Claims for Patent: 8,480,631

Summary for Patent: 8,480,631

Title:	Hazardous agent injection system
Abstract:	A hazardous agent injection system including from about 0.02 ml to about 4.0 ml of methotrexate at a concentration of from about 7.5 mg/ml to about 150 mg/ml; a needle-assisted jet injector including a container configured to contain the methotrexate; a injection outlet member associated with the container; an injection-assisting needle coupled to the injection outlet member; a firing mechanism associated with the container; an energy source associated with the firing mechanism; and a trigger mechanism associated with the firing mechanism, wherein the needle-assisted jet injector is configured to eject the methotrexate from the injection outlet member such that the C.sub.max, T.sub.max and bioavailability of the needle-assisted jet injected methotrexate falls between about 80% and about 125% of the C.sub.max, T.sub.max and bioavailability of methotrexate delivered by a hand-powered syringe.
Inventor(s):	Wotton; Paul (Stamford, CT), Sadowsky; Peter L. (Woodbury, MN), Hayes; John William (Chaska, MN)
Assignee:	Antares Pharma, Inc. (Ewing, NJ)
Application Number:	13/607,659
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,480,631
Patent Claims:	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; a needle-assisted jet injector, the needle-assisted jet injector comprising: a container configured to contain the methotrexate; an injection outlet member associated with the container, the injection outlet member including an injection-assisting needle configured to pierce the skin of a patient and deliver a jet of methotrexate to the patient subcutaneously; a firing mechanism associated with the container and configured to expel the methotrexate from the container through the outlet member for injecting the methotrexate; an energy source associated with the firing mechanism and configured to power the firing mechanism and to jet inject the methotrexate from the injection outlet member as a fluid jet; and a trigger mechanism associated with the firing mechanism and configured to activate the firing mechanism, wherein the needle-assisted jet injector is configured to eject the methotrexate from the injection outlet member 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 ("C.sub.max") 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 ("T.sub.max") 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 needle-assisted jet injected methotrexate ("AUC"} falls between about 80% and about 125% of a corresponding measured confidence interval of the same dose of methotrexate delivered subcutaneously or intramuscularly by a hand-powered syringe, and wherein the needle-assisted jet injector is configured to subcutaneously inject the methotrexate in less than 5 seconds. 2. The hazardous agent injection system of claim 1, wherein the gauge of the injection-assisting needle is selected from 26 gauge and a higher gauge number. 3. The hazardous agent injection system of claim 1, wherein the needle-assisted jet injector is configured to inject the methotrexate such that the methotrexate is needle-assisted jet injected at a flow rate of at least about 0.5 ml/sec. 4. The hazardous agent injection system of claim 1, wherein the energy source comprises a spring. 5. The hazardous agent injection system of claim 1, wherein the energy source is configured for generating a pressure of at least about 80 p.s.i. in the container. 6. The hazardous agent injection system of claim 1, wherein the needle-assisted jet injector further comprises an outer housing member configured for allowing a user to handle the injector. 7. The hazardous agent injection system of claim 6, the needle-assisted jet injector further comprises a safety member located at the proximal end of the outer housing. 8. The hazardous agent injection system of claim 7, wherein the safety member is removably affixed to the proximal end of the outer housing. 9. The hazardous agent injection system of claim 8, wherein the safety member is removably affixed to the proximal end of the outer housing by a plurality of tabs that extend through matching openings formed in the outer housing to form a press-fit between the safety member and the outer housing. 10. The hazardous agent injection system of claim 1, wherein the container and the injection outlet member associated with the container comprise a syringe. 11. The hazardous agent injection system of claim 10, wherein the needle-assisted injector further comprises a syringe sleeve, the syringe sleeve having bore portion configured to abut the outside of the syringe wall so as to minimize syringe movement resulting from of the firing mechanism action. 12. A method of treating a patient having an autoimmune disease, the method comprising administering methotrexate to the patient using the hazardous agent injection system of claim 1. 13. The method of claim 12, wherein the autoimmune disease is selected from the group consisting of rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, steroid-resistant polymyositis or dermatomyositis, Wegener's granulomatosis, polyarteritis nodosa, and vasculitis.