Controlled release formulations of levodopa and uses thereof
AssigneeImpax Laboratories, LLC
InventorsAnn Hsu, Jim H. Kou, Laman Lynn Alani
Life of this patent
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Abstract
The current invention provides a controlled release oral solid formulation of levodopa comprising levodopa, a decarboxylase inhibitor, and a carboxylic acid. Also provided by this invention is multiparticulate, controlled release oral solid formulations of levodopa comprising: i) a controlled release component comprising a mixture of levodopa, a decarboxylase inhibitor and a rate controlling excipient; ii) a carboxylic acid component; and iii) an immediate release component comprising a mixture of levodopa and a decarboxylase inhibitor.
Claims9
A method of reducing motor fluctuations in a patient suffering from Parkinson's disease comprising administering to the patient an effective amount of a controlled release oral solid formulation of levodopa comprising:
- (a) levodopa;
- (b) a decarboxylase inhibitor;
- and (c) a carboxylic acid that is not (a) or (b);
- wherein the carboxylic acid of (c) is in a distinct bead from (a) or (b) thereby providing a plasma concentration of levodopa effective to reduce motor fluctuations in the patient.
A method of reducing off time in a patient suffering from Parkinson's disease comprising administering to the patient an effective amount of a controlled release oral solid formulation of levodopa comprising:
- (a) levodopa;
- (b) a decarboxylase inhibitor;
- and (c) a carboxylic acid that is not (a) or (b);
- wherein the carboxylic acid of (c) is in a distinct bead from (a) or (b) thereby providing a plasma or serum concentration of levodopa effective to reduce off time in the patient.
A method of increasing on time in a patient suffering from Parkinson's disease comprising administering to the patient an effective amount of a controlled release oral solid formulation of levodopa comprising:
- (a) levodopa;
- (b) a decarboxylase inhibitor;
- and (c) a carboxylic acid that is not (a) or (b);
- wherein the carboxylic acid of (c) is in a distinct bead from (a) or (b) thereby providing a plasma or serum concentration of levodopa effective to increase on time in the patient.
A method of enhancing dopamine levels in a subject suffering from a disease associated with reduced or impaired dopamine levels comprising administering to a subject an effective amount of a controlled release oral solid formulation of levodopa comprising:
- (a) levodopa;
- (b) a decarboxylase inhibitor;
- and (c) a carboxylic acid that is not (a) or (b);
- wherein the carboxylic acid of (c) is in a distinct bead from (a) or (b) thereby providing a plasma or serum concentration of levodopa effective to enhance dopamine levels in the subject suffering from a disease associated with reduced or impaired dopamine levels.
Dependencies are inferred from the claim text.