Methods of intravenous administration of glyburide
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Publication Number
US-11559481-B2
Publication Date
2023-01-24
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 method fills a container with a glyburide solution having a concentration from about 2 b5g/mL to about 75 b5g/mL together with one or more selected from pharmaceutically acceptable excipients, osmoticants, diluents, buffers, and preservatives. The glyburide is stored in the container under conditions where storing does not reduce the concentration of the glyburide solution stored in the container by more than 10%, and the stored glyburide is then intravenously administered to a human subject at a rate of about 15 b5g/hr to about 300 b5g/hr.
The disclosure emphasizes maintaining glyburide exposure by rapidly achieving and sustaining therapeutic plasma glyburide concentrations while avoiding excessive exposure and hypoglycemia risk. The approach includes administering glyburide as a bolus followed by continuous infusion with multi-phase bolus/infusion regimens and rate reductions across phases.
The document further identifies administration-related handling and formulation factors intended to avoid concentration loss from contact with polyvinyl chloride (PVC) by using polyethylene (PE)-lined components and related administration handling. It also describes use of an inline filter and related measures to support preserving the glyburide solution concentration.
The disclosed regimen is positioned for acute ischemic injury and related acute clinical conditions, including acute stroke and other ischemia/hypoxia contexts, and includes specific patient conditions in which the intravenous glyburide method is carried out.
Claims Coverage
The document includes one independent claim. It defines an administration method based on glyburide-filled container formulation concentration, a storing constraint limiting concentration reduction, and a defined intravenous administration infusion-rate range; additional dependent claims refine exposure, administration duration, clinical context, and polyethylene-based administration hardware.
Container filling with defined glyburide concentration and acceptable components
Filling a container with a glyburide in a concentration of from about 2 b5g/mL to about 75 b5g/mL and one or more selected from pharmaceutically acceptable excipients, osmoticants, diluents, buffers, and preservatives.
Storing without significant concentration reduction
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%.
Intravenous administration at a defined infusion rate
Intravenously administering the glyburide stored in the container to a human subject at a rate of about 15 b5g/hr to about 300 b5g/hr.
Achieving a glyburide plasma level range
Administering glyburide to achieve a glyburide plasma level of about ng/mL to about 30 ng/mL.
Infusion rate in a narrowed quantitative subrange
Intravenously administering glyburide at a rate of about 100 b5g/hr to about 125 b5g/hr.
Prolonged intravenous administration
Administering glyburide intravenously for more than 72 hours.
Use in a human subject with specified medical conditions
Carrying out the method in a human subject having one or more specified medical conditions including stroke, spinal cord injury, brain trauma/injury, nervous system injury, myocardial infarction, ventricular arrhythmia, shock, organ ischemia, hypoxia, ischemia, or a combination thereof.
Inline filter configured with polyethylene material
Carrying out the method using an inline filter that is either polyethylene or a polyethylene-coated inline filter.
Overall claim coverage centers on preserving glyburide concentration in a container during storage, administering the preserved glyburide intravenously at a defined infusion-rate range, and refining exposure via plasma level targeting and additional dependent constraints including prolonged administration, narrowed infusion-rate subranges, specified clinical conditions, and specified polyethylene-based administration hardware.
Stated Advantages
Avoiding loss of glyburide concentration during storing by limiting concentration reduction to not more than 10%.
Reducing risk of hypoglycemia by aiming to achieve and maintain therapeutic plasma glyburide concentrations while avoiding excessive exposure.
Supporting preserved glyburide solution concentration during administration by addressing loss associated with PVC contact.
Documented Applications
Intravenous glyburide administration for acute stroke and related acute clinical conditions including traumatic brain injury (TBI), spinal cord injury (SCI), myocardial infarction (MI), shock, organ ischemia, and ventricular arrhythmias, including hypoxia/ischemia contexts.
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