Claims for Patent: 11,160,751

Summary for Patent: 11,160,751

Title:	Hematocrit modulation through needle assisted jet injection of testosterone
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.
Inventor(s):	Wotton; Paul K. (Newtown, PA), Jaffe; Jonathan (Annandale, NJ)
Assignee:	ANTARES PHARMA, INC. (Ewing, NJ)
Application Number:	15/027,387
Patent Claims:	1. A method of modulating or controlling a level of hematocrit in blood of a subject, comprising: subcutaneously administering a dose of testosterone or a pharmaceutically acceptable ester or salt thereof in sesame oil with a powered autoinj ector configured to inject the dose over an injection time of about 5 seconds to about 20 seconds such that the testosterone or the pharmaceutically acceptable ester or salt thereof in at least one of blood serum or blood plasma of the subject increases from a first concentration to a second concentration greater than the first concentration, the dose of the testosterone or the pharmaceutically acceptable ester or salt thereof comprising a concentration of about 50 milligrams per milliliter to about 400 milligrams per milliliter, wherein following administration of the dose of the testosterone or of the pharmaceutically acceptable ester or salt thereof the concentration of the testosterone or the pharmaceutically acceptable ester or salt thereof in at least one of blood serum or blood plasma of the subject, is maintained at the second concentration at a value from about 300 ng/dl to about 1800 ng/dl for a period of about 2 hours after administration to at least 5 days after administration of the dose of the testosterone or of the pharmaceutically acceptable ester or salt thereof and the level of hematocrit in the blood of the subject does not exceed 70% of a packed cell measurement volume. 2. The method of claim 1, wherein the subject has an age of about at least 60 years. 3. The method of claim 1, wherein the subject has an age of about at least 65 years. 4. The method of claim 1, wherein the subject has an age of about at least 70 years. 5. The method of claim 1, wherein the subject has an age of about at least 75 years. 6. The method of claim 1, wherein the subject has an age of from about 60 years to 75 years. 7. The method of claim 1, wherein the subject has an age of from about 60 years to 70 years. 8. The method of claim 1, wherein the subject has an age of about 75 years. 9. The method of claim 1, wherein modulating or controlling the level of hematocrit in the blood of the subject includes maintaining the level of hematocrit in the blood of the subject above a baseline level of hematocrit but below about 160% of the baseline level of hematocrit. 10. The method of claim 1, wherein the subject is a male. 11. The method of claim 1, wherein the subject is a female. 12. The method of claim 1, wherein the subject is a newborn. 13. The method of claim 1, wherein the testosterone or a pharmaceutically acceptable ester or salt thereof is administered to the subject through a subcutaneous injection using a needle-assisted jet injector. 14. The method of claim 1, wherein the level of hematocrit in the blood of the subject is maintained above a baseline hematocrit level and at or below an upper limit selected from at least one of about 110%, about 115%, about 120%, about 125%, about 130%, about 135%, about 140%, about 145%, about 150%, about 155%, and about 160% of the baseline hematocrit level. 15. The method of claim 1, wherein the dose of testosterone or pharmaceutically acceptable ester or salt thereof has a mass of about 5 mg to about 400 mg. 16. The method of claim 1, wherein the dose of testosterone or pharmaceutically acceptable ester or salt thereof is preservative free. 17. The method of claim 1, wherein the subject has a condition selected from the group consisting of hypogonadism, reduced fertility, lack of libido, erectile dysfunction, osteoporosis, and anemia. 18. The method of claim 17, further comprising treating the hypogonadism, the reduced fertility, the lack of libido, the erectile dysfunction, the osteoporosis, or the anemia in the subject. 19. The method of claim 1, wherein the concentration of the testosterone or of the pharmaceutically acceptable ester or salt thereof in at least one of blood serum or blood plasma of the subject is maintained at the second concentration for a period of about 5 days after administration to about 1 month after administration. 20. The method of claim 1, wherein the autoinjector includes a medicament chamber and the subcutaneously administering step includes activating the autoinjector such that a pressure in the medicament chamber is about 80 p.s.i. to about 1,000 p.s.i. 21. The method of claim 1, wherein the subcutaneously administering step includes injecting the dose of testosterone or a pharmaceutically acceptable ester or salt thereof such tha tleak back is less than about 6 percent of the total volume of the dose of testosterone or a pharmaceutically acceptable ester or salt thereof.