US2018028538A1PendingUtilityA1

Novel composition for treatment of essential thrombocythemia

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Assignee: AOP ORPHAN PHARMACEUTICALS AGPriority: Mar 25, 2010Filed: Oct 4, 2017Published: Feb 1, 2018
Est. expiryMar 25, 2030(~3.7 yrs left)· nominal 20-yr term from priority
Inventors:Rudolf WidmannGeorg Strieder
A61P 7/00A61P 35/02A61P 7/02A61K 31/517A61K 9/16A61K 9/2054A61K 9/2013A61K 9/2027A61K 47/38A61K 47/12A61K 31/519A61K 9/20A61K 47/32
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Claims

Abstract

The present invention relates to a novel pharmaceutical composition free of gastric coating comprising anagrelide hydrochloride in combination with a non-pH dependent polymer and a pharmaceutically acceptable water soluble acid and its use for the treatment of essential thrombocythemia.

Claims

exact text as granted — not AI-modified
1 . A pharmaceutical composition free of gastric coating comprising anagrelide HCl, a non-pH dependent polymer and a pharmaceutically acceptable water soluble acid, wherein the non-pH dependent polymer is selected from the group consisting of a cellulose derivative and a polyacrylamide, and wherein the amount of the non-pH dependent polymer is between 1.5 and 2.5 fold of the anagrelide (w/w). 
     
     
         2 . The pharmaceutical composition according to  claim 1 , wherein the anagrelide HCl is in the form of particles, and wherein at least 90% of said particles are smaller than 10 μm in diameter. 
     
     
         3 . The pharmaceutical composition according to  claim 1 , wherein the anagrelide HCl is present in an amount of between 0.5 mg and 5 mg. 
     
     
         4 . The pharmaceutical composition according to  claim 1 , wherein the pharmaceutically acceptable water soluble acid is selected from the group consisting of adipic acid, ascorbic acid, citric acid, fumaric acid, malic acid, succinic acid, tartaric acid and a mixture thereof. 
     
     
         5 . The pharmaceutical composition according to  claim 1 , wherein the water soluble acid is present in an amount of between 5 mg and 40 mg. 
     
     
         6 . The pharmaceutical composition according to  claim 1 , wherein the anagrelide HCl has a mean particle size of about 5 μm. 
     
     
         7 . The pharmaceutical composition according to  claim 1 , further comprising microcrystalline cellulose. 
     
     
         8 . The pharmaceutical composition according to  claim 7 , wherein the microcrystalline cellulose is present in an amount of between 10 mg and 150 mg. 
     
     
         9 . The pharmaceutical composition according to  claim 1 , wherein the pharmaceutical composition is in the form of a tablet. 
     
     
         10 . The pharmaceutical composition according to  claim 3 , wherein the composition comprises anagrelide HCl in an amount of between 2 mg and 3 mg. 
     
     
         11 . The pharmaceutical composition according to  claim 7 , wherein the water soluble acid is present in an amount of between 15 mg and 19 mg. 
     
     
         12 . The pharmaceutical composition according to  claim 10 , wherein the microcrystalline cellulose is present in an amount of between 70 mg and 80 mg. 
     
     
         13 . A method of treating essential thrombocythemia, comprising administering to a patient in need thereof the pharmaceutical composition of  claim 1 .

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