Method of administering amantadine prior to a sleep period

  • US 9,867,793 B2
  • Filed: 02/10/2017
  • Issued: 01/16/2018
  • Est. Priority Date: 12/02/2009
  • Status: Active Grant
First Claim
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1. A method of treating levodopa-induced dyskinesia (LID) in a human patient with Parkinson'"'"'s disease, comprising orally administering to said human patient with Parkinson'"'"'s disease and levodopa-induced dyskinesia, once daily 0 to 4 hours before bedtime, a pharmaceutical composition comprising 220 mg to 455 mg of a drug selected from the group consisting of amantadine and pharmaceutically acceptable salts thereof, in an extended release dosage form,wherein said extended release dosage form comprises one or more capsules each containing one or more pellets wherein each of said one or more pellets comprises:

  • a) a pellet core comprising said drug; and

    b) surrounding the pellet core, an extended release coating layer comprising an extended release coating polymer, a pore former, and a plasticizer,wherein said drug is present at a weight percent of from 40% to 80% based on the combined weight of said pellet core and said extended release coating layer,wherein said extended release coating layer is present at a weight percent from 10% to 30% based on the combined weight of said pellet core and said extended release coating layer,wherein said one or more capsules have an in vitro dissolution profile of said drug of not more than 10% at 1 hour, not more than 25% at 2 hours, and at least 80% at 12 hours, using a USP Apparatus II (Paddles) at 50 rpm with 500 ml of water at 37°

    C. as the dissolution medium, andwherein the extended release dosage form has a Tmax for amantadine of 8 hours to 18 hours when the Tmax of the extended release form is determined in a fasted single dose human pharmacokinetic study.

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