US2010272796A1PendingUtilityA1

Sustained release aminopyridine composition

74
Assignee: CUNNINGHAM SEANPriority: Dec 11, 2003Filed: Nov 25, 2009Published: Oct 28, 2010
Est. expiryDec 11, 2023(expired)· nominal 20-yr term from priority
Inventors:Sean CunninghamSeamus MulliganMichael Myers
A61P 43/00A61P 25/00A61P 25/28A61P 19/00A61K 31/4409A61K 9/2077A61K 31/44A61K 47/44A61K 47/14A61K 9/2054A61K 9/20A61K 47/12A61K 47/38
74
PatentIndex Score
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Cited by
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References
0
Claims

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.

Claims

exact text as granted — not AI-modified
1 .- 23 . (canceled) 
     
     
         24 . A sustained release composition comprising:
 4-aminopyridine and a sustained release matrix;   wherein the 4-aminopyridine is dispersed in the matrix; and   wherein the 4-aminopyridine is less than 5% by weight of the composition.   
     
     
         25 . The sustained release composition of  claim 24 , wherein the 4-aminopyridine is from 0.5% by weight of the composition to 4.75% by weight of the composition. 
     
     
         26 . The sustained release composition of  claim 24 , wherein the sustained release matrix is configured to obtain a C max :C min  ratio in vivo of about 1.0 to about 3.5 with a 12 hour dosing interval. 
     
     
         26 . The sustained release composition of  claim 26 , wherein the sustained release matrix is configured to obtain a C max :C min  ratio is about 1.5 to about 3.0 with a 12 hour dosing interval. 
     
     
         28 . The sustained release composition of  claim 26 , wherein the sustained release matrix is configured to obtain a C max :C min  ratio is about 2.0 to about 3.0 with a 12 hour dosing interval. 
     
     
         29 . The sustained release composition-of  claim 24 , wherein the sustained release matrix is hydroxypropylmethylcellulose. 
     
     
         30 . The sustained release composition of  claim 24 , in tablet form. 
     
     
         31 . A capsule comprising the sustained release composition of  claim 24 . 
     
     
         32 . The sustained release composition of  claim 24 , in granule form. 
     
     
         33 . The sustained release composition of  claim 30 , wherein the tablet comprises a 4-aminopyridine content consisting essentially of 5 mg of 4-aminopyridine. 
     
     
         34 . The sustained release composition of  claim 30 , wherein the tablet comprises a 4-aminopyridine content consisting essentially of 7.5 mg of 4-aminopyridine. 
     
     
         35 . The sustained release composition of  claim 30 , wherein the tablet comprises a 4-aminopyridine content consisting essentially of 10 mg of 4-aminopyridine. 
     
     
         36 . The sustained release composition of  claim 30 , wherein the tablet comprises a 4-aminopyridine content consisting essentially of 12.5 mg of 4-aminopyridine. 
     
     
         37 . The sustained release composition of  claim 30 , wherein the tablet comprises a 4-aminopyridine content consisting essentially of 15 mg of 4-aminopyridine. 
     
     
         38 . The sustained release composition of  claim 24 , wherein the 4-aminopyridine is present from 0.5 milligrams to 80 milligrams. 
     
     
         39 . The sustained release composition of  claim 24 , wherein the 4-aminopyridine is present from 5 milligrams to 50 milligrams. 
     
     
         40 . The sustained release composition of  claim 24  further comprising a pharmaceutically acceptable excipient. 
     
     
         41 . The sustained release composition of  claim 24  further comprising an additional active ingredient. 
     
     
         42 . A sustained release aminopyridine composition comprising:
 4-aminopyridine; and   a sustained release matrix consisting essentially of a hydrophilic polymer.   
     
     
         43 . The sustained release aminopyridine composition of  claim 42 , wherein the 4-aminopyridine is present in the composition in an amount from 0.1% to 13% by weight of the composition. 
     
     
         44 . The sustained release aminopyridine composition of  claim 42 , wherein the 4-aminopyridine is present in the composition in an amount from 0.5% to 6.25% by weight of the composition. 
     
     
         45 . The sustained release aminopyridine composition of  claim 42 , wherein the 4-aminopyridine is present in the composition in an amount from 0.5% to 4.75% by weight of the composition. 
     
     
         46 . The sustained release composition of  claim 42 , wherein the 4-aminopyridine is present in the composition in an amount less than 5% by weight of the composition. 
     
     
         47 . The sustained release composition of  claim 42 , wherein the hydrophilic polymer is hydroxypropylmethylcellulose. 
     
     
         48 . The sustained release composition of  claim 42 , wherein the 4-aminopyridine is dispersed in the sustained release matrix. 
     
