Hazardous agent injection system

• US 8,480,631 B2
• Filed: 09/07/2012
• Issued: 07/09/2013
• Est. Priority Date: 03/20/2009
• Status: Active Grant

• Current Assignee: Otter Pharmaceuticals LLC (Assertio Holdings, Inc.)
• Original Assignee: Antares Pharma Incorporated
• Inventors: Wotton, Paul, Hayes, John William, Sadowsky, Peter L.
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): PENG, LAUREN MICHELE
• Application Number:
  US13/607,659
• Publication Number:
  US 20130030367A1
• Time in Patent Office: 305 Days
• Field of Search: 604134-136, 604/181, 604/187, 604/218, 604/228, 604/232
• US Class Current: 604/181
• CPC Class Codes: A61K 31/519 ortho- or peri-condensed with heterocyclic rings
• CPC Class Codes: A61K 31/568 substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61K 9/0087 Galenical forms not covered by A61K9/02 - A61K9/7023
• CPC Class Codes: A61M 2005/2013 triggering of discharging means by contact of injector with patient body
• CPC Class Codes: A61M 2005/2073 preventing premature release, e.g. by making use of a safety lock
• CPC Class Codes: A61M 2005/3247 Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
• CPC Class Codes: A61M 5/178 Syringes
• CPC Class Codes: A61M 5/2033 Spring-loaded one-shot injectors with or without automatic needle insertion multishot dosing syringes A61M5/31525, needle insertion only A61M5/3287
• CPC Class Codes: A61M 5/30 Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
• CPC Class Codes: A61M 5/3202 Devices for protection of the needle before use, e.g. caps A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001
• CPC Class Codes: A61M 5/326 Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

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_max, T_max and bioavailability of the needle-assisted jet injected methotrexate falls between about 80% and about 125% of the C_max, T_max and bioavailability of methotrexate delivered by a hand-powered syringe.

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_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_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.