Treatment of a neuropathy with rapid release aminopyridine

• US 20050059709A1
• Filed: 07/06/2004
• Published: 03/17/2005
• Est. Priority Date: 09/15/2003
• Status: Abandoned Application

• Current Assignee: UAB Research Foundation (University of Alabama System)
• Original Assignee: UAB Research Foundation (University of Alabama System)
• Inventors: Meythaler, Jay M.
• Application Number:
  US10/885,175
• Publication Number:
  US 20050059709A1
• Time in Patent Office: Days
• US Class Current: 514/352
• CPC Class Codes: A61K 31/44 Non condensed pyridines; Hydrogenated derivatives thereof

Abstract

A process for treating neuropathy includes administration to a patient suffering from a neuropathy more than 5 and less than 18 mg of 4-aminopyridine in a dose. The 4-aminopyridine is formulated in an immediate release formulation. At least two such doses are provided per day to create spike serum plasma levels of 4-aminopyridine sufficient to drive the 4-aminopyridine across the blood-nerve barrier.

Claims

1. A process for treating neuropathy comprising the step of:

administering to a patient suffering from neuropathy more than 5 and less than 18 mg of 4-aminopyridine per dose in an immediate release formulation in at least two doses per day.

2. The process of claim 1 wherein said 4-aminopyridine is delivered in three doses per day.

3. The process of claim 1 wherein said 4-aminopyridine is delivered from 8 to 12 mg per dose.

4. The process of claim 2 wherein said 4-aminopyridine is delivered from 8 to 12 mg per dose.

5. The process of claim 1 wherein said 4-aminopyridine is delivered in conjunction with physiologically acceptable sterile aqueous or non-aqueous material selected from the group consisting of:

a carrier, a diluent, a solvent and a vehicle.

6. The process of claim 1 wherein the administration is independent of a sustained release version of 4-aminopyridine.

7. The process of claim 1 wherein administration is parenterally.

8. The process of claim 7 wherein administration is by intravenous parenteral injection.

9. The process of claim 8 wherein said intravenous parenteral injection is an intravenous push injection.

10. The process of claim 1 wherein said 4-aminopyridine is delivered in total at from 10 to 80 mg per day.

11. The process of claim 1 wherein administration is orally.

12. The process of claim 11 wherein administration is by way of a solid dosage form.

13. A process for treating neuropathy comprising the step of:

administering orally to a patient suffering neuropathy between 8 and 12 mg of 4-aminopyridine in a dose in an immediate release formulation in three doses per day.

14. The process of claim 13 wherein said 4-aminopyridine is delivered in conjunction with physiologically acceptable sterile aqueous or non-aqueous material selected from the group consisting of:

a carrier, a diluent, a solvent and a vehicle.

15. The process of claim 13 wherein the administration is independent of a sustained release version of 4-aminopyridine.

16. A process for manufacturing an immediate release version of 4-aminopyridine comprising the steps of:

mixing granulated 4-aminopyridine with a granulated inert mixing agent to form a mixture where 4-aminopyridine constitutes from 1.5 to 4.5% by weight; and

filling a capsule with said mixture.

17. The process of claim 16 wherein said 4-aminopyridine is delivered in conjunction with physiologically acceptable sterile aqueous or non-aqueous material selected from the group consisting of:

a carrier, a diluent, a solvent and an inert vehicle.

18. A capsule produced according to the process of claim 16.