Infusion and Injection Solution of Levodopa

Abstract

An infusion or injection solution of Levodopa containing at least 10 mg/mL of Levodopa, or at least 5 mg/mL of Levodopa together with at least 0.5 mg/mL of at least one inhibitor of a Levodopa-metabolising enzyme is disclosed. The solution further contains a buffer, a physiologically acceptable sugar, such as glucose, a physiologically acceptable acid, such as hydrochloric acid, and optionally a stabilizer, and has a pH of lower than or equal to 6. There are also described a disposable syringe containing an infusion or injection solution of Levodopa, optionally together with a Levodopa-metabolising enzyme, and an infusion pump cassette containing an infusion or injection solution of Levodopa optionally together with a Levodopa-metabolising enzyme.

1 - 16 . (canceled) 
     
     
         17 . An infusion or injection solution of Levodopa containing
 a1) at least 10 mg/mL of Levodopa, or   a2) at least 5 mg/mL of Levodopa together with at least 0.5 mg/mL of at least one inhibitor of a Levodopa-metabolising enzyme,   b) a buffer,   c) a physiologically acceptable sugar, and   d) a physiologically acceptable acid,   the pH of the solution being lower than or equal to 6.   
     
     
         18 . The infusion or injection solution according to  claim 17 , wherein the physiologically acceptable sugar is glucose. 
     
     
         19 . The infusion or injection solution according to  claim 17 , wherein the pH of the solution is in the range of 3 to 6. 
     
     
         20 . The infusion or injection solution according to  claim 17 , wherein the solution further comprises a stabilizer. 
     
     
         21 . The infusion or injection solution according to  claim 17 , wherein the volume of the solution is adapted for a single or continuous intravenous and/or subcutaneous and/or intrathekal administration. 
     
     
         22 . The infusion or injection solution according to  claim 17 , wherein the inhibitor of a Levodopa-metabolising enzyme is selected from the group consisting of dopa decarboxylase (DDC) inhibitors, catechol-o-methyltransferase (COMT) inhibitors, and monoamino oxidase (MAO-B) inhibitors. 
     
     
         23 . The infusion or injection solution according to  claim 22 , wherein the DDC-inhibitor is L-2-hydrazino-3-(3,4-dihydroxyphenyl)-2-methylpropanoic acid (carbidopa). 
     
     
         24 . The infusion or injection solution according to  claim 22 , wherein the DDC-inhibitor is 2-amino-3-hydroxy-N′-(2,3,4-trihydroxybenzyl)propionohydrazide (benserazide). 
     
     
         25 . The infusion or injection solution according to  claim 22 , wherein the COMT inhibitor is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propane amide (entacapone). 
     
     
         26 . The infusion or injection solution according to  claim 22 , wherein the MAO-B inhibitor is (R)—N,α-dimethyl-N-(2-propynyl)phenethyl amine (selegiline). 
     
     
         27 . The infusion or injection solution according to  claim 17 , wherein the physiologically acceptable acid is hydrochloric acid. 
     
     
         28 . The infusion or injection solution according to  claim 17 , wherein the physiologically acceptable acid is acetic acid. 
     
     
         29 . A disposable syringe containing a therapeutically effective amount of an infusion or injection solution of Levodopa dissolved in a physiologically acceptable acid, containing a buffer, a physiologically acceptable sugar and having a pH of lower than or equal to 6. 
     
     
         30 . The disposable syringe according to  claim 29 , further comprising at least one inhibitor of a Levodopa-metabolising enzyme in an amount that together with an amount of Levodopa gives a therapeutically effective amount of the solution. 
     
     
         31 . An infusion pump cassette containing a therapeutically effective amount of an infusion or injection solution of Levodopa dissolved in a physiologically acceptable acid, containing a buffer, a physiologically acceptable sugar and having a pH of lower than or equal to 6. 
     
     
         32 . The infusion pump cassette according to  claim 31 , further comprising at least one inhibitor of a Levodopa-metabolising enzyme in an amount that together with an amount of Levodopa gives a therapeutically effective amount of the solution.