US2019125708A1PendingUtilityA1

Continuous Administration of Dopa Decarboxylase Inhibitors and Compositions for Same

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Assignee: NEURODERM LTDPriority: May 19, 2009Filed: May 30, 2018Published: May 2, 2019
Est. expiryMay 19, 2029(~2.8 yrs left)· nominal 20-yr term from priority
A61P 43/00A61P 25/16A61P 25/28A61P 25/14A61P 25/00A61P 21/00A61K 47/22A61K 31/198A61K 9/08C07C 243/18A61K 31/12A61K 31/277A61K 47/183A61K 31/15A61K 9/0053C07C 279/14A61K 9/0019A61K 9/0014A61K 31/195A61K 9/20
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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 - 17 . (canceled) 
     
     
         18 . A pharmaceutically acceptable liquid composition comprising about 0.5% to about 20% by weight carbidopa, about 1% to about 20% by weight arginine, and one or more antioxidants,
 wherein the pH of the composition at 25° C. is about 6.5 to about 9.5, and   wherein the composition is stable at 25° C. for 24 hours or more.   
     
     
         19 . The composition of  claim 18 , comprising about 2% to about 10% by weight carbidopa. 
     
     
         20 . The composition of  claim 18 , comprising about 2% to about 6% by weight carbidopa. 
     
     
         21 . The composition of  claim 18 , wherein the pH of the composition at 25° C. is selected from the group consisting of: about pH 7 to about pH 9 and about pH 8 to about pH 9. 
     
     
         22 . The composition of  claim 18 , wherein the composition is stable at 25° C. for about 48 hours or about 7 days. 
     
     
         23 . The composition of  claim 18 , wherein the one or more antioxidants is selected from the group consisting of: N-acetyl cysteine, sodium bisulfite, glutathione, and ascorbic acid. 
     
     
         24 . The composition of  claim 23 , comprising about 0% to about 5% by weight of N-acetyl cysteine and about 0% to about 5% by weight of ascorbic acid. 
     
     
         25 . A method of treating a disease or disorder characterized by a reduced level of dopamine in the brain of a patient, the method comprising:
 administering substantially continuously to the patient a therapeutically effective amount of the composition of claim  1 ; and   administering a composition comprising a therapeutically effective amount of levodopa or a pharmaceutically acceptable salt thereof.   
     
     
         26 . The method of  claim 25 , wherein the disease or disorder is selected from the group consisting of: restless leg syndrome, Parkinson's disease, secondary parkinsonism, Huntington's disease, Parkinson's like syndrome, progressive supranuclear palsy (PSP), multiple system atrophy (MSA), amyotrophic lateral sclerosis (ALS), Shy-Drager syndrome, a condition resulting from brain injury, carbon monoxide intoxication, and manganese intoxication. 
     
     
         27 . The method of  claim 25 , wherein the pharmaceutically acceptable salt of levodopa is an arginine salt of levodopa. 
     
     
         28 . The method of  claim 25 , wherein the administering substantially continuously is transdermal, intradermal, subcutaneous, intravenous, oral, or intraduodenal.

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