|Title:||Controlled release combination of carbidopa/levodopa|
|Abstract:||A matrix or monolithic drug delivery system for the controlled release of carbidopa and levodopa consists of the two drugs uniformly dispersed in a polymer vehicle at a concentration that is greater than the solubility of either drug in the polymer. Treatment of parkinsonism with the controlled release formulation provides several advantages over treatment with the standard carbidopa/levodopa combinations presently employed.|
|Inventor(s):||Dempski; Robert E. (Dresher, PA), Scholtz; Edward C. (King of Prussia, PA), Nibbelink; Donald W. (Lansdale, PA), Reines; Scott A. (New Hope, PA)|
|Assignee:||Merck & Co., Inc. (Rahway, NJ)|
1. A controlled release oral dosage formulation comprising a uniform dispersion of 25-100 mg of carbidopa, 100-400 mg of levodopa, 1-10 mg of a tablet lubricant and in mixture
thereof with a pharmaceutically acceptable dye, in a polymer vehicle comprising 5-25 mg of water-soluble hydroxypropyl cellulose polymer, and 2-50 mg of a less water-soluble polyvinyl acetate-crotonic acid copolymer, whereby following administration the
carbidopa and levodopa are released slowly and simultaneously from the formulation.
2. The formulation of claim 1 comprising 200 mg. of levodopa and 50 mg. of carbidopa or 100 mg. of levodopa and 25 mg. of carbidopa.
3. The formulation of claim 1 comprising 200 mg of levodopa, 50 mg of carbidopa, 5-6.5 mg of vinyl acetate-crotonic acid copolymer, and about 17 mg of hydroxypropyl cellulose.