Oral pharmaceutical products and methods of use combining testosterone esters with hypolipidemic agents

Abstract

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.

What is claimed is: 
     
         1 .- 66 . (canceled) 
     
     
         67 . A pharmaceutical product comprising one or more pharmaceutical compositions, wherein said one or more pharmaceutical compositions comprise:
 a. peroxisome proliferator activating receptor (PPAR) agonist; and   b. testosterone undecanoate solubilized in a carrier comprising at least one lipophilic surfactant and at least one hydrophilic surfactant;   wherein the total lipophilic surfactant to total hydrophilic surfactant ratio (w/w) in said carrier falls in the range of about 6:1 to 3.5:1   
     
     
         68 . The pharmaceutical product of  claim 67 , wherein said PPAR agonist is a pan-PPAR agonist. 
     
     
         69 . The pharmaceutical product of  claim 67 , wherein said PPAR agonist is a selective PPARδ agonist. 
     
     
         70 . The pharmaceutical product of  claim 67 , wherein said PPAR agonist is a selective PPARα agonist. 
     
     
         71 . The pharmaceutical product of  claim 70 , wherein said selective PPARα agonist is selected from: bezafibrate, ciprofibrate, clofibrate, fenofibrate, and gemfibrozil. 
     
     
         72 . The pharmaceutical product of  claim 67 , wherein the at least one lipophilic surfactant is a C 6 -C 24  fatty acid, saturated, unsaturated and mixtures thereof. 
     
     
         73 . The pharmaceutical product of  claim 67 , wherein the at least one lipophilic surfactant is a C 8 -C 18  fatty acid, saturated, unsaturated and mixtures thereof. 
     
     
         74 . The pharmaceutical product of  claim 73 , wherein the at least one lipophilic surfactant comprises oleic acid. 
     
     
         75 . The pharmaceutical product of  claim 67 , wherein the at least one lipophilic surfactant is a mono- and/or diglycerides of C 8 -C 20  fatty acids, saturated, unsaturated and mixtures thereof. 
     
     
         76 . The pharmaceutical product of  claim 75 , wherein the mono- and/or diglycerides of C 8 -C 20  fatty acids are chosen from Capmul® MCM (glyceryl mono-di-caprylate/caprate), Precirol™ ATOS (glyceryl palmitostearate), Peceol™ (glyceryl monooleate) and Maisine™ (glyceryl monolinoleate). 
     
     
         77 . The pharmaceutical composition of  claim 67  may further comprise of mono-, di- or polyhydric alcohol. 
     
     
         78 . The pharmaceutical product of  claim 77  wherein said polyhydric alcohol is polyethylene glycol with an average molecular weight of about 200 to about 10,000 g/mol. 
     
     
         79 . The pharmaceutical product of  claim 67 , wherein said hydrophilic surfactant comprises Cremophor® RH40.