Sustained release aminopyridine composition

Abstract

A pharmaceutical composition which comprises a therapeutically effective amount of a aminopyridine dispersed in a release matrix, including, for example, a composition that can be formulated into a stable, sustained-release oral dosage formulation, such as a tablet which provides, upon administration to a patient, a therapeutically effective plasma level of the aminopyridine for a period of at least 12 hours, preferably 24 hours or more and the use of the composition to treat various neurological diseases.

1 .- 23 . (canceled) 
     
     
         24 . A pharmaceutical composition comprising:
 a sustained release composition and a di-aminopyridine.   
     
     
         25 . The pharmaceutical composition of  claim 24 , wherein the sustained release composition comprises a sustained release matrix. 
     
     
         26 . The pharmaceutical composition of  claim 25 , wherein said di-aminopyridine is dispersed in said sustained release matrix. 
     
     
         27 . The pharmaceutical composition of  claim 25 , wherein said di-aminopyridine is homogeneously dispersed in said sustained release matrix. 
     
     
         28 . The pharmaceutical composition of  claim 24 , wherein said di-aminopyridine is selected from 2,3-diaminopyridine, 2,5-diaminopyridine, 2,6-diaminopyridine, 3,4-diaminopyridine, 4,5-diaminopyridine and 4,6-diaminopyridine. 
     
     
         29 . The pharmaceutical composition of  claim 24 , wherein said di-aminopyridine is 3,4-diaminopyridine. 
     
     
         30 . The pharmaceutical composition of  claim 24 , wherein said sustained release composition is a hydrophilic polymer. 
     
     
         31 . The pharmaceutical composition of  claim 24 , wherein said sustained release composition is hydroxypropylmethylcellulose. 
     
     
         32 . The pharmaceutical composition of  claim 24 , wherein said sustained release composition is a hydrophobic polymer. 
     
     
         33 . The pharmaceutical composition of  claim 24 , wherein said sustained release composition is a hydrophobic polymer and a hydrophilic polymer. 
     
     
         34 . The pharmaceutical composition of  claim 24 , wherein said pharmaceutical composition is selected from a tablet, capsule and granule. 
     
     
         35 . The pharmaceutical composition of  claim 24 , wherein said pharmaceutical composition is a tablet. 
     
     
         36 . The pharmaceutical composition of  claim 24  further comprising a pharmaceutically acceptable excipient. 
     
     
         37 . The pharmaceutical composition of  claim 24  further comprising an additional active ingredient. 
     
     
         38 . The pharmaceutical composition of  claim 24 , wherein said pharmaceutical composition comprises a therapeutically effective amount of said di-aminopyridine. 
     
     
         39 . The pharmaceutical composition of  claim 24 , wherein said di-aminopyridine comprises about 0.1% to about 13% by weight of said pharmaceutical composition. 
     
     
         40 . The pharmaceutical composition of  claim 24 , wherein said di-aminopyridine comprises about 0.5% to about 6.25% by weight of said pharmaceutical composition. 
     
     
         41 . The pharmaceutical composition of  claim 24 , wherein said di-aminopyridine comprises about 0.5% to about 4.75% by weight of said pharmaceutical composition. 
     
     
         42 . The pharmaceutical composition of  claim 24 , wherein said 4-aminopyridine is present in said pharmaceutical composition from 0.5 milligrams to 80 milligrams. 
     
     
         43 . The composition of claim  1 , wherein said 4-aminopyridine is present in said pharmaceutical composition from 5 milligrams to 50 milligrams.