IP Library Granted Patent US 10,786,445
Granted Patent B2
US 10,786,445 · App. 16/459,893 · Granted Sep 29, 2020

Methods of intravenous administration of glyburide

Inventor: Sven Martin Jacobson (New York, NY)
Assignee: Biogen Chesapeake LLC
A61K9/0019A61K31/17A61K31/18A61K31/64
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Quick Facts
Patent No.
US 10,786,445
App. No.
16/459,893
Granted
Sep 29, 2020
Kind
B2
Abstract

The present disclosure is drawn to a method of treating a patient in need of treatment, comprising identifying a patient in need of treatment for stroke, traumatic brain injury, spinal cord injury, myocardial infarction, shock, organ ischemia, ventricular arrhythmias, ischemic injury, or hypoxia/ischemia; administering a bolus of glyburide to the patient; and administering a continuous infusion of glyburide to the patient at from about 15 μg/hr and about 300 μg/hr, wherein the continuous infusion glyburide is administered for a period of time more than about 20 hours.

Claims (22)

1. A method comprising: filling a container with a glyburide in a concentration of from about 2 μg/mL to about 75 μg/mL, and one or more selected from the group consisting of pharmaceutically acceptable excipients, osmoticants, diluents, buffers, and preservatives;

storing the glyburide in the container, wherein said storing does not reduce the concentration of the glyburide solution stored in the container by more than 10%; and

intravenously administering the glyburide stored in the container to a human subject.

2. The method of claim 1 , further comprising attaching tubing to the container.

3. The method of claim 2 , wherein the tubing is a polyethylene tubing or a polyethylene-coated tube.

4. The medical device of claim 3 , wherein the tubing is a low sorbing polyeythylene-lined tubing.

5. The method of claim 1 , further comprising attaching an inline filter to the container.

6. The method of claim 5 , wherein the inline filter is a polyethylene inline filter or a polyethylene-coated inline filter.

7. The method of claim 1 , wherein the container is a polyethylene bag or a polyethylene-coated bag.

8. The method of claim 1 , wherein the glyburide solution comprises glyburide in a concentration of from about 2 μg/mL to about 8 μg/mL.

9. The method of claim 1 , wherein the container contains glyburide in sterile water, in saline, in a sugar solution, or a combination thereof.

10. The method of claim 1 , wherein about 3 mg/day glyburide is intravenously administered to the human subject.

11. The method of claim 1 , comprising intravenously administering glyburide to the human subject such that the human subject acheives a glyburide plasma level of about 10 ng/mL to about 30 ng/mL.

12. The method of claim 1 , wherein the human subject has stroke, a spinal cord injury, a brain trauma, a brain injury, a nervous system injury, a myocardial infarction, a ventricular arrhythmia, shock, organ ischemia, hypoxia, ischemia, or a combination thereof.

13. The method of claim 1 , wherein the administering step is performed within 12 hours of the human subject suffering stroke, a spinal cord injury, a brain trauma, a brain injury, a nervous system injury, a myocardial infarction, a ventricular arrhythmia, shock, organ ischemia, hypoxia, ischemia, or a combination thereof.

14. The method of claim 1 , wherein the human subject has suffered an ischemic stroke.

15. The method of claim 1 , wherein the human subject has suffered a hemorrhagic stroke.

16. The method of claim 1 , wherein the human subject has suffered a traumatic brain injury (TBI).

17. The method of claim 1 , wherein the human subject has hemorrhagic shock.

18. The method of claim 1 , wherein the glyburide is intravenously administered for more than 48 hours.

19. The method of claim 1 , wherein the glyburide is intravenously administered for more than 72 hours.

20. The method of claim 1 , wherein the glyburide is intravenously administered for about 96 hours.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 23, 2023
From: BIOGEN CHESAPEAKE LLC
To: REMEDY PHARMACEUTICALS, INC.
Reel/Frame 064678/0502 →
Continuity (8)
Continuation 15686989 · Aug 25, 2017
Continuation 15425874 · Feb 6, 2017
Continuation 15422358 · Feb 1, 2017
Continuation 14878232 · Oct 8, 2015
Continuation 14525992 · Oct 28, 2014
Continuation 13811037
Provisional Application 61365689 · Jul 19, 2010
Related Publication 20190328653A1 · Oct 31, 2019