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.
Claims18
A method of administering testosterone comprising:
- administering a preservative-free composition comprising a unit dose of testosterone or a pharmaceutically acceptable ester or salt thereof in a pharmaceutically acceptable carrier subcutaneously to a mammal,
- wherein after administration, a plasma level of testosterone is maintained between about 200 ng/dl and about 1800 ng/dl for a Z1 time period,
- wherein the Z1 time period is at least 1 day, and
- wherein administering the preservative-free composition consists of an injection via a powered injector comprising a housing, a chamber disposed within the housing and configured to receive the preservative-free composition, and a needle operatively associated with the chamber.
A method of administering testosterone comprising:
- administering a preservative-free composition comprising a unit dose of testosterone or pharmaceutically acceptable ester or salt thereof in a pharmaceutically acceptable carrier subcutaneously to a mammal,
- wherein after administration the plasma level of testosterone is maintained at a therapeutically effective level for a Z2 time period,
- wherein the Z2 time period is at least 1 day, and
- wherein administering the preservative-free composition consists of a single injection via a powered injector comprising a housing, a chamber disposed within the housing and configured to receive the preservative-free composition, and a needle operatively associated with the chamber.
A method of maintaining elevated plasma levels of testosterone in a mammal in need thereof comprising administering a preservative-free composition comprising:
- a unit dose of testosterone or pharmaceutically acceptable ester or salt thereof in a pharmaceutically acceptable carrier subcutaneously to a mammal,
- wherein after administration the plasma level of testosterone is maintained at a therapeutically effective level of up to about 1800 ng/dl for a Z2 time period,
- wherein the Z2 time period is at least 1 day, and
- wherein administering the preservative-free composition consists of a single injection via a powered injector comprising a housing, a chamber disposed within the housing and configured to receive the preservative-free composition, and a needle operatively associated with the chamber.
A method of administering testosterone comprising administering a preservative-free composition comprising a unit dose of testosterone or pharmaceutically acceptable ester or salt thereof in a pharmaceutically acceptable carrier subcutaneously to a mammal, wherein after administration the plasma level of testosterone is maintained between about 700 ng/dl and about 1800 ng/dl for a Z2 time period, wherein the plasma level of testosterone is also maintained between about 300 ng/dl and about 1100 ng/dl for Z3 time period, after the plasma level of an equivalent intramuscularly administered dose drops below the plasma level of the subcutaneously administered dose at the same time point post-administration, and wherein administering the preservative-free composition consists of an injection via a powered injector comprising a housing, a chamber disposed within the housing and configured to receive the preservative-free composition, and a needle operatively associated with the chamber.
Dependencies are inferred from the claim text.