Patent ID: 7094427
Filing Date: 2006-08-22
Classification: A61K,A61P

Abstract:
1. 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.