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 pharmaceutical 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 50% of the drug in the composition is in an extended release form, and wherein the composition has an in vitro dissolution profile ranging between 35% and 55% in 2 hours, 60% and 80% in 4 hours, and greater than 90% in 8 hours using a USP type 2 (paddle) dissolution system at 50 rpm at a temperature of 37±0.5° C. in water.   
     
     
         2 . A pharmaceutical 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 50% of the drug in the composition is in an extended release form and the extended release form of the composition has an in vitro dissolution profile ranging between 35% and 55% in 2 hours, 60% and 80% in 4 hours, and greater than 90% in 8 hours using a USP type 2 (paddle) dissolution system at 50 rpm at a temperature of 37±0.5° C. in water.   
     
     
         3 . A pharmaceutical composition suitable for once daily oral administration to a human subject consisting
 (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 50% of the drug in the composition is in an extended release form and the extended release form of the composition has an in vitro dissolution profile ranging between 60% and 80% in 4 hours, and greater than 90% in 8 hours using a USP type 2 (paddle) dissolution system at 50 rpm at a temperature of 37±0.5° C. in water.   
     
     
         4 . The composition of any one of  claims 1  to  3 , wherein the extended release form comprises an osmotic device, which utilizes an osmotic driving force to provide extended release of amantadine. 
     
     
         5 . The composition of any one of  claims 1  to  3 , wherein the amount of drug is 100 to 500 mg. 
     
     
         6 . The composition of any one of  claims 1  to  3 , wherein the amount of drug is 200 to 500 mg. 
     
     
         7 . The composition of any one of  claims 1  to  3 , wherein at least 75% of the drug in the composition is in an extended release form. 
     
     
         8 . The composition of any one of  claims 1  to  3 , wherein at least 90% of the drug in the composition is in an extended release form. 
     
     
         9 . The composition of any one of  claims 1  to  3 , 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 any one of  claims 1  to  3 , wherein the extent of drug bioavailability is maintained. 
     
     
         11 . The composition of any one of  claims 1  to  3 , wherein at least some of the drug is in an immediate release form.