Methods of intravenous administration of glyburide and other drugs

Inventors

Jacobson, Sven Martin

Assignees

Remedy Pharmaceuticals Inc

Abstract

Methods of administering glyburide, or other drug, are disclosed. The novel methods disclosed herein include intravenous methods of administering glyburide, or other drug, over periods of more than an hour, preferably over periods of about 72 hours. The novel methods include administering a bolus of glyburide, or other drug, followed by a first continuous infusion administration of glyburide, or other drug; and optionally a second or further bolus administration of glyburide, or other drug, and/or a second or further continuous infusion administration of glyburide, or other drug. These methods are effective to rapidly achieve a desired level of glyburide, or other drug, and to provide a substantially steady level of glyburide, or other drug, over a desired period of time. The methods disclosed herein may be useful for treating a subject in need of treatment for, e.g., acute stroke (ischemic and hemorrhagic), traumatic brain injury (TBI), spinal cord injury (SCI), myocardial infarction (MI), shock (including hemorrhagic shock), organ ischemia, and ventricular arrhythmias. These methods provide for the rapid achievement and maintenance of therapeutic glyburide, or other drug, plasma levels over an extended period of time, and further avoid excessive levels of drug and so avoid possible drug side-effects.

Core Innovation

The disclosed invention relates to methods of treating acute stroke, traumatic brain injury, spinal cord injury, myocardial infarction, shock, organ ischemia, ventricular arrhythmias, ischemic injury, hypoxia/ischemia, or other injuries, conditions, and disorders. The methods administer glyburide to a subject in need of treatment to provide a substantially steady level of glyburide in the blood of the subject over a desired period of time.

In one embodiment, the administration comprises a first bolus administration of glyburide, a second bolus administration after the first bolus, followed by a first continuous infusion administration of glyburide after the second bolus administration. The bolus and infusion sequence is configured such that the resulting glyburide blood level is substantially steady over the desired period of time.

In additional embodiments, the administration comprises a bolus of glyburide followed by a first and a second continuous infusion of glyburide, where glyburide is administered at a first rate of administration for a first period of time and at a second rate of administration for a second period of time. Further embodiments include a bolus followed by first, second, and third continuous infusions, with stepped glyburide dosing by infusion rates during each continuous infusion stage, each stage occurring after the preceding bolus or infusion and contributing to maintaining a substantially steady blood level over a desired period of time.

Claims Coverage

The partial document provides three independent claims that cover stepped intravenous glyburide administration regimens to maintain a substantially steady glyburide blood level. Across the independent claims, the core claim structure is a bolus phase followed by continuous infusion phases, with multiple phases optionally included and with phase-specific infusion rates and/or bolus timing reflected in dependent claim ranges as described in the partial content.

Collectively, the independent claims cover maintaining a substantially steady glyburide blood level using intravenous administration structured as bolus dosing followed by one or more continuous infusion phases, with optional stepwise changes in infusion rate across continuous infusion stages.

Stated Advantages

Documented Applications