US2019247331A1PendingUtilityA1

Composition and method for treating neurological disease

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Assignee: OSMOTICA KERESKEDELMI ES SZOLGALTATO KORLATOLT FELELOSSEGU TARSASAGPriority: Feb 15, 2018Filed: Feb 5, 2019Published: Aug 15, 2019
Est. expiryFeb 15, 2038(~11.6 yrs left)· nominal 20-yr term from priority
Inventors:Glenn A. MeyerJoaquina FaourAna C. PastiniMarcelo Fernando Befumo
A61P 25/16A61K 45/06A61K 31/13A61K 9/2886A61K 9/20A61K 9/0004
52
PatentIndex Score
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Claims

Abstract

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.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         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.

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