Patent ID: 9642810
Date: 2017-05-09
CPC Classifications: A61K,A61P

Claim:
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.