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Claims for Patent: 8,663,685

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Claims for Patent: 8,663,685

Title: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.
Inventor(s): Blight; Andrew R. (Mahopac, NY), Cohen; Ron (Irvington, NY)
Assignee: Acorda Therapeutics, Inc. (Ardsley, NY)
Application Number:13/187,158
Patent Claims: 1. A method of improving walking in a human multiple sclerosis patient in need thereof comprising orally administering to said patient a sustained release composition of 10 milligrams of 4-aminopyridine twice daily for a time period of at least two weeks, wherein the sustained release composition further comprises one or more pharmaceutically acceptable excipients.

2. The method of claim 1 wherein said sustained release composition provides a mean T.sub.max in a range of about 2 to about 6 hours after administration of the sustained release composition to the patient.

3. The method of claim 2 wherein the sustained release composition is capable of providing, upon administration to the patient, a release profile of the 4-aminopyridine extending over at least 6 hours.

4. The method of claim 3 wherein the sustained release composition is capable of providing, upon administration to the patient, a release profile of the 4-aminopyridine extending over at least about 12 hours.

5. The method of claim 1 wherein the sustained release composition provides an average plasma concentration at steady state in humans in the range of about 15 ng/ml to about 35 ng/ml.

6. The method of claim 1 wherein the 4-aminopyridine is dispersed in a rate of release controlling polymer.

7. The method of claim 1 wherein the sustained release composition comprises a matrix in which the 4-aminopyridine is homogeneously dispersed that is suitable for controlling the release rate of the 4-aminopyridine.

8. The method of claim 1 wherein the step of administering comprises b.i.d. administering or administering at 12 hour intervals.
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