US2021244735A1PendingUtilityA1

Compositions and methods for treating myelofibrosis

64
Assignee: IMPACT BIOMEDICINES INCPriority: Nov 7, 2010Filed: Apr 1, 2021Published: Aug 12, 2021
Est. expiryNov 7, 2030(~4.3 yrs left)· nominal 20-yr term from priority
Inventors:Arvind JayanJanice Louise Cacace
A61K 31/506A61K 9/4866A61K 2121/00A61K 9/0053A61P 35/00A61K 9/48A61K 9/4858A61P 7/00A61P 19/08
64
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Claims

Abstract

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.

Claims

exact text as granted — not AI-modified
1 - 69 . (canceled) 
     
     
         70 . A pharmaceutical formulation comprising a compound that is N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino]benzenesulfonamide or a pharmaceutically acceptable salt and/or hydrate thereof, characterized in that the formulation provides:
 a steady state patient C max  of the compound that is achieved within 2 to 4 hours post administration; and/or   a steady state patient C max  of the compound between 1717.33 ng/mL and 3886.67 ng/mL post administration.   
     
     
         71 . The formulation of  claim 70 , characterized in that the formulation provides a C max  of the compound that is achieved within 2 to 4 hours post administration. 
     
     
         72 . The formulation of  claim 70 , characterized in that the formulation provides a C max  of the compound between 1717.33 ng/mL and 3886.67 ng/mL post administration. 
     
     
         73 . The formulation of  claim 70 , wherein the formulation further comprises a filler. 
     
     
         74 . The formulation of  claim 73 , wherein the filler is a microcrystalline cellulose. 
     
     
         75 . The formulation of  claim 70 , wherein the formulation further comprises a lubricant. 
     
     
         76 . The formulation of  claim 73 , wherein the formulation further comprises a lubricant. 
     
     
         77 . The formulation of  claim 74 , wherein the formulation further comprises a lubricant. 
     
     
         78 . The formulation of  claim 75 , wherein the lubricant is sodium stearyl fumarate. 
     
     
         79 . The formulation of  claim 76 , wherein the lubricant is sodium stearyl fumarate. 
     
     
         80 . The formulation of  claim 77 , wherein the lubricant is sodium stearyl fumarate. 
     
     
         81 . The formulation of  claim 70 , wherein the formulation comprises about 400 mg of the compound. 
     
     
         82 . The formulation of  claim 73 , wherein the formulation comprises about 400 mg of the compound. 
     
     
         83 . The formulation of  claim 74  wherein the formulation comprises about 400 mg of the compound. 
     
     
         84 . The formulation of  claim 75 , wherein the formulation comprises about 400 mg of the compound. 
     
     
         85 . The formulation of  claim 76 , wherein the formulation comprises about 400 mg of the compound. 
     
     
         86 . The formulation of  claim 77 , wherein the formulation comprises about 400 mg of the compound. 
     
     
         87 . The formulation of  claim 78 , wherein the formulation comprises about 400 mg of the compound. 
     
     
         88 . The formulation of  claim 79 , wherein the formulation comprises about 400 mg of the compound. 
     
     
         89 . The formulation of  claim 80 , wherein the formulation comprises about 400 mg of the compound. 
     
     
         90 . The formulation of  claim 70 , wherein the compound is N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino]benzenesulfonamide dihydrochloride monohydrate. 
     
     
         91 . The formulation of  claim 73 , wherein the compound is N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino]benzenesulfonamide dihydrochloride monohydrate. 
     
     
         93 . The formulation of  claim 74 , wherein the compound is N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino]bezenesulfonamide dihydrochloride monohydrate. 
     
     
         94 . The formulation of  claim 75 , wherein the compound is N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino]bezenesulfonamide dihydrochloride monohydrate. 
     
     
         95 . The formulation of  claim 76 , wherein the compound is N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino]bezenesulfonamide dihydrochloride monohydrate. 
     
     
         96 . The formulation of  claim 77 , wherein the compound is N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino]bezenesulfonamide dihydrochloride monohydrate. 
     
     
         97 . The formulation of  claim 78 , wherein the compound is N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino]bezenesulfonamide dihydrochloride monohydrate. 
     
     
         98 . The formulation of  claim 79 , wherein the compound is N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino]benzenesulfonami de dihydrochloride monohydrate. 
     
     
         99 . The formulation of  claim 80 , wherein the compound is N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino]bezenesulfonamide dihydrochloride monohydrate.

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