CONTROLLED RELEASE FORMULATIONS OF LEVODOPA AND USES THEREOF
First Claim
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1. A controlled release oral solid formulation of levodopa comprising:
- a. levodopa,b. a decarboxylase inhibitor, andc. a carboxylic acid that is not (a) or (b), wherein the carboxylic acid of (c) is in a distinct bead from (a) or (b).
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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.
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92 Claims
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1. A controlled release oral solid formulation of levodopa comprising:
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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). - View Dependent Claims (2, 3, 4, 5, 6, 7, 10, 13, 14, 15, 16, 18, 22, 55, 57, 58, 61, 63, 73, 77, 78, 79, 80, 81, 89, 91, 92)
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8-9. -9. (canceled)
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11-12. -12. (canceled)
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17. (canceled)
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19-21. -21. (canceled)
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23-24. -24. (canceled)
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25. The controlled release oral solid formulation of claim 211 comprising 10 to 80 mg of carbidopa.
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26-54. -54. (canceled)
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59-60. -60. (canceled)
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64-71. -71. (canceled)
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72. A controlled release oral solid formulation of levodopa having a median levodopa plasma or serum concentration profile comprising:
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a. a time of administration; b. a first concentration at a first time, that occurs within one hour of said time of administration; c. a second concentration at a second time, that occurs after said first time; d. a third concentration at a third time, that occurs at least four hours after said second time; wherein, said second concentration is equal to the maximum concentration of said profile;
said first concentration is equal to about fifty percent of said second concentration;
said third concentration is equal to about fifty percent of said second concentration.
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74-76. -76. (canceled)
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82-88. -88. (canceled)
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90. (canceled)
Specification