CPC A61K 31/13 (2013.01) [A61K 9/0004 (2013.01); A61K 9/20 (2013.01); A61K 9/2886 (2013.01); A61K 45/06 (2013.01); A61P 25/16 (2018.01)] | 16 Claims |
1. A solid oral tablet dosage form comprising i) amantadine or a pharmaceutically acceptable salt thereof in an extended release form, and ii) amantadine or a pharmaceutically acceptable salt thereof in an immediate release form,
wherein said solid oral tablet dosage form comprises about 258 mg of amantadine free base equivalent,
wherein at least about 50% of amantadine or a pharmaceutically acceptable salt thereof is in an extended release form,
wherein said solid oral tablet dosage form has one or more of the following dimensions:
(a) a volume of about 0.2 m L to about 0.6 mL;
(b) a wall height of about 3 mm to about 6 mm; and
(c) the largest dimension of said solid oral tablet dosage form is from more than 8 mm to about 15 mm, and wherein the dosage form provides a mean change in amantadine plasma concentration as a function of time (dC/dT) that is between about 40% and about 70% of the dC/dT provided by the same quantity of amantadine or a pharmaceutically acceptable salt thereof 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.
|