Oral pharmaceutical products and methods of use combining testosterone esters with hypolipidemic agents
Pharmaceutical products comprising a hypolipidemic agent and a testosterone ester such as testosterone undecanoate are provided. Methods of safely treating a testosterone deficiency or its symptoms with the inventive pharmaceutical products are also provided.
1. A oral pharmaceutical composition comprising:
a. a hypolipidemic agent that is a peroxisome proliferator activating receptor (PPAR) agonist; and
b. 18 to 22 percent by weight of solubilized testosterone undecanoate, solubilized in a carrier comprising
i. 15 to 17 percent by weight of hydrophilic surfactant;
ii. 50 to 55 percent by weight of lipophilic surfactant; and
iii. 10-15 percent by weight of a mixture of borage oil and peppermint oil.
2. The pharmaceutical product of claim 1 , wherein said PPAR agonist is a pan-PPAR agonist.
3. The pharmaceutical product of claim 1 , wherein said PPAR agonist is a selective PPARδ agonist.
4. The pharmaceutical product of claim 1 , wherein said PPAR agonist is a selective PPARα agonist.
5. The pharmaceutical product of claim 4 , wherein said selective PPARα agonist is selected from: bezafibrate, ciprofibrate, clofibrate, fenofibrate, and gemfibrozil.
6. The pharmaceutical product of claim 1 , wherein said hypolipidemic agent and said testosterone ester are combined in the same pharmaceutical composition.
7. The pharmaceutical product of claim 6 wherein said pharmaceutical composition is a liquid- or semi-solid filled capsule, a powder-filled capsule, or a tablet.
8. A method of treating testosterone deficiency or its symptoms comprising orally administering to an individual suffering from testosterone deficiency or its symptoms an effective amount of a pharmaceutical product of claim 1 .
9. The method of claim 8 in which said one or more pharmaceutical compositions are administered once daily.
10. The method of claim 8 in which said one or more pharmaceutical compositions are administered twice daily.
11. The method of claim 8 which gives rise to a testosterone C max value in said individual falling in the range of about 900 to 1100 ng/dL.