COMPOSITION AND METHOD FOR TREATING NEUROLOGICAL DISEASE

摘要

Disclosed are compositions comprising amantadine, or a pharmaceutically acceptable salt thereof, and one or more excipients, wherein at least one of the excipients modifies release of amantadine. Methods of administering the same are also provided.

主权项

1. A method comprising:
orally administering to a human subject with Parkinson's disease once-daily a composition consisting of (i) a drug selected from the group consisting of amantadine and pharmaceutically acceptable salts thereof, and (ii) at least one excipient,wherein at least 50% of the drug in the composition is in an extended release form, andwherein the composition has an in vitro dissolution profile ranging between 35% and 55% in 2 hours, 60% and 80% in 4 hours, and greater than 90% in 8 hours using a USP type 2 (paddle) dissolution system at 50 rpm at a temperature of 37±0.5° C. in water, andwherein the daily dose of drug administered to the human subject is 200 to 500 mg.