Needle assisted jet injection administration of testosterone compositions

• US 10,821,072 B2
• Filed: 10/01/2018
• Issued: 11/03/2020
• Est. Priority Date: 04/06/2012
• Status: Active Grant

• Current Assignee: Antares Pharma Incorporated
• Original Assignee: Antares Pharma Incorporated
• Inventors: Wotton, Paul K., Dave, Kaushik J., Hayes, John W., Sadowski, Peter L., Jooste, Hermanus L., Jaffe, Jonathan
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): Ponton, James D
• Application Number:
  US16/149,032
• Publication Number:
  US 20190030260A1
• Time in Patent Office: 764 Days
• CPC Class Codes: A61K 31/56 Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
• 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: A61M 2005/2013 triggering of discharging means by contact of injector with patient body
• CPC Class Codes: A61M 2005/206 With automatic needle insertion
• CPC Class Codes: A61M 2005/2073 preventing premature release, e.g. by making use of a safety lock
• CPC Class Codes: A61M 2205/3613 by body heat
• CPC Class Codes: A61M 2205/364 by chemical reaction
• CPC Class Codes: A61M 2205/3673 thermo-electric, e.g. Peltier effect, thermocouples, semi-conductors
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: A61M 5/002 Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001
• 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 5/3153 by single stroke limiting means
• 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: A61M 5/425 Protruding skin to facilitate piercing, e.g. vacuum cylinders, vein immobilising means
• CPC Class Codes: A61M 5/44 having means for cooling or heating the devices or media
• CPC Class Codes: A61P 5/26 Androgens

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.

Claims

1. A method of administering testosterone comprising:

subcutaneously administering a preservative-free composition comprising a unit dose of testosterone or a pharmaceutically acceptable ester or salt thereof in a pharmaceutically acceptable carrier to a mammal,

wherein a plasma level of testosterone remains above about 200 ng/dl for a predetermined period of time after administration,

and wherein administering the preservative-free composition comprises at least one injection via a powered injector comprising a housing, a chamber disposed within the housing, the chamber configured to receive the preservative-free composition, and a needle operatively associated with the chamber.

2. The method of claim 1, wherein the at least one injection consists of two injections.

3. The method of claim 1, wherein the at least one injection consists of three injections.

4. The method of claim 1, wherein the at least one injection consists of more than three injections.

5. The method of claim 1, wherein the plasma level of testosterone remains above a value selected from the group consisting of about 300 ng/dl, about 350 ng/dl, about 400 ng/dl, about 450 ng/dl, about 500 ng/dl, about 550 ng/dl, about 600 ng/dl, about 650 ng/dl, about 700 ng/dl, about 750 ng/dl, about 800 ng/dl, about 850 ng/dl, about 900 ng/dl, about 950 ng/dl, about 1000 ng/dl, about 1050 ng/dl, and about 1100 ng/dl for the predetermined period of time.

6. The method of claim 1, wherein the predetermined period of time is at least 1 hour.

7. The method of claim 1, wherein the predetermined period of time is at least 12 hours.

8. The method of claim 1, wherein the predetermined period of time period is at least 1 day.

9. The method of claim 1, wherein the predetermined period of time is at least 6 days.

10. The method of claim 1, wherein the predetermined period of time is at least 7 days.

11. The method of claim 1, wherein the predetermined period of time is at least 9 days.

12. The method of claim 1, wherein the predetermined period of time is at least 11 days.

13. The method of claim 1, wherein the predetermined period of time is at least 13 days.

14. The method of claim 1, wherein the predetermined period of time is at least 15 days.

15. The method of claim 1, wherein the predetermined period of time is at least 20 days.

16. The method of claim 1, wherein the predetermined period of time is at least 25 days.

17. The method of claim 1, wherein the preservative-free composition comprises a liquid composition.

18. The method of claim 1, wherein the administering of the preservative-free composition includes administering a single unit dose.

19. The method of claim 1, wherein the plasma level of testosterone does not exceed about 1800 ng/dl for the predetermined period of time after administration.

20. The method of claim 1, wherein the preservative-free composition is substantially free of precipitate.