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Claims for Patent: 5,152,997

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Claims for Patent: 5,152,997

Title: Method and device for transdermally administering testosterone across nonscrotal skin at therapeutically effective levels
Abstract:Testosterone is administered transdermally through nonscrotal skin in a manner that mimics in amount and profile the natural production of testosterone in young adult healthy males. The testosterone is administered to the skin from a matrix which contains testosterone at subsaturation concentration and a permeation enhancer.
Inventor(s): Ebert; Charles D. (Salt Lake City, UT), Patel; Dinesh (Murray, UT), Heiber; Werner (Salt Lake City, UT)
Assignee: Theratech, Inc. (Salt Lake City, UT)
Application Number:07/652,127
Patent Claims: 1. A device for administering testosterone transdermally across an area of unbroken nonscrotal skin at a flux from 5 to 30 .mu.g/cm.sup.2 /hr comprising:

(a) a reservoir comprising testosterone dissolved in a carrier, and a skin permeation enhancer, the amount and solubility of testosterone in the carrier defining a condition of subsaturation that causes enhanced permeation of testosterone through nonscrotal skin and wherein the combined permeation enhancement resulting from said condition of subsaturation and said permeation enhancer provide said flux; and

(b) means for maintaining the reservoir in diffusional communication with said area of unbroken nonscrotal skin.

2. The device of claim 1 wherein the flux is from 10 to 20 .mu.g/cm.sup.2 /hr.

3. The device of claim 1 wherein the carrier is a fluid.

4. The device of claim 3 wherein the carrier is ethanol and water.

5. The device of claim 4 wherein the permeation enhancer comprises glycerol monooleate and methyl laurate in combination with the ethanol.

6. The device of claim 5 wherein the ethanol constitutes 20% to 70% by volume of the reservoir, the glycerol monooleate constitutes 0.5% to 5% by volume of the reservoir and the methyl laurate constitutes 0.5% to 5% by volume of the reservoir.

7. The device of claim 1 wherein the amount of testosterone in the reservoir is 5 to 50 mg.

8. The device of claim 6 wherein the amount of testosterone in the reservoir is 10 to 20 mg.

9. The device of claim 1 wherein the concentration of testosterone in the carrier is between 10% and 80% of saturation.

10. The device of claim 8 wherein the concentration of testosterone in the carrier is between 15% and 30% of saturation.

11. The device of claim 5 wherein the reservoir contains 5% to 50% by volume glycerin.

12. The device of claim 10 wherein the reservoir contains 20% to 30% by volume glycerin.

13. The device of claim 1 wherein said area is between 5 and 40 cm.sup.2.

14. A method of providing testosterone therapy to a male human comprising placing the device of claim 1 on an area of nonscrotal skin of the human.

15. A method of providing testosterone therapy to a male human comprising placing the device of claim 5 on an area of nonscrotal skin of the human.
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