Sustained release aminopyridine composition
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.
1. A method of increasing walking speed 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 a single administration of said sustained release composition of 10 milligrams of 4-aminopyridine to a human provides a maximum observed plasma concentration of 4-aminopyridine in a range of 27.7±9.1 ng/mL.
2. The method of claim 1 , wherein said time period comprises 12 weeks.
3. The method of claim 1 , wherein said sustained release composition provides a mean T max in a range of about 2 to about 5.2 hours after administration of the composition to the patient.
4. The method of claim 1 , wherein said sustained release composition of 10 milligrams of 4-aminopyridine is administered without a prior period of 4-aminopyridine titration, and without a subsequent period of 4-aminopyridine titration.
5. The method of claim 1 , wherein the twice daily administering is administering at 12-hour intervals.
6. The method of claim 1 , wherein said sustained release composition is a tablet.
7. A method of increasing walking speed 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 twice daily administration of said sustained release composition of 10 milligrams of 4-aminopyridine to a human provides a maximum observed plasma concentration of 4-aminopyridine at steady state in a range of 32.2±8.9 ng/mL.
8. The method of claim 7 , wherein said time period comprises 12 weeks.
9. The method of claim 7 , wherein said sustained release composition provides a mean T max in a range of about 2 to about 5.2 hours after administration of the composition to the patient.
10. The method of claim 7 , wherein said sustained release composition of 10 milligrams of 4-aminopyridine is administered without a prior period of 4-aminopyridine titration, and without a subsequent period of 4-aminopyridine titration.
11. The method of claim 7 , wherein the twice daily administering is administering at 12-hour intervals.
12. The method of claim 7 , wherein said sustained release composition is a tablet.