Steroidal Compositions and Method of Making and Use

1 . An implantable pharmaceutical composition comprising:

about 90 wt % to about 99 wt % testosterone;

about 0.005 wt % to about 0.05 wt % triamcinolone; and

one or more pharmaceutically acceptable excipients.

2 . The implantable pharmaceutical composition according to claim 1 wherein the testosterone is present in an amount of about 93 wt % to about 97 wt %.

3 . The implantable pharmaceutical composition according to claim 1 wherein the triamcinolone is present in an amount of about 0.01 wt % to about 0.04 wt %.

4 . The implantable pharmaceutical composition according to claim 1 comprising about 0.5 wt % to about 9wt % of a coating agent.

5 . The implantable pharmaceutical composition according to claim 4 wherein the coating agent includes stearic acid and/or stearyl alcohol.

6 . The implantable pharmaceutical composition according to claim 1 comprising about 0.5 wt % to about 1.5 wt % of a binding agent.

7 . The implantable pharmaceutical composition according to claim 6 wherein the binding agent includes ethylcellulose.

8 . A process for preparing an implantable pharmaceutical composition comprising:

combining testosterone and triamcinolone to form an admixture;

adding a binding agent dissolved in a volatile carrier to the admixture to form wet granules;

drying the wet granules to remove the volatile carrier to form bulk granules;

milling the bulk granules to form milled granules; and

compressing the milled granules into pellets.

9 . The process according to claim 8 wherein the binding agent includes ethylcellulose.

10 . The process according to claim 8 wherein the volatile carrier includes ethanol.

11 . The process according to claim 8 comprising adding a coating agent to the milled granules prior to compressing the milled granules into the pellets.

12 . The process according to claim 11 wherein the coating agent includes stearic acid and/or stearyl alcohol.

13 . The process according to claim 8 wherein the pellets have a hardness of no more than about 75 Newtons.

14 . An implantable pharmaceutical pellet comprising testosterone and triamcinolone, wherein the implantable pharmaceutical pellet has a hardness of no more about 75 Newtons.

15 . The implantable pharmaceutical pellet according to claim 14 wherein the implantable pharmaceutical pellet comprises about 90 wt % to about 99 wt % testosterone.

16 . The implantable pharmaceutical pellet according to claim 14 wherein the implantable pharmaceutical pellet comprises about 0.005 wt % to about 0.05 wt % triamcinolone.

17 . The implantable pharmaceutical pellet according to claim 14 further comprising one or more pharmaceutically acceptable excipients.

18 . The implantable pharmaceutical pellet according to claim 17 wherein the one or more pharmaceutically acceptable excipients comprise a coating agent including stearic acid and/or stearyl alcohol.

19 . The implantable pharmaceutical pellet according to claim 14 wherein the implantable pharmaceutical pellet is configured to provide sustained release of the testosterone over a period of about four to six months.

20 . A method of treating a subject in need of testosterone therapy comprising administering to the subject an implantable pharmaceutical composition comprising about 90 wt % to about 99 wt % testosterone and about 0.005 wt % to about 0.05 wt % triamcinolone.

21 . The method of claim 20 wherein the implantable pharmaceutical composition is administered in the form of a pellet having a hardness of no more than about 75 Newtons.

22 . The method of claim 20 wherein the implantable pharmaceutical composition further comprises one or more pharmaceutically acceptable excipients.

23 . The method of claim 20 wherein the implantable pharmaceutical composition is administered subcutaneously.

24 . The method of claim 20 wherein the subject is a human male with low testosterone levels.

25 . The method of claim 20 wherein administering the pellet provides sustained release of testosterone over a period of about four to six months.