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US 2003/0224045 A1Published application
Combination immediate release sustained release levodopa/carbidopa dosage forms
OwnerChien-Hsuan Han, Larry Hsu +2inventors
InventorsChien-Hsuan Han, Larry Hsu, Richard Ting, Charles Hsiao
Life of this patent
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Abstract
Dosage forms containing both immediate release and sustained release components for the treatment of ailments associated with depleted amounts of dopamine in brain tissue of a patient. The dosage forms contain a combination of carbidopa and levodopa.
Claims8
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 1:2 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 90% Levodopa released after 30 minutes and from about 50% to about 99% after 1 hour;
- b) a controlled release component comprising a ratio of cabidopa to levodopa of from about 1:2 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 40% levodopa released after 1 hour;
- from about 25% to about 60% released after 2 hours;
- from about 40% to about 75% after 4 hours and from about 55% to about 90% after about 6 hours, the in vitro release rate being independent of pH between pH 1.6 and 7.2 and chosen such that the peak plasma level of levodopa obtained in vivo occurs between 1 and 6 hours after administration of the dosage form.
1 more element
A pharmaceutical dosage form having an immediate release component and a controlled release component comprising:
- a) an immediate release composition comprising a combination of levodopa and carbidopa in the form of a coating on a solid dosage form;
- b) a controlled release composition making up the solid dosage form comprising an active ingredient combination of levodopa and cabidopa together with a retarding agent of a type and amount sufficient to retard the release of active ingredient for a period of from about 1 hour to about 24 hours.
Dependencies are inferred from the claim text.