|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)|
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.