Composition and method for treating neurological disease
DCFirst Claim
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.
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Abstract
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.
118 Citations
9 Claims
- 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.
Specification