Testosterone formulations

1. A transdermal or transmucosal formulation comprising:

2% wt of testosterone,

at least one C 2 to C 4 alkanol,

15-30% wt polyalcohol, wherein the polyalcohol is one or more of a C 2 to C 6 alkane or C 2 to C 6 alkene, substituted with two or more hydroxyl groups, and

monoalkyl ether of diethylene glycol,

wherein said formulation is substantially free of long-chain fatty alcohols, long-chain fatty acids, and long-chain fatty esters.

2. The transdermal or transmucosal formulation according to claim 1 , further comprising at least one of:

gelling agent,

neutralizing agent,

chelating agent and

solvent

or any combinations thereof.

3. The formulation of claim 2 , wherein the alkanol is present in an amount between about 5-50% wt, the permeation enhancer is present in an amount of between about 0.2-25% wt, the gelling agent is present in an amount between about 0.05-4% wt, the neutralizing agent is present in an amount between about 0.05-1% wt, and the chelating agent is present in an amount between about 0.001-5.0% wt.

4. The formulation of claim 1 , wherein the at least one alkanol is chosen from ethanol, isopropanol n-propanol, and combinations thereof.

5. The formulation of claim 1 , wherein the at least one alkanol is ethanol.

6. The formulation of claim 1 , wherein the alkanol is ethanol, present in an amount of about 44.0% wt.

7. The formulation of claim 1 , wherein the polyalcohol is propylene glycol.

8. The formulation of claim 7 , wherein the propylene glycol is present in an amount of about 20.0% wt.

9. The formulation of claim 1 , wherein the monoalkyl ether of diethylene glycol is chosen from diethylene glycol monoethyl ether, diethylene glycol monomethyl ether, and combination thereof.

10. The formulation of claim 9 , wherein diethylene glycol monoethyl ether is present in an amount of 5.0% wt.

11. The formulation of claim 2 , wherein the gelling agent is carbomer.

12. The formulation of claim 11 , wherein the carbomer is present in an amount of 1.20% wt.

13. The formulation of claim 2 , wherein the gelling agent is poly(acrylic acid), present in an amount of 1.20% wt.

14. The formulation of claim 2 , wherein the neutralizing agent is triethanolamine.

15. The formulation of claim 14 , wherein the triethanolamine is present in an amount of 0.35% wt.

16. The formulation of claim 2 , wherein the chelating agent is edetate disodium.

17. The formulation of claim 16 , wherein the edetate disodium is present in an amount of 0.06% wt.

18. The formulation of claim 2 , wherein the solvent is water.

19. A transdermal or transmucosal formulation comprising: 2% wt of testosterone, 44.0% wt of ethanol, 20.0% wt of propylene glycol, and 5.0% wt of diethylene glycol monoethyl ether, wherein said formulation is substantially free of long-chain fatty alcohols, long-chain fatty acids, and long-chain fatty esters.

20. A transdermal or transmucosal formulation comprising: 2% wt of testosterone, 44.0% wt of ethanol, 20.0% wt of propylene glycol, 5.0% wt of diethylene glycol monoethyl ether, 1.20% wt of carbomer, 0.35% wt of triethanolamine, 0.06% wt of edetate disodium and water wherein said formulation is substantially free of long-chain fatty alcohols, long-chain fatty acids, and long-chain fatty esters.

21. A transdermal or transmucosal formulation consisting of 2% wt of testosterone, 44.0% wt of ethanol, 20.0% wt of propylene glycol, 5.0% wt of diethylene glycol monoethyl ether, 1.20% wt of carbomer, 0.35% wt of triethanolamine, 0.06% wt of edetate disodium and water.

22. The formulation of claim 1 , wherein the formulation is in the form chosen from a gel, lotion, cream, spray, aerosol, ointment, emulsion, suspension, liposomal system, lacquer, patch, bandage, buccal tablet, sublingual tablet, suppository, vaginal dosage form or occlusive dressing.

23. The formulation claim 22 , wherein the form is a gel.

24. The formulation claim 1 , wherein the formulation is adapted for transdermal or transmucosal administration according to a schedule having a periodicity chosen from once to five times daily dosing, once-weekly dosing or bi-weekly dosing.

25. The formulation of claim 1 , wherein the formulation is adapted for a once daily transdermal or transmucosal administration.

26. The formulation of claim 1 , wherein the formulation is adapted for a once daily transdermal or transmucosal administration to the abdomen of a mammal in need thereof.

27. The formulation of claim 1 , wherein the formulation is adapted for a once daily transdermal or transmucosal administration to the upper arm of a mammal in need thereof.

28. A method for administering testosterone to a mammal in need thereof comprising:

transdermally administering to a skin or mucosal membrane of a mammal a formulation according to claim 1 .

29. A method of treating a disease or disorder associated with reduced endogenous testosterone production comprising:

transdermally administering to a skin or mucosal membrane of a mammal a formulation according to claim 1 .

30. The method according to claim 28 or 29 , wherein said mammal is a male.

31. A method of treating a disease or disorder associated with reduced endogenous testosterone production in a male subject comprising:

transdermally administering to a skin or mucosal membrane of a male subject a formulation comprising: 1-2% wt of testosterone, C 2 to C 4 alkanol, 20.0% wt of propylene glycol, and monoalkyl ether of diethylene glycol, wherein said formulation is substantially free of long-chain fatty alcohols, long-chain fatty acids, and long-chain fatty esters.

32. A method of treating a disease or disorder associated with reduced endogenous testosterone production in a male subject comprising:

transdermally administering to a skin or mucosal membrane of a male subject a formulation comprising: 1-2% wt of testosterone, C 2 to C 4 alkanol, 20.0% wt of propylene glycol, monoalkyl ether of diethylene glycol, gelling agent, neutralizing agent, chelating agent and solvent, wherein said formulation is substantially free of long-chain fatty alcohols, long-chain fatty acids, and long-chain fatty esters.

33. A method of treating a disease or disorder associated with reduced endogenous testosterone production in a male subject comprising:

transdermally administering to a skin or mucosal membrane of a male subject a formulation comprising 1-2% wt of testosterone, 44% wt of ethanol, 20.0% wt of propylene glycol, 5% wt of monoethyl ether of diethylene glycol, 1.20% wt of carbomer, 0.35% wt of triethanolamine, 0.06% wt of edetate disodium and water wherein the formulation is substantially free of long-chain fatty alcohols, long-chain fatty acids, and long-chain fatty esters.

34. A method of treating a disease or disorder associated with reduced endogenous testosterone production in a male subject comprising:

transdermally administering to a skin or mucosal membrane of a male subject a formulation consisting of 1-2% wt of testosterone, 44% wt of ethanol, 20.0% wt of propylene glycol, 5% wt of monoethyl ether of diethylene glycol, 1.20% wt of carbomer, 0.35% wt of triethanolamine, 0.06% wt of edetate disodium and water.

35. The method according to claim 29 , wherein the disease or disorder associated with reduced endogenous testosterone production is hypogonadism.

36. The method according to claim 29 , further comprising administering another treatment.

37. A kit comprising at least one container comprising a formulation according to claim 1 , and instructions for use thereof.

38. A kit according to claim 37 , wherein said container is adapted for dispensing a predetermined measured amount of the formulation.