FORMULATION CONTAINING CARBIDOPA, LEVODOPA, AND ENTACAPONE

摘要

Disclosed herein are stable pharmaceutical dosage forms containing carbidopa, levodopa, and entacapone. The dosage forms are prepared by mixing carbidopa, levodopa, and entacapone and forming granules. In some embodiments the granules also include starch. Microcrystalline cellulose can be added as an extragranular excipient. The stable pharmaceutical dosage forms have a bioavailability that is substantially similar to a dosage form prepared by adding a substantial portion of carbidopa separately from levodopa and entacapone.

主权项

1. A process for preparing a stable pharmaceutical dosage form comprising:
a. mixing carbidopa, levodopa, and entacapone, or pharmaceutically acceptable salts, solvates, or hydrates thereof, and an optional first excipient to form a first mixture; b. granulating the first mixture with a granulation solution to form a granulation mixture; c. drying the granulation mixture to form dried granules comprising carbidopa, levodopa, and entacapone, or pharmaceutically acceptable salts, solvates, or hydrates thereof; d. combining the dried granules with at least one second excipient to form a second mixture; and e. compressing the second mixture into said stable pharmaceutical dosage form;wherein the pharmaceutical dosage form is stable when exposed to atmospheric conditions of 40° C. and 75% relative humidity.