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US 2023/0390187 A1Published application
Needle assisted jet injection administration of testosterone compositions
AssigneeAntares Pharma, Inc.
InventorsPaul K. Wotton, Kaushik J. Dave, John W. Hayes, Peter L. Sadowski, Hermanus L. Jooste, Jonathan Jaffe
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Abstract
The present invention provides compositions and methods for treating a subject in need of treatment with testosterone, including introducing testosterone into the subject subcutaneously, intradermally, or intramuscularly, from a needle assisted jet injection device.
Claims21
An injection device, comprising:
- a housing member having a distal end and a proximal end;
- a chamber disposed within the housing member configured to hold an amount of a preservative-free medicament comprising testosterone;
- a needle operatively associated with the chamber and having a length sufficient to deliver the medicament to an injection site at a depth below a patient's skin sufficient to minimize leak-back;
- a plunger movable within the chamber;
- and
- a force generating source capable of providing sufficient force on the plunger to eject at least a portion of the medicament from the chamber through the needle in less than about 20 seconds.
3 more elements
An injection device comprising:
- a housing;
- a cartridge container disposed within the housing;
- a cartridge received within the cartridge container, the cartridge having at least one opening therein and containing a medicament comprising testosterone, the medicament rearwardly confined by a plunger, wherein the cartridge includes a needle assembly to dispense the medicament there through, the needle assembly comprising a needle and a non-removable protective needle sheath, the needle having a length sufficient to deliver the medicament to an injection site at a depth below a patient's skin sufficient to minimize leak-back;
- an actuation assembly providing a stored energy source capable of being released to drive the needle through the protective needle sheath and to drive the plunger within the cartridge to dispense the medicament through the needle assembly, the stored energy source providing a force sufficient to eject at least a portion of the medicament from the chamber through the needle in less than about 20 seconds;
- a needle cover received within the housing, the needle cover having an opening formed therein to permit the passage of the needle assembly there through during a medicament dispensing operation, the needle cover having a first locked position whereby the needle cover is in a locked retracted position prior to activation of the auto-injector, the needle cover having a second locked position whereby the needle cover is in a locked extended position after operation of the auto-injector;
- a first locking assembly that holds the needle cover in the first locked position;
- and
- a second locking assembly that holds the needle cover in the second locked position.
5 more elements
-48. (canceled)
Dependencies are inferred from the claim text.