EP3797762A1 — Lipobalanced long chain testosterone esters for oral delivery

USPTO Abstract

The present disclosure is drawn to oral pharmaceutical compositions and dosage forms containing select testosterone esters and related methods. In one embodiment of the present invention, an oral pharmaceutical composition for administration to subjects in need of testosterone is provided. The composition comprises a testosterone ester and a pharmaceutically acceptable carrier. The testosterone ester can have the structure wherein R is -C<sub>13</sub>H<sub>25</sub>O or-C<sub>14</sub>H<sub>27</sub>O. One or both of the esters can be present in the pharmaceutical composition. The composition is formulated such that upon single dose administration to a group of human subject, the composition provides a mean serum testosterone C<sub>avg t12-t24</sub> that is within about 35% to about 70% of the mean serum testosterone C<sub>avg t0-t24</sub>.