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Claims for Patent: 8,071,075

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Claims for Patent: 8,071,075

Title:Dermal penetration enhancers and drug delivery systems involving the same
Abstract: The invention relates to a method for treatment or prophylaxis of a disease or condition in an animal comprising administering to a mucosal membrane of said animal in need of such treatment a therapeutically effective amount of a drug delivery system comprising at least one physiologically active agent or prodrug thereof and at least one penetration enhancer selected from safe ester sunscreens.
Inventor(s): Reed; Barry Leonard (Strathmore, AU), Morgan; Timothy Matthias (Parkville, AU), Finnin; Barrie Charles (Glen Iris, AU)
Assignee: Acrux DDS Pty Ltd. (West Melbourne, Victoria, AU)
Application Number:11/905,926
Patent Claims: 1. A transdermal drug delivery system comprising: (a) a therapeutically effective amount of testosterone; (b) at least one dermal penetration enhancer present in an amount of from 10 to 10,000 wt % based on the weight of the testosterone; wherein the dermal penetration enhancer is at least one ester of formula (I): ##STR00002## wherein R.sup.1 is hydrogen, lower alkyl, lower alkoxy, halide, hydroxy or NR.sup.3R.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 or 2, wherein, when n is 0 and R.sup.1 is NR.sup.3R.sup.4, then NR.sup.3R.sup.4 is para-substituted; and (c) at least one volatile liquid present in an amount to act as a vehicle for the testosterone and penetration enhancer.

2. A drug delivery system according to claim 1, wherein said ester is a C.sub.8 to C.sub.18 alkyl para-aminobenzoate, C.sub.8 to C.sub.18 alkyl dimethyl-para-aminobenzoate, C.sub.8 to C.sub.18 alkyl cinnamate, C.sub.8 to C.sub.18 alkyl methoxycinnamate or C.sub.8 to C.sub.18 alkyl salicylate.

3. A drug delivery system according to claim 2, wherein said ester is octyl dimethyl-para-aminobenzoate, octyl para-methoxycinnamate or octyl salicylate.

4. A drug delivery system according to claim 1, wherein the drug delivery system is not supersaturated with respect to the testosterone.

5. A method for the treatment of a testosterone deficient hypogonadal man which comprises administering to a dermal surface of said man in need of such treatment a therapeutically effective amount of the drug delivery system according to claim 1.

6. The transdermal drug delivery system according to claim 3, wherein said ester is octyl salicylate.

7. The transdermal drug delivery system according to claim 3, wherein said volatile liquid is selected from the group consisting of ethanol, isopropanol, and a mixture thereof.

8. The drug delivery system according to claim 6, wherein said volatile liquid is selected from the group consisting of ethanol, isopropanol, and a mixture thereof.

9. The method according to claim 5, wherein said ester is a C.sub.8 to C.sub.18 alkyl para-aminobenzoate, C.sub.8 to C.sub.18 alkyl dimethyl-para-aminobenzoate, C.sub.8 to C.sub.18 alkyl cinnamate, C.sub.8 to C.sub.18 alkyl methoxycinnamate or C.sub.8 to C.sub.18 alkyl salicylate.

10. The method according to claim 9, wherein said ester is octyl dimethyl-para-aminobenzoate, octyl para-methoxycinnamate, or octyl salicylate.

11. The method according to claim 10, wherein said ester is octyl salicylate.

12. The method according to claim 10, wherein said volatile liquid is selected from the group consisting of ethanol, isopropanol, and a mixture thereof.

13. The method according to claim 11, wherein said volatile liquid is selected from the group consisting of ethanol, isopropanol, and a mixture thereof.
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