SINGLE-DOSE NEEDLE-FREE ADMINISTRATION OF ANTITHROMBOTIC MEDICATIONS

• US 20070185053A1
• Filed: 01/17/2007
• Published: 08/09/2007
• Est. Priority Date: 01/17/2006
• Status: Abandoned Application

• Current Assignee: Zogenix, Inc. (UCB SA)
• Original Assignee: Zogenix, Inc. (UCB SA)
• Inventors: Linn, Lawrence
• Application Number:
  US11/624,076
• Publication Number:
  US 20070185053A1
• Time in Patent Office: Days
• US Class Current: 514/56
• CPC Class Codes: A61K 31/727 Heparin; Heparan
• CPC Class Codes: A61M 5/178 Syringes
• 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: A61P 7/02 Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors

Abstract

An antithrombotic drug is administered by a needle-free injection device for prevention or treatment of venous thromboembolism. In an embodiment, the needle-free injection device is a pre-filled, single-use, disposable device with antithrombotic medication and labeled regarding drug, dose and time of delivery.

Claims

1. A device for delivery of an antithrombotic medicament, comprising:

a needle-free injector; and

a liquid formulation comprising a pharmaceutically acceptable, injectable carrier and a pharmaceutically active antithrombotic agent.

2. The device of claim 1, wherein the needle free injector comprises a gas-powered actuator comprising a spring, and a drive member movable through a stroke to cause a substance to be delivered by the injector.

3. The device of claim 1, wherein the active antithrombotic agent is enoxaparin.

4. The device of claim 1, characterized by being pre-filled, single use, and disposable and labeled with a characteristic chosen from, drug name, drug dose amount, day and time.

5. The device of claim 3, wherein the formulation comprises between 10 mgs/mL and 200 mgs/mL of enoxaparin.

6. The device of claim 1, wherein the formulation comprises 30 mgs or 40 mgs of enoxaparin in a liquid solution with a total volume of between 0.5 mL and 2 mL.

7. A kit comprising a plurality of needleless injector devices for delivery of an antithrombotic medication, the kit comprising:

a plurality of single use, disposable needle-free injectors, wherein each injector is loaded with a liquid formulation comprising a pharmaceutically acceptable, injectable carrier and a pharmaceutically active antithrombotic agent.

8. The kit as claimed in claim 7, wherein each needleless injector is labeled with a label chosen from drug name, drug dose amount, day and time.

9. The kit as claimed in claim 7, wherein the kit further comprises instructions for using the needleless injectors.

10. A method of treatment, comprising:

screening a patient with respect to factors relating to injection with a needle including the patient'"'"'s fear of needles and the patient'"'"'s ability to use a needle for injection;

providing to a patient which has a fear of needles or an inability to correctly use a needle injector a needle free injector device which provides for needle-free delivery of a liquid formulation comprising an antithrombotic agent; and

instructing the patient with respect to the use of the device.

11. The method of claim 10, wherein the needle free injector comprises a gas-powered actuator comprising a spring, and a drive member movable through a stroke to cause a substance to be delivered by the injector.

12. The method of claim 10, wherein the patient is provided with a plurality of single use, disposable needle-free injectors, wherein each injector is loaded with a liquid formulation comprising a pharmaceutically acceptable, injectable carrier and a pharmaceutically active antithrombotic agent.

13. The method as claimed in claim 10, wherein the patient recently had surgery.

14. The method as claimed in claim 13, wherein the surgery is chosen from hip surgery, knee replacement surgery and abdominal surgery.

15. The method as claimed in claim 12, wherein the patient is a patient suffering from clot formation.

16. The method of claim 10, wherein the patient is chosen from patients about to undergo hip or knee replacement surgery, abdominal surgery, medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness, a patient who requires treatment of an emergent acute venous thromboembolism or deep vein thrombosis while or after clot formation is occurring or has already occurred and the patient is to receive or self-administer by needle-free injection a formulation containing ORG31550 (Organon).

17. The method of claim 10, wherein the active antithrombotic agent is chosen from idraparinux, α

-NPAP [α

-N-(2-naphtalenesulfonyl)-glycyl-D-4-aminophenylalanyl-piperidine], dalteparin, nadroparin, tinzaparin, ardeparin, reviparin, fondaparinux and danaparoid.