Dopa decarboxylase inhibitor compositions
AssigneeNeuroDerm, Ltd.
InventorOron Yacoby-Zeevi
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Abstract
Disclosed herein are formulations containing carbidopa and optionally levodopa, arginine, and other components that have reduced levels of impurities and toxins, particularly degradation productions. Also disclosed herein are methods of treatment diseases or conditions relating to a loss of dopamine or dopaminergic neurons using such formulations, methods of making such formulations, and kits that include such formulations.
Claims24
A method for treating Parkinson's disease in a patient, the method comprising administering to the patient a pharmaceutically acceptable formulation in an amount effective to treat the Parkinson's disease in the patient, wherein the pharmaceutically acceptable formulation comprises:
- about 0.1% to about 10% by weight ascorbic acid or a pharmaceutically acceptable salt thereof;
- about 0.01% to about 1% by weight of a component selected from the group consisting of:
- NAC, L-cysteine, and pharmaceutically acceptable salts thereof;
- about 2% to about 16% by weight levodopa or an ester thereof;
- and
- about 0.6% to about 1.4% by weight carbidopa or an ester thereof, and
- wherein the pharmaceutically acceptable formulation has less than about 10 μg/ml of hydrazine, as determined by a gas chromatography-mass spectrometry (GCMS) method.
A method for treating Parkinson's disease, the method comprising substantially continuously subcutaneously administering to a patient in need thereof a liquid composition comprising:
- about 0.1% to about 10% by weight ascorbic acid or a pharmaceutically acceptable salt thereof;
- about 0.01% to about 1% by weight of a component selected from the group consisting of:
- NAC, L-cysteine, and pharmaceutically acceptable salts thereof;
- about 2% to about 16% by weight levodopa or an ester thereof;
- and
- about 0.6% to about 1.4% by weight carbidopa or an ester thereof, and
- wherein the method comprises administering less than 42 μg/day of hydrazine to the patient.
Dependencies are inferred from the claim text.