumarate.
89 . The method of claim 70 , wherein the unit dosage form provides a C max of the compound that is achieved within 2 to 4 hours post administration.
90 . The method of claim 70 , wherein the unit dosage form provides a C max between 1717.33 ng/mL and 3886.67 ng/mL.
91 . The method of claim 70 , wherein the myeloproliferative disorder is myelofibrosis.
92 . The method of claim 91 , wherein the myelofibrosis is primary myelofibrosis.
93 . The method of claim 91 , wherein the myelofibrosis is intermediate risk level 2 myelofibrosis.
94 . The method of claim 91 , wherein the myelofibrosis is high risk myelofibrosis.
95 . The method of claim 91 , wherein the myelofibrosis is secondary myelofibrosis.
96 . The method of claim 91 , wherein the myelofibrosis is post essential thrombocythemia myelofibrosis.
97 . The method of claim 91 , wherein the myelofibrosis is post polycythemia vera myelofibrosis.