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 . A composition suitable for once daily oral administration to a human subject consisting of (i) 50 to 500 mg of a drug selected from the group consisting of amantadine and pharmaceutically acceptable salts thereof, and (ii) at least one excipient,
 wherein at least one of said excipients is a release modifying excipient, and   wherein at least 50% of said drug is in an extended release form, and   wherein administration of the composition once daily provides a steady state plasma concentration of about 3 μM.   
     
     
         2 . A composition suitable for once daily oral administration to a human subject consisting of (i) 50 to 500 mg of a drug selected from the group consisting of amantadine and pharmaceutically acceptable salts thereof, and (ii) at least one excipient,
 wherein at least one of said excipients is a release modifying excipient, and   wherein at least 50% of said drug is in an extended release form, and   wherein administration of the composition once daily provides a steady state plasma concentration of about 0.5 μg/ml.   
     
     
         3 . The composition of  claim 1  or  2 , wherein at least 75% of the drug in the composition is in an extended release form. 
     
     
         4 . The composition of  claim 1  or  2 , wherein at least 90% of the drug in the composition is in an extended release form. 
     
     
         5 . The composition of  claim 1  or  2 , wherein at least some of the drug in the composition is in an immediate release form. 
     
     
         6 . The composition of  claim 1  or  2 , wherein the amount of drug is 100 mg to 500 mg. 
     
     
         7 . The composition of  claim 1  or  2 , wherein the amount of drug is 200 mg to 500 mg. 
     
     
         8 . The composition of  claim 1  or  2 , wherein the amount of drug is 300 mg to 500 mg. 
     
     
         9 . The composition of  claim 1  or  2 , wherein the composition provides a shift in amantadine Tmax of 2 hours to 16 hours relative to an immediate release form of amantadine, wherein the Tmax is measured in a single dose human pharmacokinetic study. 
     
     
         10 . The composition of  claim 1  or  2 , wherein the extended release form comprises an osmotic device which utilizes an osmotic driving force to provide extended release of the drug. 
     
     
         11 . The composition of  claim 1  or  2 , wherein the extent of drug bioavailability is maintained.