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 unit dosage form for ingestion to the stomach, the unit dosage form comprising:
(i) a compound:
or a pharmaceutically acceptable salt or hydrate thereof;
(ii) a microcrystalline cellulose, wherein the weight ratio of the compound to the microcrystalline cellulose is about 1:1.5 to about 1:9; and
(iii) about 0.5% to about 5% w/w of sodium stearyl fumarate.
71 . The unit dosage form of claim 70 , wherein the weight ratio of the compound to the microcrystalline cellulose is about 1:1.5 to about 1:2.
72 . The unit dosage form of claim 70 , wherein the microcrystalline cellulose is silicified microcrystalline cellulose.
73 . The unit dosage form of claim 70 , wherein the unit dosage form comprises about 0.5% to about 2% w/w of sodium stearyl fumarate.
74 . The unit dosage form of claim 73 , wherein the unit dosage form comprises about 1% w/w of sodium stearyl fumarate.
75 . The unit dosage form of claim 70 , wherein the compound is in the form of a dihydrochloride monohydrate:
and
the weight ratio of
to the microcrystalline cellulose is about 1:1.5 to about 1:9.
76 . The unit dosage form of claim 71 , wherein the compound is in the form of a dihydrochloride monohydrate:
and
the weight ratio of
to the microcrystalline cellulose is about 1:1.5 to about 1:2.
77 . The unit dosage form of claim 72 , wherein the compound is in the form of a dihydrochloride monohydrate:
and
the weight ratio of
to the microcrystalline cellulose is about 1:1.5 to about 1:9.
78 . The unit dosage form of claim 73 , wherein the compound is in the form of a dihydrochloride monohydrate:
and
the weight ratio of
to the microcrystalline cellulose is about 1:1.5 to about 1:9.
79 . The unit dosage form of claim 74 , wherein the compound is in the form of a dihydrochloride monohydrate:
and
the weight ratio of
to the microcrystalline cellulose is about 1:1.5 to about 1:9.
80 . A unit dosage form for ingestion to the stomach, the unit dosage form comprising:
(i) a compound:
or a pharmaceutically acceptable salt or hydrate thereof;
(ii) a microcrystalline cellulose, wherein the weight ratio of the compound to the microcrystalline cellulose is 1:1.5 to 1:9; and
(iii) one or more lubricants.
81 . The unit dosage form of claim 80 , wherein the one or more lubricants comprises sodium stearyl fumarate.
82 . The unit dosage form of claim 80 , wherein the weight ratio of the compound to the microcrystalline cellulose is 1:1.5 to 1:2.
83 . The unit dosage form of claim 80 , wherein the microcrystalline cellulose is silicified microcrystalline cellulose.
84 . The unit dosage form of claim 80 , wherein the unit dosage form comprises about 0.5% to about 5% w/w of the one or more lubricants.
85 . The unit dosage form of claim 84 , wherein the unit dosage form comprises about 0.5% to about 2% w/w of the one or more lubricants.
86 . The unit dosage form of claim 85 , wherein the unit dosage form comprises about 1% w/w of the one or more lubricants.
87 . The unit dosage form of claim 80 , wherein the compound is in the form of a dihydrochloride monohydrate:
and
the weight ratio of
to the microcrystalline cellulose is about 1:1.5 to about 1:9.
88 . The unit dosage form of claim 81 , wherein the compound is in the form of a dihydrochloride monohydrate:
and
the weight ratio of
to the microcrystalline cellulose is about 1:1.5 to about 1:9.
89 . The unit dosage form of claim 82 , wherein the compound is in the form of a dihydrochloride monohydrate:
and
the weight ratio of
to the microcrystalline cellulose is about 1:1.5 to about 1:2.
90 . The unit dosage form of claim 83 , wherein the compound is in the form of a dihydrochloride monohydrate:
and
the weight ratio of
to the microcrystalline cellulose is about 1:1.5 to about 1:9.
91 . The unit dosage form of claim 84 , wherein the compound is in the form of a dihydrochloride monohydrate:
and
the weight ratio of
to the microcrystalline cellulose is about 1:1.5 to about 1:9.
92 . The unit dosage form of claim 85 , wherein the compound is in the form of a dihydrochloride monohydrate:
and
the weight ratio of
to the microcrystalline cellulose is about 1:1.5 to about 1:9.
93 . The unit dosage form of claim 86 , wherein the compound is in the form of a dihydrochloride monohydrate:
and
the weight ratio of
to the microcrystalline cellulose is about 1:1.5 to about 1:9.
94 . A unit dosage form for ingestion to the stomach, the unit dosage form comprising:
(i) a compound:
or a pharmaceutically acceptable salt or hydrate thereof;
(ii) one or more fillers and/or diluents; and
(iii) about 0.5% to about 5% w/w of sodium stearyl fumarate.
95 . The unit dosage form of claim 94 , wherein the one or more fillers and/or diluents comprises a microcrystalline cellulose.
96 . The unit dosage form of claim 95 , wherein the microcrystalline cellulose is silicified microcrystalline cellulose.
97 . The unit dosage form of claim 94 , wherein the compound is in the form of a dihydrochloride monohydrate:
98 . The unit dosage form of claim 95 , wherein the compound is in the form of a dihydrochloride monohydrate:
99 . The unit dosage form of claim 96 , wherein the compound is in the form of a dihydrochloride monohydrate:
100 . A unit dosage form for ingestion to the stomach, the unit dosage form comprising:
(i) a compound:
or a pharmaceutically acceptable salt 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) about 0.5% to about 5% w/w of a lubricant.
101 . The unit dosage form of claim 100 , wherein the compound is in the form of a dihydrochloride monohydrate:
and
the ratio of the weight of
to the total weight of the one or more fillers and/or diluents is about 1:1.5 to about 1:9.
102 . The unit dosage form of claim 100 , 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.
103 . The unit dosage form of claim 100 , wherein the unit dosage form comprises about 0.5% to about 2% w/w of the lubricant.
104 . The unit dosage form of claim 103 , wherein the unit dosage form comprises about 1% w/w of the lubricant.