发明名称 |
Composition and method for treating neurological disease |
摘要 |
A method of administering amantadine is provided. The method comprises orally administering to a subject a pharmaceutical composition comprising amantadine, or a pharmaceutically acceptable salt thereof, and one or more excipients, wherein at least one of the excipients modifies release of the amantadine. A dose of the composition provides a mean change in amantadine plasma concentration as a function of time (dC/dT) that is less than 40% of the change in amantadine plasma concentration provided by a dose of the same quantity of an immediate release form of amantadine. The change in plasma concentration over time (dC/dT) is measured in a single dose human pharmacokinetic study in a defined time period of 0 to 4 hours after administration. The amantadine, or pharmaceutically acceptable salt thereof, is administered once daily at a dose of 300 to 500 mg per day. |
申请公布号 |
US8895614(B2) |
申请公布日期 |
2014.11.25 |
申请号 |
US201414328440 |
申请日期 |
2014.07.10 |
申请人 |
Adamas Pharmaceuticals, Inc. |
发明人 |
Went Gregory T.;Fultz Timothy J.;Porter Seth;Meyerson Laurence R.;Burkoth Timothy S. |
分类号 |
A61K31/13;A61K31/195 |
主分类号 |
A61K31/13 |
代理机构 |
Wilson Sonsini Goodrich & Rosati |
代理人 |
Wilson Sonsini Goodrich & Rosati |
主权项 |
1. A dosage form suitable for once-daily oral 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) that is less than 40% of the dC/dT provided by the same quantity of the drug in an immediate release form, wherein the dC/dT values are measured in a single dose human pharmacokinetic study over the time period between 0 and 4 hours after administration. |
地址 |
Emeryville CA US |