US 11,833,121 B2
Composition and method for treating neurological disease
Glenn A. Meyer, Wilmington, NC (US); Joaquina Faour, Ciudad Autonoma de Buenos Aires (AR); Ana Cristina Pastini, Ciudad Autonoma de Buenos Aires (AR); and Marcelo Fernando Befumo, Ciudad Autonoma de Buenos Aires (AR)
Assigned to Adamas Pharmaceuticals, Inc., Rockville, MD (US)
Filed by ADAMAS PHARMACEUTICALS, INC., Emeryville, CA (US)
Filed on Dec. 22, 2020, as Appl. No. 17/131,323.
Application 17/131,323 is a continuation of application No. 16/268,373, filed on Feb. 5, 2019, abandoned.
Application 16/268,373 is a continuation in part of application No. 16/241,631, filed on Jan. 7, 2019, granted, now 10,500,170, issued on Dec. 19, 2019.
Application 16/241,631 is a continuation of application No. 15/898,143, filed on Feb. 15, 2018, granted, now 10,213,393, issued on Feb. 26, 2019.
Prior Publication US 2021/0353558 A1, Nov. 18, 2021
Int. Cl. A61K 31/13 (2006.01); A61K 9/00 (2006.01); A61K 45/06 (2006.01); A61K 9/20 (2006.01); A61P 25/16 (2006.01); A61K 9/28 (2006.01)
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.