Needle assisted jet injection administration of testosterone compositions

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.

1 . 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 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.   
     
     
         2 . The injection device of  claim 1 , wherein the injection site is subcutaneous. 
     
     
         3 . The injection device of  claim 1 , wherein the force on the plunger is configured to eject at least a portion of the medicament from the chamber through the needle in less than about 15 seconds. 
     
     
         4 . The injection device of  claim 1 , wherein the force on the plunger is configured to eject all of the medicament from the chamber through the needle in less than about 15 seconds. 
     
     
         5 . The injection device of  claim 1 , wherein the force on the plunger is configured to eject all of the medicament from the chamber through the needle in less than about 10 seconds. 
     
     
         6 . The injection device of  claim 1 , wherein the needle length is greater than about 5 mm. 
     
     
         7 . The injection device of  claim 1 , wherein the needle length is less than about 20 mm. 
     
     
         8 . The injection device of  claim 1 , wherein the needle length is between about 5 and 12 mm. 
     
     
         9 . The injection device of  claim 1 , wherein the needle gauge is 27 gauge. 
     
     
         10 . The injection device of  claim 1 , wherein the needle gauge is 25 gauge to 30 gauge. 
     
     
         11 . The injection device of  claim 1 , wherein the needle is a thin-walled needle. 
     
     
         12 . The injection device of  claim 1 , wherein when used, there is substantially no leak-back. 
     
     
         13 . The injection device of  claim 1 , wherein when used, there is no leak-back. 
     
     
         14 . The injection device of  claim 1 , wherein when used, there is no leak-back in about 95% of the injections. 
     
     
         15 . The injection device of  claim 1 , wherein when used, the amount of leak back is less than about 15% of the total injected volume of medicament. 
     
     
         16 . The injection device of  claim 1 , wherein when used, the amount of leak back is no more than the amount of leak back selected from the group consisting of about 0.05% to about 15% of the total injected volume of medicament, about 0.1% to about 12.5% of the total injected volume of medicament, about 0.2% to about 10% of the total injected volume of medicament, about 0.3% to about 7.5% of the total injected volume of medicament, about 0.4% to about 5% of the total injected volume of medicament, about 0.5% to about 3% of the total injected volume of medicament, about 0.6% to about 2% of the total injected volume of medicament, about 0.7% to about 1% of the total injected volume of medicament. 
     
     
         17 . The injection device of  claim 1 , wherein when used, the amount of leak back is less than about 15% of the total weight of the injected medicament. 
     
     
         18 . The injection device of  claim 1 , wherein when used, the amount of leak back is no more than the amount of leak back selected from the group consisting of about 0.1% to about 15% of the total weight of the injected medicament, about 0.5% to about 12.5% of the total weight of the injected medicament, about 1% to about 10% of the total weight of the injected medicament, about 2% to about 7.5% of the total weight of the injected medicament, and about 3% to about 5% of the total weight of the injected medicament. 
     
     
         19 . The injection device of  claim 1 , further comprising a collar surrounding the needle and defining a collar cavity, the collar having a peripheral and forward skin-contacting surface that surrounds, is discontinuous, and is radially spaced from the needle and injection site by an area that is sufficiently large to allow a patient's skin to move into the collar cavity to properly position the needle to penetrate the patient for intradermal delivery of the substance to the injection site to allow spread of the injected substance under the skin while inhibiting or preventing backpressure within the skin from forcing the substance out through the injection site. 
     
     
         20 . 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.   
     
     
         21 .- 46 . (canceled) 
     
     
         47 . A therapeutic package comprising:
 a) a composition comprising a unit dose of testosterone or a pharmaceutically acceptable ester or salt thereof in a pharmaceutically acceptable carrier, at a concentration of X mg/ml such that, when the unit dose is administered to a subject by subcutaneous injection, the plasma level of testosterone is maintained between about 300 ng/dl and about 1100 ng/dl for a Z1 time period; and   b) the injection device of  claim 1 ,   
       wherein the injection device of part b) contains the unit dose of part a) prior to administration of all or part of the unit dose. 
     
     
         48 . A therapeutic package comprising:
 a) a pharmaceutical composition comprising testosterone or a pharmaceutically acceptable ester or salt thereof in a pharmaceutically acceptable carrier, at a concentration of about 50 mg/ml such that, when a unit dose of the pharmaceutical composition is administered to a subject by subcutaneous injection, the plasma level of testosterone is maintained between about 300 ng/dl and about 1100 ng/dl for a Z1 time period; and   b) the injection device of  claim 1 ,   wherein the injection device of part b) contains the pharmaceutical composition of part a) prior to administration of all or part of a unit dose of the pharmaceutical composition.   
     
     
         49 . The injection device of  claim 1 , comprising a composition comprising a unit dose of testosterone or a pharmaceutically acceptable ester or salt thereof in a pharmaceutically acceptable carrier, at a concentration of X mg/ml such that, when the unit dose is administered to a subject by subcutaneous injection, the plasma level of testosterone is maintained between about 300 ng/dl and about 1100 ng/dl for a Z1 time period. 
     
     
         50 . The injection device of  claim 1 , comprising a composition comprising a unit dose of testosterone or a pharmaceutically acceptable ester or salt thereof in a pharmaceutically acceptable carrier, at a concentration of X mg/ml such that, when the unit dose is administered to a subject by subcutaneous injection, the plasma level of testosterone is maintained at a therapeutically effective level for a Z2 time period.