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 .- 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.