Lipocine Inc.
(17-)-3-oxoandrost-4-en-17-yl dodecanoate compositions and methods of preparation and use

Abstract:

Disclosed are bioavailable solid state (17-.beta.)-3-Oxoandrost-4-en-17-yl dodecanoate compositions and methods of use in administration to mammals in need of thereof. The (17-.beta.)-3-Oxoandrost-4-en-17-yl dodecanoate is preferably provided in a solid state crystalline form having a plurality of peaks corresponding to the peaks shown in FIG. 2, a plurality of crystallites ranging in size from about 40 nm to about 60 nm based as identified via powder x-ray diffraction spectra, and a melting point in the range of about 51.degree. C. to about 63.degree. C. The compositions may be provided in oral or injectable administration form for the treatment of conditions such as in need of testosterone therapy. An exemplary chemical structure of a (17-.beta.)-3-Oxoandrost-4-en-17-yl dodecanoate composition disclosed herein is as follows: ##STR00001##