US2021077442A1PendingUtilityA1

Continuous Administration of Dopa Decarboxylase Inhibitors and Compositions for Same

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Assignee: NEURODERM LTDPriority: May 19, 2009Filed: Apr 30, 2020Published: Mar 18, 2021
Est. expiryMay 19, 2029(~2.8 yrs left)· nominal 20-yr term from priority
A61K 31/198A61K 31/195A61K 9/20A61P 25/16C07C 279/14A61P 25/14A61K 9/08A61K 31/15A61K 31/277A61K 31/12A61K 9/0019A61P 25/28A61K 9/0053A61P 43/00C07C 243/18A61K 47/183A61K 9/0014A61K 47/22A61P 21/00A61P 25/00
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Claims

Abstract

Disclosed herein are compositions that include for example the arginine salt of carbidopa, and methods for treating neurological or movement diseases or disorders such as restless leg syndrome, Parkinson's disease, secondary parkinsonism, Huntington's disease, Parkinson's like syndrome, PSP, MSA, ALS, Shy-Drager syndrome and conditions resulting from brain injury including carbon monoxide or manganese intoxication, using substantially continuous administration of carbidopa or salt thereof together with administration of levodopa.

Claims

exact text as granted — not AI-modified
1 . A pharmaceutically acceptable liquid composition comprising carbidopa and arginine, wherein the pH of the liquid composition is about 7 to about 9 at 25° C. 
     
     
         2 . The pharmaceutically acceptable liquid composition of  claim 1 , comprising at least about 2% by weight carbidopa. 
     
     
         3 . The pharmaceutically acceptable liquid composition of  claim 3 , comprising at least about 4% by weight carbidopa. 
     
     
         4 . The pharmaceutically acceptable liquid composition of  claim 1 , wherein the liquid composition is substantially stable at 25° C. for 48 hours or more. 
     
     
         5 . The pharmaceutically acceptable liquid composition of  claim 4 , wherein the carbidopa and the arginine have a molar ratio of about 1:0.5 to about 1:2.5. 
     
     
         6 . The pharmaceutically acceptable liquid composition of  claim 5 , wherein the carbidopa and the arginine have a molar ratio of about 1:1 to about 1:1.2. 
     
     
         7 . The pharmaceutically acceptable liquid composition of  claim 5 , wherein the pH is about 8 to about 9. 
     
     
         8 . The pharmaceutically acceptable liquid composition of  claim 4 , further comprising a pharmaceutically acceptable excipient. 
     
     
         9 . The pharmaceutically acceptable liquid composition of  claim 8 , wherein the pharmaceutically acceptable excipient is selected from the group consisting of: N-methylpyrrolidone, polyvinylpyrrolidone, propylene glycol, or combinations thereof. 
     
     
         10 . The pharmaceutically acceptable liquid composition of  claim 1 , wherein the liquid composition is a liquid solution further comprising water. 
     
     
         11 . The pharmaceutically acceptable liquid composition of  claim 1 , further comprising entacapone or tolcapone. 
     
     
         12 . The arginine salt of carbidopa. 
     
     
         13 . A liquid composition comprising the arginine salt of  claim 12 . 
     
     
         14 . A method of treating Parkinson's disease, comprising:
 orally administering, to a patient in need thereof, a levodopa composition comprising a therapeutically effective amount of levopoda or a pharmaceutically acceptable salt thereof, and   administering substantially continuously to the patient the pharmaceutically acceptable liquid composition of  claim 1 .   
     
     
         15 . The method of  claim 14 , wherein continuously administering comprises transdermal or subcutaneous administration. 
     
     
         16 . The method of  claim 15 , wherein continuously administering comprises the use of an infusion pump. 
     
     
         17 . The method of  claim 14 , wherein the levodopa composition further comprises carbidopa, entacapone, or both.

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