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US 7,094,427 B2Granted
Combination immediate release controlled release levodopa/carbidopa dosage forms
AssigneeImpax Laboratories, LLC
InventorsChien-Hsuan Han, Larry Hsu, Ann F. Hsu
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Abstract
The present invention relates to dosage forms of a combination of carbidopa and levodopa comprising both immediate release and controlled release components for the treatment of ailments associated with depleted amounts of dopamine in a patient's brain tissue.
Claims31
A pharmaceutical dosage form having an immediate release component and a controlled release component comprising:
- a) an immediate release component comprising a ratio of carbidopa to levodopa of from about 1:1 to about 1:50 such that the in vitro dissolution rate of the immediate release component according to measurements under the USP paddle method of 50 rpm in 900 ml aqueous buffer at pH 4 at 37° C. is from about 10% to about 99% levodopa released after 15 minutes and from about 60% to about 99% after 1 hour;
- and
- b) a controlled release component comprising a ratio of carbidopa to levodopa of from about 1:1 to about 1:50 such that the in vitro dissolution rate of the controlled release component according to measurements under the USP paddle method of 50 rpm in 900 ml aqueous buffer at pH 4 at 37° C. is from about 10% to about 60% levodopa released after 1 hour;
- from about 20% to about 80% levodopa eased after 2 hours;
- and from about 30% to about 99% levodopa released after about 6 hours, the in vitro release rate chosen such that the initial peak plasma level of levodopa obtained in vivo occurs between 0.1 and 6 hours after administration of the dosage form to a patient.
2 more elements
Dependencies are inferred from the claim text.