Methods of intravenous administration of glyburide
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Assignees
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Publication Number
US-10786445-B2
Publication Date
2020-09-29
Expiration Date
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.
Core Innovation
The invention provides a method comprising filling a container with glyburide in a concentration of from about 2 μg/mL to about 75 μg/mL and one or more selected from pharmaceutically acceptable excipients, osmoticants, diluents, buffers, and preservatives. The method includes storing the glyburide in the container without reducing the concentration of the glyburide solution stored in the container by more than 10%.
The stored glyburide solution in the container is then intravenously administered to a human subject. The disclosure describes intravenous glyburide treatment for acute ischemic/hemorrhagic stroke and other acute medical conditions, including traumatic brain injury (TBI)/spinal cord injury (SCI), myocardial infarction (MI), shock, organ ischemia, ventricular arrhythmias, ischemic injury, and hypoxia/ischemia.
The description also includes bolus plus continuous infusion regimens intended to reach and maintain therapeutic plasma glyburide levels while limiting excessive exposure and hypoglycemia. Formulation, storage, and administration measures are described as preserving glyburide concentration, including avoiding PVC contact using PVC-free polyethylene containers/tubing.
Claims Coverage
The independent claim covers preparation and storage of a glyburide solution in a specified concentration range, a storage-concentration retention requirement, and subsequent intravenous administration to a human subject. The claim family further includes features for therapeutic plasma glyburide levels, dosing amount, timing after onset of specified acute conditions, and polyethylene-based container selection.
Container-filled glyburide solution at a defined concentration with selected excipients
Filling a container with glyburide in a concentration of from about 2 μg/mL to about 75 μg/mL and one or more selected from pharmaceutically acceptable excipients, osmoticants, diluents, buffers, and preservatives.
Storage that preserves glyburide concentration
Storing the glyburide in the container without reducing the concentration of the glyburide solution stored in the container by more than 10%.
Intravenous administration of the stored glyburide to a human subject
Intravenously administering the glyburide stored in the container to a human subject.
Therapeutic glyburide plasma level target range
Intravenously administering the glyburide to achieve a glyburide plasma level of about 10 ng/mL to about 30 ng/mL.
About 3 mg/day glyburide intravenous administration
Intravenously administering about 3 mg/day glyburide to a human subject.
Administration within 12 hours after onset of specified acute medical conditions
Carrying out the administering step within 12 hours after the human subject experiences one or more specified acute medical conditions selected from stroke, spinal cord injury, brain trauma, brain injury, nervous system injury, myocardial infarction, ventricular arrhythmia, shock, organ ischemia, hypoxia, ischemia, or a combination thereof.
Polyethylene or polyethylene-coated bag container
Using a container that is either a polyethylene bag or a polyethylene-coated bag.
Overall claim coverage centers on preparing and storing a glyburide solution in a specified concentration range without more than a 10% concentration reduction, followed by intravenous administration to a human subject, with additional features specifying therapeutic plasma glyburide levels, dosing amount, a post-onset timing window for specified acute conditions, and polyethylene bag or polyethylene-coated bag selection.
Stated Advantages
Maintains the glyburide concentration during storing, with the concentration not reducing by more than 10%.
Achieves a therapeutic glyburide plasma level range of about 10 ng/mL to about 30 ng/mL.
Supports administration of glyburide within 12 hours after specified acute medical conditions.
Uses polyethylene or polyethylene-coated bags, and PVC-free polyethylene containers/tubing to preserve glyburide concentration.
Documented Applications
Intravenous glyburide treatment for acute ischemic/hemorrhagic stroke.
Intravenous glyburide treatment for traumatic brain injury (TBI)/spinal cord injury (SCI).
Intravenous glyburide treatment for myocardial infarction (MI).
Intravenous glyburide treatment for shock, including hemorrhagic shock.
Intravenous glyburide treatment for organ ischemia and ischemic injury.
Intravenous glyburide treatment for ventricular arrhythmias.
Intravenous glyburide treatment for hypoxia/ischemia.
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