Method of administering amantadine prior to a sleep period
AssigneeAdamas Pharma, LLC
InventorsGregory T. Went, Gayatri Sathyan, Kavita Vermani, Gangadhara Ganapati, Michael Coffee, Efraim Shek, Ashok Katdare
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Abstract
Methods of nighttime administration of amantadine to reduce sleep disturbances in patient undergoing treatment with amantadine are described, as well as compositions of extended release amantadine that are suitable for nighttime administration.
Claims19
A method of administering a dose of a pharmaceutical composition of a drug, wherein the drug is selected from the group consisting of amantadine and pharmaceutically acceptable salts thereof, to a human patient in need thereof, comprising administering said dose of said pharmaceutical composition to said human patient orally, once daily 0 to 4 hours before bedtime, wherein said dose of said pharmaceutical composition comprises:
- (i) 220 mg to 455 mg of the drug;
- and (ii) one or more excipients, wherein at least one of said one or more excipients modifies the release of said drug to provide an extended release dosage form,
- wherein, a unit dosage form of said pharmaceutical composition has an in vitro dissolution profile characterized by release of said drug from said pharmaceutical composition that is not more than 25% in two hours and at least 80% at 12 hours using a USP Apparatus II (Paddles) at 50 rpm with 500 ml water at 37° C. as the dissolution medium, and
- wherein when said pharmaceutical composition is dosed in a single dose, fasted, human pharmacokinetic study in healthy subjects, the Tmax for amantadine is 8 to 20 hours.
Dependencies are inferred from the claim text.