Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same

1. An oral pharmaceutical composition comprising:

a. 18-22 percent by weight of solubilized testosterone undecanoate;

b. 50-55 percent by weight of at least one lipophilic surfactant; and;

c. 15-17 percent by weight of at least one hydrophilic surfactant;

d. 10-15 percent by weight of a mixture of 5-α reductase inhibitor and P450 isozyme CYP3A4 inhibitor.

2. The composition as recited in claim 1 wherein said hydrophilic surfactant is polyoxyethylene(40)hydrogenated castor oil.

3. The composition as recited in claim 1 wherein said lipophilic surfactant is oleic acid.

4. The composition as recited in claim 1 wherein said 5-α reductase inhibitor is borage seed oil.

5. The composition as recited in claim 1 wherein said P450 isozyme CYP3A4 inhibitor is peppermint oil.

6. An oral pharmaceutical composition comprising:

a. 19.8 percent by weight of solubilized testosterone undecanoate;

b. 51.6 percent by weight of oleic acid;

c. 16.1 percent by weight of polyoxyethylene(40)hydrogenated castor oil;

d. 10 percent by weight of 5-α reductase inhibitor;

e. 2.5 percent by weight of P450 isozyme CYP3A4 inhibitor; and

f. 0.03 percent by weight of butylhydroxytoluene (BHT).

7. The composition as recited in claim 6 wherein said 5-α reductase inhibitor is borage seed oil.

8. The composition as recited in claim 6 wherein said P450 isozyme CYP3A4 inhibitor is peppermint oil.

9. The composition as recited in claim 1 , wherein upon once- or twice-daily oral administration, provides an average serum testosterone concentration at steady state falling in the range of about 300 to about 1100 ng/dL.

10. The composition as recited in claim 1 , wherein the ratio of lipophilic surfactants to hydrophilic surfactants is about 4:1.

11. The composition as recited in either of claims 1 or 6 , wherein said testosterone undecanoate is dissolved in solution above 30° C.