     
         49 . The sustained release composition of  claim 42 , wherein the 4-aminopyridine is homogeneously dispersed in the sustained release matrix. 
     
     
         50 . A capsule comprising the sustained release composition of  claim 42 . 
     
     
         51 . The sustained release composition of  claim 42 , in granule form. 
     
     
         52 . The sustained release composition of  claim 42 , in tablet form. 
     
     
         53 . The sustained release composition of  claim 52 , wherein the tablet comprises a 4-aminopyridine content consisting essentially of 5 mg of 4-aminopyridine. 
     
     
         54 . The sustained release composition of  claim 52 , wherein the tablet comprises a 4-aminopyridine content consisting essentially of 7.5 mg of 4-aminopyridine. 
     
     
         55 . The sustained release composition of  claim 52 , wherein the tablet comprises a 4-aminopyridine content consisting essentially of 10 mg of 4-aminopyridine. 
     
     
         56 . The sustained release composition of  claim 52 , wherein the tablet comprises a 4-aminopyridine content consisting essentially of 12.5 mg of 4-aminopyridine. 
     
     
         57 . The sustained release composition of  claim 52 , wherein the tablet comprises a 4-aminopyridine content consisting essentially of 15 mg of 4-aminopyridine. 
     
     
         58 . The sustained release composition of  claim 42 , wherein the 4-aminopyridine is present from 0.5 milligrams to 80 milligrams. 
     
     
         59 . The sustained release composition of  claim 42 , wherein the 4-aminopyridine is present from 5 milligrams to 50 milligrams. 
     
     
         60 . The sustained release composition of  claim 42  further comprising a pharmaceutically acceptable excipient. 
     
     
         61 . The sustained release composition of  claim 42  further comprising an additional active ingredient. 
     
     
         62 . A sustained release aminopyridine composition comprising:
 a hydrophobic polymer; and   4-aminopyridine.   
     
     
         63 . The sustained release aminopyridine composition of  claim 62 , wherein the 4-aminopyridine is present in the composition in an amount from 0.1% to 13% by weight of the composition. 
     
     
         64 . The sustained release aminopyridine composition of  claim 62 , wherein the 4-aminopyridine is present in the composition in an amount from 0.5% to 6.25% by weight of the composition. 
     
     
         65 . The sustained release aminopyridine composition of  claim 62 , wherein the 4-aminopyridine is present in the composition in an amount from 0.5% to 4.75% by weight of the composition. 
     
     
         66 . The sustained release composition of  claim 62 , wherein the 4-aminopyridine is present in the composition in an amount less than 5% by weight of the composition. 
     
     
         67 . The sustained release composition of  claim 62 , wherein the 4-aminopyridine is dispersed in the sustained release matrix. 
     
     
         68 . The sustained release composition of  claim 62 , wherein the 4-aminopyridine is homogeneously dispersed in the sustained release matrix. 
     
     
         69 . The sustained release composition of  claim 62 , wherein the sustained release matrix further comprises a hydrophilic polymer. 
     
     
         70 . A capsule comprising the sustained release composition of  claim 62 . 
     
     
         71 . The sustained release composition of  claim 62 , in granule form. 
     
     
         72 . The sustained release composition of  claim 62 , in tablet form. 
     
     
         73 . The sustained release composition of  claim 72 , wherein the tablet comprises a 4-aminopyridine content consisting essentially of 5 mg of 4-aminopyridine. 
     
     
         74 . The sustained release composition of  claim 72 , wherein the tablet comprises a 4-aminopyridine content consisting essentially of 7.5 mg of 4-aminopyridine. 
     
     
         75 . The sustained release composition of  claim 72 , wherein the tablet comprises a 4-aminopyridine content consisting essentially of 10 mg of 4-aminopyridine. 
     
     
         76 . The sustained release composition of  claim 72 , wherein the tablet comprises a 4-aminopyridine content consisting essentially of 12.5 mg of 4-aminopyridine. 
     
     
         77 . The sustained release composition of  claim 72 , wherein the tablet comprises a 4-aminopyridine content consisting essentially of 15 mg of 4-aminopyridine. 
     
     
         78 . The sustained release composition of  claim 62 , wherein the 4-aminopyridine is present from 0.5 milligrams to 80 milligrams. 
     
     
         79 . The sustained release composition of  claim 62 , wherein the 4-aminopyridine is present from 5 milligrams to 50 milligrams. 
     
     
         80 . The sustained release composition of  claim 62  further comprising a pharmaceutically acceptable excipient. 
     
     
         81 . The sustained release composition of  claim 62  further comprising an additional active ingredient.

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