Testosterone transdermal spray with film

[madman]

SUMMARY

The invention provides an improved transdermal testosterone formulation. The invention relates to a sprayable liquid solution for the transdermal delivery of testosterone, and to a method of providing testosterone replacement therapy by administering this composition. The composition contains a film-forming excipient, which leaves a film on the skin. This film is washable, meaning that it can be removed with water or soap and water. This film is a barrier that prevents the transference of testosterone to others, such as the user's partner or child. In addition, the formulation provides an effective dose of testosterone in a small-volume spray that is easy to apply.

 

[madman]

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other features and aspects of the present invention can be better understood from the following description of embodiments and as illustrated in the accompanying drawings. The accompanying drawings, which are incorporated herein and form a part of the specification, further serve to illustrate the principles of the present invention.



FIG. 1 is a graph depicting the testosterone dose recovered from progressive stripped layers of skin from a tape-stripping study performed in porcine skin to compare the penetration profile of a film-forming formulation containing Eudragit® S100 to that of a non-film-forming formulation.

FIG. 2 is a graph depicting the testosterone dose recovered from progressive stripped layers of skin from a tape-stripping study performed in porcine skin to evaluate the reapplication of a dose of a film-forming formulation containing testosterone and Eudragit® S100 at the same site as a previous application of placebo film forming formulation containing Eudragit® S100.

FIG. 3 depicts an overlay of the 2DPXRD Patterns for samples taken from silicon wafer plates treated with formulations W, X2, or Y.

FIG. 4 is a graph depicting the cumulative water loss from water-filled bottles covered with a porous membrane treated with a film-forming formulation, an occluded porous membrane, or a non-occluded porous membrane.

FIG. 5 shows the permeation profiles for testosterone recovered from porcine skin samples treated with a film-forming formulation containing Eudragit® S100 with a non-film-forming formulation, AXIRON®.

FIG. 6 is a graph depicting the testosterone dose recovered from progressive stripped layers of skin from a tape stripping study performed in porcine skin to compare the penetration profile of a film-forming formulation containing Eudragit® S100 with a non-film forming formulation, AXIRON®.