Sustained release aminopyridine composition
AssigneeAlkermes Pharma Ireland Limited
InventorsSean Cunningham, Seamus Mulligan, Michael Myers
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Abstract
A pharmaceutical composition which comprises a therapeuticallly 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.
Claims23
A sustained release tablet comprising:
- a sustained release matrix and an aminopyridine, said tablet exhibiting a release profile to obtain a Cmax:C ratio in vivo of about 1.0 to about 3.5 and a predetermined CavSS.
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 Cmax:C ratio of 1.0 to 3.5 and a CavSS of about 15 ng/ml to about 35 ng/ml.
A therapeutic composition comprised of a release matrix and an active aminopyridine, said aminopyridine being released from said release matrix at a rate to maintain an in vivo Cmax:C ratio of 1.0 to 3.5 and a C of about 15 ng/ml to about 35 ng/ml.
The therapeutic composition of claim 22 wherein said Cmax:Cz,999 ratio is about 15 to about 30.
The therapeutic composition of claim 22 wherein said Cmax:C ratio is about 20 to about 30.
The therapeutic composition of claim 22 wherein the active aminopyridine is 4-aminopyridine.
The therapeutic composition of claim 22 wherein the release matrix is hydroxypropylmethylcellulose.
A sustained release composition comprising:
- a sustained release matrix and an ammopyridine, wherein said composition provides a C of about 15 ng/ml to about 35 ng/ml.
Dependencies are inferred from the claim text.