Composition and method for treating neurological disease
View Patent ↗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 dosage form suitable for once-daily administration to a human subject consisting of (i) 50 mg 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 50% of the drug in the dosage form is in an extended release form, and wherein the dosage form provides a mean change in amantadine plasma concentration as a function of time (dC/dT) as measured in a single dose human pharmacokinetic study over the time period between 2 hours and 4 hours after administration that is less than 30% of the dC/dT provided by the same quantity of the drug in an immediate release form as measured in a single dose human pharmacokinetic study over the time period between 0 and 2 hours after administration.
2. The dosage form of claim 1 , comprising an osmotic device, which utilizes an osmotic driving force to provide extended release of amantadine.
3. The dosage form of claim 1 , wherein the amount of drug is 100 to 500 mg.
4. The dosage form of claim 1 , wherein the amount of drug is 200 to 500 mg.
5. The dosage form of claim 1 , wherein at least 75% of the drug in the dosage form is in an extended release form.
6. The dosage form of claim 1 , wherein at least 90% of the drug in the dosage form is in an extended release form.
7. The dosage form of claim 1 , wherein the dosage form 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.
8. The dosage form of claim 1 , wherein the extent of drug bioavailability is maintained.
9. The dosage form of claim 1 , wherein the dosage form additionally comprises the drug in an immediate release form.