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Details for Patent: 6,998,138

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Details for Patent: 6,998,138

Title:Topical delivery of anti-alopecia agents
Abstract: The present invention provides a topical drug delivery system which comprises: a therapeutically effective amount of an anti-alopecia agent; at least one dermal penetration enhancer, which is a safe skin-tolerant ester sunscreen ester; and a volatile liquid. The invention also provides a method for administering at least one systemic acting anti-alopecia agent to an animal which comprises applying an effective amount of the anti-alopecia agent in the form of the drug delivery system of the present invention.
Inventor(s): Chew; Nora Yat Knork (Melbourne, AU), Reed; Barry Leonard (Strathmore, AU), Morgan; Timothy Matthias (Carlton North, AU), Finnin; Barrie Charles (Glen Iris, AU)
Assignee: Acrux DDS Pty. Ltd. (Victoria, AU)
Filing Date:Aug 08, 2003
Application Number:10/636,976
Claims:1. A transdermal drug delivery system which comprises: a. a therapeutically effective amount of an anti-alopecia agent; b. at least one dermal penetration enhancer, which is a safe skin-tolerant ester sunscreen of formula (I): ##STR00002## wherein R.sup.1 is hydrogen, lower alkyl, lower alkoxy, halide, hydroxy or NR.sup.3 R.sup.4, R.sup.2 is a C.sub.8 to C.sub.18 alkyl, R.sup.3 and R.sup.4 are each independently hydrogen, lower alkyl or R.sup.3 and R.sup.4 together with the nitrogen atom to which they are attached form a 5- or 6-membered heterocyclic ring; n is 0 or 1, and q is 1 or2, wherein when n is 0 and R.sup.1 is NR.sup.3 R.sup.4, then NR.sup.3 R.sup.4 is para-substituted; and wherein said dermal penetration enhancer is present in an amount of from about 10 to about 10,000 wt % based on the weight of the anti-alopecia agent; and c. a volatile liquid.

2. A transdermal drug delivery system according to claim 1, wherein the dermal penetration enhancer is octyl salicylate.

3. A transdermal drug delivery system according to claim 2, wherein the anti-alopecia agent is selected from the list consisting of minoxidil, cromakalin, pinacidil, naminidil, diphenylcyclopropenone, cyproterone acetate, danazol, tricomin, turosteride, LY-191704, MK-306, dutasteride and those compounds selected from the classes of s-triazines, benzopyran, pyridinopyran and thiane-1-oxides or pharmaceutically acceptable salts or derivatives of any one of the aforementioned.

4. A transdermal drug delivery system according to claim 2, wherein the anti-alopecia agent is a 5-alpha reductase inhibitor.

5. A transdermal drug delivery system according to claim 4, wherein the 5-alpha reductase inhibitor is finasteride.

6. A transdermal drug delivery system according to claim 2, wherein the anti-alopecia agent is an antiandrogen.

7. A transdermal drug delivery system according to claim 6, wherein the antiandrogen is flutamide.

8. A transdermal drug delivery system according to claim 1, wherein the volatile liquid is ethanol, isopropanol or mixture thereof.

9. A transdermal drug delivery system according to claim 8 comprising on a weight basis: a. from about 0.1 to about 10% of the anti-alopecia agent; b. from about 1 to 10% of the dermal penetration enhancer; and c. from about 45 to 99.8% ethanol, isopropanol or mixture thereof.

10. A transdermal drug delivery system according to claim 8 comprising on a weight basis: a. from about 0.1 to about 6% of the anti-alopecia agent; b. from about 1 to 10% of the dermal penetration enhancer; and c. from about 80 to 98% ethanol, isopropanol or mixture thereof.

11. A transdermal drug delivery system according to claim 8 which comprises on a weight basis: a. 0.1 to 6% finasteride; b. from about 1 to 10% octyl salicylate; and c. from about 80 to 98% Alcohol USP (95% ethanol).

12. A transdermal drug delivery system according to claim 8 which comprises on a weight basis: a. 0.1 to 5% finasteride; b. from about 1 to 5% octyl salicylate; and c. from about 45 to 90% ethanol, isopropanol or mixture thereof; d. 5 to 45% water; and e. 0.5 to 5% of a thickening agent.

13. A method for administering at least one systemic acting anti-alopecia agent to an animal which comprises applying an effective amount of the anti-alopecia agent in the form of a drug delivery system according to claim 1.

14. A method according to claim 13, wherein the anti-alopecia agent is finasteride.

15. A method according to claim 14, wherein the drug delivery system is applied to the skin of the human or animal covering a delivery surface area between 10 and 800 cm.sup.2.

16. A method according to claim 14, wherein the drug delivery system is applied to the skin of the human or animal covering a delivery surface area between 10 and 400 cm.sup.2.

17. A method according to claim 14, wherein the drug delivery system is applied to the skin of the human or animal covering a delivery surface area between 10 and 200 cm.sup.2.

18. A method according to claim 14, wherein the drug delivery system is applied using a fixed or variable metered dose applicator.
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