COMPOSITION AND METHOD FOR TREATING NEUROLOGICAL DISEASE
The present disclosure is directed to methods of treating neurological disorders in a patient such as Parkinson's disease, drug-induced extrapyramidal reactions, and/or levodopa-induced dyskinesia comprising administering to the patient once daily in the morning a pharmaceutical composition comprising about 50 mg to about 400 mg of extended-release amantadine or a pharmaceutically acceptable salt thereof.
1 . A solid oral 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 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, and
wherein said solid oral dosage form has one or more of the, following dimensions:
(a) a volume of about 0.2 mL 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 dosage form is about 8 mm to about 15 mm.
2 . The solid oral dosage form of claim 1 , wherein said solid oral dosage form has a volume of about 0.24 mL to about 0.56 mL.
3 . The solid oral dosage form of claim 2 , wherein said solid oral dosage form has a volume of about 0.4 mL.
4 . The solid oral dosage form of claim 1 , wherein said solid oral dosage form has a wall height of about 3.5 mm to about 5 mm.
5 . The solid oral dosage form of claim 4 , wherein said solid oral dosage form has a wall height of about 4 mm.
6 . The solid oral dosage form of claim 1 , wherein the largest dimension of said solid oral dosage form is about 11 ruin to about 14 mm.
7 . The solid oral dosage form of claim 6 , wherein the largest dimension of said solid oral dosage form is about 11.2 mm.
8 . The solid oral dosage form of claim 1 , wherein said solid oral dosage form has a volume of about 0.4 mL, a wall height of about 4 mm, and the largest dimension of said solid oral dosage form is about 11.2 mm.
9 . A solid oral 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 dosage form comprises about 193 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, and
wherein said solid oral dosage form has one or more of the following dimensions:
(a) a volume of about 0.1 mL to about 0.5 mL;
(b) a wall height of about 3 mm to about 6 mm; and
(c) the largest dimension of said solid oral dosage form is about 8 mm to about 14 mm.
10 . The solid oral dosage form of claim 9 , wherein said solid oral dosage form has a volume of about 0.18 mL to about 0.42 mL.
11 . The solid oral dosage form of claim 10 , wherein said solid oral dosage form has a volume of about 0.30 mL.
12 . The solid oral dosage form of claim 9 , wherein said solid oral dosage form has a wall height of about 3.5 mm to about 5 mm.
13 . The solid oral dosage form of claim 12 , wherein said solid oral dosage form has a wall height of about 4 mm.
14 . The solid oral dosage form of claim 9 , wherein the largest dimension of said solid oral dosage form is about 10 mm to about 13 mm.
15 . The solid oral dosage form of claim 14 , wherein the largest dimension of said solid oral dosage form is about 10.2 mm.
16 . The solid oral dosage form of claim 9 , wherein said solid oral dosage form has a volume of about 0.3 mL, a wall height of about 4 mm, and the largest dimension of said solid oral dosage form is about 10.2 mm.
17 . A solid oral 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 dosage form comprises about 129 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, and
wherein said solid oral dosage form has one or more of the following dimensions:
(a) a volume of about 0.1 mL to about 0.4 mL;
(b) a wall height of about 3 mm to about 6 mm; and
(c) the largest dimension of said solid oral dosage form is about 6 mm to about 10 mm.
18 . The solid oral dosage form of claim 17 , wherein said solid oral dosage form has a volume of about 0.12 mL to about 0.28 mL.
19 . The solid oral dosage form of claim 8 , wherein said solid oral dosage form has a volume of about 0.20 mL.
20 . The solid oral dosage form of claim 17 , wherein said solid oral dosage form has a wall height of about 3.5 mm to about 5 mm.
21 . The solid oral dosage form of claim 20 , wherein said solid oral dosage for has a wall height of about 4 mm.
22 . The solid oral dosage form of claim 17 , wherein the largest dimension of said solid oral dosage form is about 8 mm to about 10 mm.
23 . The solid oral dosage form of claim 22 , wherein the largest dimension of said solid oral dosage form is about 8.1 mm.
24 . The solid oral dosage form of claim 17 , wherein said solid oral dosage form has a volume of about 0.2 mL, a wall height of about 4 mm, and the largest dimension of said solid oral dosage form is about 8.1 mm.
25 . The solid oral dosage form of claim 1 , wherein the dosage form is a tablet.
26 . The solid oral dosage form of claim 1 , wherein the dosage form is a capsule.
27 . The solid oral dosage form of claim 9 , wherein the dosage form is a tablet.
28 . The solid oral dosage form of claim 9 , wherein the dosage form is a capsule.
29 . The solid oral dosage form of claim 17 , wherein the dosage form is a tablet.
30 . The solid oral dosage form of claim 17 , wherein the dosage form is a capsule.