COMPOSITION AND METHOD FOR TREATING NEUROLOGICAL DISEASE
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.
1 . A composition suitable for once daily oral administration to a human subject consisting of (i) 50 to 500 mg of a drug selected from the group consisting of amantadine and pharmaceutically acceptable salts thereof, and (ii) at least one excipient,
wherein at least one of said excipients is a release modifying excipient, and
wherein at least 50% of said drug is in an extended release form, and
wherein administration of the composition once daily provides a steady state plasma concentration of about 3 μM.
2 . A composition suitable for once daily oral administration to a human subject consisting of (i) 50 to 500 mg of a drug selected from the group consisting of amantadine and pharmaceutically acceptable salts thereof, and (ii) at least one excipient,
wherein at least one of said excipients is a release modifying excipient, and
wherein at least 50% of said drug is in an extended release form, and
wherein administration of the composition once daily provides a steady state plasma concentration of about 0.5 μg/ml.
3 . The composition of claim 1 or 2 , wherein at least 75% of the drug in the composition is in an extended release form.
4 . The composition of claim 1 or 2 , wherein at least 90% of the drug in the composition is in an extended release form.
5 . The composition of claim 1 or 2 , wherein at least some of the drug in the composition is in an immediate release form.
6 . The composition of claim 1 or 2 , wherein the amount of drug is 100 mg to 500 mg.
7 . The composition of claim 1 or 2 , wherein the amount of drug is 200 mg to 500 mg.
8 . The composition of claim 1 or 2 , wherein the amount of drug is 300 mg to 500 mg.
9 . The composition of claim 1 or 2 , wherein the composition provides a shift in amantadine Tmax of 2 hours to 16 hours relative to an immediate release form of amantadine, wherein the Tmax is measured in a single dose human pharmacokinetic study.
10 . The composition of claim 1 or 2 , wherein the extended release form comprises an osmotic device which utilizes an osmotic driving force to provide extended release of the drug.
11 . The composition of claim 1 or 2 , wherein the extent of drug bioavailability is maintained.