Composition and method for treating neurological disease

Abstract

Disclosed are compositions comprising amantadine, or a pharmaceutically acceptable salt thereof, and one or more excipients, wherein at least one of the excipients modifies release of amantadine. Methods of administering the same are also provided.

What is claimed is: 
     
         1 .- 11 . (canceled) 
     
     
         12 . A method of treating dyskinesia in a patient with Parkinson's disease, comprising orally administering to said patient, once daily, a pharmaceutical composition consisting of: (i) 200 mg to 500 mg of a drug selected from the group consisting of amantadine and pharmaceutically acceptable salts thereof; and (ii) one or more excipients, wherein at least one of said one or more excipients modifies the release of said drug to provide an extended release form,
 wherein said pharmaceutical composition has an in vitro dissolution profile in water of 0.1% to 20% in one hour, 70% or greater in 10 hours, and 90% or greater in 12 hours as determined using a USP type II (paddle) dissolution system at 50 rpm at a temperature of 37±0.5° C., and   wherein said pharmaceutical composition, when dosed in a single dose, fasted human pharmacokinetic study in healthy subjects has a Tmax of 5 to 19 hours.   
     
     
         13 . The method of  claim 12 , wherein said pharmaceutical composition has an in vitro dissolution profile in water of less than 10% in 30 minutes and more than 95% in 16 hours as determined using a USP type II (paddle) dissolution system at 50 rpm at a temperature of 37±0.5° C. 
     
     
         14 . The method of  claim 12 , wherein said pharmaceutical composition, when dosed in a single dose, fasted human pharmacokinetic study in healthy subjects has a Tmax of 7 to 19 hours. 
     
     
         15 . The method of  claim 12 , wherein said patient is also taking levodopa. 
     
     
         16 . The method of  claim 12 , wherein said dyskinesia is levodopa induced dyskinesia. 
     
     
         17 . The method of  claim 12 , wherein said dyskinesia is reduced. 
     
     
         18 . The method of  claim 12 , wherein said one or more excipients comprises a coating layer comprising (i) 15% to 85% by weight of a water insoluble polymer, (ii) a water soluble pore forming material, and (iii) 0% to 50% by weight of a plasticizer. 
     
     
         19 . The method of  claim 12 , wherein said composition is encapsulated.