Testosterone transdermal spray with film

madman

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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.
 

Attachments

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.
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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.
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FIG. 3 depicts an overlay of the 2DPXRD Patterns for samples taken from silicon wafer plates treated with formulations W, X2, or Y.
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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.
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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®.
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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®.
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This tool provides predictions based on statistical models and should NOT replace professional medical advice. Always consult with your healthcare provider before making any changes to your TRT protocol.

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Understanding Your Hormones

Estradiol (E2)

A form of estrogen produced from testosterone. Important for bone health, mood, and libido. Too high can cause side effects; too low can affect well-being.

DHT

Dihydrotestosterone is a potent androgen derived from testosterone. Affects hair growth, prostate health, and masculinization effects.

Free Testosterone

The biologically active form of testosterone not bound to proteins. Directly available for cellular uptake and biological effects.

Scientific Reference

Lakshman KM, Kaplan B, Travison TG, Basaria S, Knapp PE, Singh AB, LaValley MP, Mazer NA, Bhasin S. The effects of injected testosterone dose and age on the conversion of testosterone to estradiol and dihydrotestosterone in young and older men. J Clin Endocrinol Metab. 2010 Aug;95(8):3955-64.

DOI: 10.1210/jc.2010-0102 | PMID: 20534765 | PMCID: PMC2913038

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