Hazardous agent injection system
DCFirst Claim
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1. A hazardous agent injection system, the hazardous agent injection system comprising:
- methotrexate in an amount of from about 0.02 ml to about 4.0 ml and at a concentration of from about 7.5 mg/ml to about 150 mg/ml in a pharmaceutically acceptable solvent;
a powered injector, the powered injector comprising;
a prefilled syringe, comprising a container including a pharmaceutical solution formulation of the methotrexate and a pharmaceutically acceptable solvent;
an injection-assisting needle configured to pierce the skin of a patient and deliver methotrexate to the patient subcutaneously;
a firing mechanism associated with the prefilled syringe and configured to expel the methotrexate from the prefilled syringe through the needle for injecting the methotrexate;
an energy source associated with the firing mechanism and configured to power the firing mechanism and to inject the methotrexate from the injection outlet member; and
a trigger mechanism associated with the firing mechanism and configured to activate the firing mechanism,wherein the powered injector is configured to subcutaneously inject the methotrexate from the prefilled syringe in less than 5 seconds, such that one or more of confidence intervals of (a) the maximum concentration of methotrexate in blood plasma of a patient following administration of a dose of the methotrexate to the patient (“
Cmax”
) with the hazardous agent injection system, (b) the time to reach the maximum concentration of methotrexate in blood plasma of a patient following administration of a dose of the methotrexate to the patient with the hazardous agent injection system (“
Tmax ”
) and (c) area under the curve of the concentration of methotrexate in blood plasma of a patient following administration of a dose of the methotrexate to the patient with the hazardous agent injection system of the injected methotrexate (“
AUC”
) falls between about 80% and about 125% of a measured confidence interval of the same dose of methotrexate delivered by a hand-powered syringe.
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Abstract
Injection systems comprising a powered injector and one or more hazardous agents are disclosed.
682 Citations
20 Claims
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1. A hazardous agent injection system, the hazardous agent injection system comprising:
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methotrexate in an amount of from about 0.02 ml to about 4.0 ml and at a concentration of from about 7.5 mg/ml to about 150 mg/ml in a pharmaceutically acceptable solvent; a powered injector, the powered injector comprising; a prefilled syringe, comprising a container including a pharmaceutical solution formulation of the methotrexate and a pharmaceutically acceptable solvent; an injection-assisting needle configured to pierce the skin of a patient and deliver methotrexate to the patient subcutaneously; a firing mechanism associated with the prefilled syringe and configured to expel the methotrexate from the prefilled syringe through the needle for injecting the methotrexate; an energy source associated with the firing mechanism and configured to power the firing mechanism and to inject the methotrexate from the injection outlet member; and a trigger mechanism associated with the firing mechanism and configured to activate the firing mechanism, wherein the powered injector is configured to subcutaneously inject the methotrexate from the prefilled syringe in less than 5 seconds, such that one or more of confidence intervals of (a) the maximum concentration of methotrexate in blood plasma of a patient following administration of a dose of the methotrexate to the patient (“
Cmax”
) with the hazardous agent injection system, (b) the time to reach the maximum concentration of methotrexate in blood plasma of a patient following administration of a dose of the methotrexate to the patient with the hazardous agent injection system (“
Tmax ”
) and (c) area under the curve of the concentration of methotrexate in blood plasma of a patient following administration of a dose of the methotrexate to the patient with the hazardous agent injection system of the injected methotrexate (“
AUC”
) falls between about 80% and about 125% of a measured confidence interval of the same dose of methotrexate delivered by a hand-powered syringe. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20)
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Specification