US2022040161A1PendingUtilityA1

Sustained release aminopyridine composition

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Assignee: ACORDA THERAPEUTICS INCPriority: Dec 11, 2003Filed: Oct 26, 2021Published: Feb 10, 2022
Est. expiryDec 11, 2023(expired)· nominal 20-yr term from priority
A61K 47/12A61K 47/44A61K 31/44A61K 47/14A61K 31/4409A61K 9/2077A61P 19/00A61P 25/28A61K 9/2054A61K 47/38A61P 25/00A61P 43/00A61K 9/20
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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 - 8 . (canceled) 
     
     
         9 . A method of treating a disease associated with a neurological disorder, said method comprising:
 administering an aminopyridine on a dosing regimen to obtain an in vivo C max :C τ  ratio of 1.0 to 3.5 and a C avSS  of about 15 ng/ml to about 35 ng/ml.   
     
     
         10 . The method of  claim 9  wherein said C max :C τ  ratio is about 1.5 to about 3.0. 
     
     
         11 . The method of  claim 9  wherein said C max :C τ  ratio is about 2.0 to about 3.0. 
     
     
         12 . The method of  claim 9  wherein said neurological disorder comprises a spinal cord injury, Alzheimer's disease, multiple sclerosis, or amyotrophic lateral sclerosis. 
     
     
         13 . The method of  claim 9  wherein said neurological disorder comprises a spinal cord injury. 
     
     
         14 . The method of  claim 9  wherein said neurological disorder comprises multiple sclerosis. 
     
     
         15 . The method of  claim 9  wherein said dosing regimen is comprised of administering a tablet twice daily. 
     
     
         16 . The method of  claim 15  wherein said twice daily administration comprises every twelve hours. 
     
     
         17 . The method of  claim 9  wherein said aminopyridine comprises 4-aminopyridine. 
     
     
         18 - 23 . (canceled)

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