DROSPIRENONE CONTAINING TRANSDERMAL DRUG DELIVERY DEVICES AND METHODS OF DELIVERY THEREOF

1 . A transdermal drug delivery device comprising: an adhesive matrix; an effective amount of drospirenone; and an oligomeric adjuvant selected from an oligolactic acid, oligolactic acid derivatives, or mixtures thereof.

2 . A transdermal drug delivery device according to claim 1 wherein the oligomeric adjuvant is a permeation enhancing adjuvant.

3 . A transdermal drug delivery device according to claim 1 and further comprising a solubilizing agent.

4 . A transdermal drug delivery device according to claim 1 and further comprising an aromatic solubilizing agent.

5 . A transdermal drug delivery device according to claim 1 and further comprising a permeation enhancer selected from the group consisting of alkyl lactates, hydroxyacids, alkyl esters of fatty acids, and mixtures thereof.

6 . A transdermal drug delivery device according to claim 5 wherein the permeation enhancer comprises methyl laurate.

7 . A transdermal drug delivery device according to claim 1 and further comprising a backing film.

8 . A transdermal drug delivery device according to claim 1 wherein the oligomeric adjuvant comprises oligolactic acid.

9 . A transdermal drug delivery device according to claim 1 wherein the amount of oligomeric adjuvant is between about 5 and 30% by weight of the total weight of adhesive, drospirenone, and oligomeric adjuvant.

10 . A transdermal drug delivery device according to claim 1 wherein the amount of drospirenone is between about 5 and 15% by weight of the total amount of adhesive, drospirenone, and oligomeric adjuvant.

11 . A transdermal drug delivery device according to claim 1 wherein drospirenone is dispersed within the adhesive matrix.

12 . A transdermal drug delivery device comprising: a backing film; and an adhesive matrix comprising: an effective amount of drospirenone; a solubilizing agent; and a permeation enhancer selected from the group consisting of alkyl lactates, carboxylic acids, alkyl esters of fatty acids, and mixtures thereof.

13 . A transdermal drug delivery device according to claim 12 wherein the solubilizing agent is an aromatic solubilizing agent.

14 . A transdermal drug delivery device according to claim 12 wherein the permeation enhancer comprises methyl laurate.

15 . A transdermal drug delivery device according to claim 3 wherein the aromatic solubilizing agent is benzyl alcohol.

16 . A transdermal drug delivery device according to claim 1 wherein drospirenone is homogenously mixed within the adhesive matrix.

17 . A transdermal drug delivery device according to claim 1 wherein the adhesive matrix is substantially free of undissolved drospirenone.

18 . A transdermal drug delivery device comprising: an adhesive matrix comprising: an effective amount of drospirenone; and a permeation enhancer; wherein the concentration of drospirenone in the matrix is above about 5% by weight of the total weight of the matrix and wherein the matrix is substantially free of undissolved drospirenone.

19 . A transdermal drug delivery device according to claim 18 wherein the amount of drospirenone is between about 5 and 15% by weight of the total weight of the matrix.

20 . A transdermal drug delivery device according to claim 18 wherein the amount of permeation enhancer is between about 5 and 30% by weight of the total of the total weight of the matrix.

21 . A transdermal drug delivery device according to claim 18 and further comprising an oligomeric adjuvant selected from an oligolactic acid, oligolactic acid derivatives, or mixtures thereof.

22 . A transdermal drug delivery device according to claim 18 and further comprising a solubilizing agent.

23 . A transdermal drug delivery device according to claim 18 and further comprising an aromatic solubilizing agent.

24 . A transdermal drug delivery device according to claim 18 wherein the permeation enhancer comprises an alkyl lactate, a carboxylic acid, or an alkyl ester of a fatty acid.

25 . A transdermal drug delivery device according to claim 24 wherein the permeation enhancer comprises methyl laurate.

26 . A transdermal drug delivery device according to claim 5 wherein the permeation enhancer comprises a hydroxy acid.

27 . A transdermal drug delivery device according to claim 26 wherein the permeation enhancer comprises an alpha-hydroxy acid.

28 . A transdermal drug delivery device according to claim 27 wherein the alpha-hydroxy acid is citric acid.

29 . A transdermal drug delivery device according to claim 5 wherein the permeation enhancer comprises benzoic acid.

30 . A transdermal drug delivery device according to claim 1 and further comprising an estrogen.

31 . A transdermal drug delivery device according to claim 30 wherein the estrogen is ethinyl estradiol.

32 . A transdermal drug delivery device according to claim 1 wherein the adhesive matrix comprises an acrylate polymer.

33 . A transdermal drug delivery device according to claim 1 wherein the device provides a sustained delivery such that the transdermal flux of drospirenone at the end of use is greater than or equal to 50% of the peak flux of drospirenone during the wear period of the device.

34 . A transdermal product comprising drospirenone and optionally an estrogen according to claim 1 .

35 . A method of transdermal delivery comprising the steps of: (a) providing a transdermal drug delivery system according to claim 1 ; (b) placing the delivery system in a delivering relationship to the skin of a mammal; and (c) delivering drug to the mammal.

36 . A method of providing contraception to a human female comprising the steps of: (a) providing a transdermal drug delivery system having a total skin-contacting surface area of no more than 25 cm<2> and comprising at least about 20 mg of dissolved drospirenone within a pressure sensitive adhesive matrix; (b) placing the delivery system in a delivering relationship to the skin of a human female; and (c) delivering an amount of about 1 to 3 mg/day of drospirenone to the female for a period of about 7 days.

37 . A method according to claim 36 wherein the pressure sensitive adhesive matrix is substantially free of undissolved drospirenone.

38 . A method according to claim 35 wherein the device comprises ethinyl estradiol and further comprises the step of delivering ethinyl estradiol in an amount of about 0.01 to 0.03 mg/day to the female for a period of about 7 days.

39 . A method according to claim 35 wherein the transdermal flux of drospirenone at the end of use is greater than or equal to 50% of the peak flux of drospirenone during the wear period of the device.

40 . A method according to claim 36 wherein steps (a) to (c) are repeated at least 3 times, so as to provide at least 21 days of active administration without interruption.

41 . A method according to claim 40 wherein a period of non-administration of at least one day follows the period of 21 days of active administration.