Claims
- 1. A method for the transdermal coadministration of an estrogen and gestodene through the skin from a drug formulation comprised of ethinyl estradiol and gestodene, which method comprises:
- (a) placing a transdermal delivery device on the skin of a person, the device comprising:
- (i) a reservoir comprising ethinyl estradiol, gestodene and a monoglyceride skin permeation enhancer,
- (ii) a backing on the skin-distal surface of the reservoir, and
- (iii) means for maintaining the reservoir in ethinyl estradiol-gestodene-and monoglyceride-transmitting relation with the skin,
- whereby ethinyl estradiol and gestodene are coadministered through an area of skin at contraceptively effective rates, and said monoglyceride permeation enhancer is simultaneously coadministered to the area of skin at rates which are sufficient to substantially increase the permeability of the area to at least one of said ethinyl estradiol and gestodene.
- 2. A method according to claim 1 wherein the administration rate of ethinyl estradiol is maintained at a substantially constant rate of about 30-50 .mu.g/day for a predetermined period of time while the administration rate of gestodene is varied between a first level of about 25 .mu.g/day for a predetermined period of time, a second level of about 100 .mu.g/day for a predetermined period of time, and a third level of about 50 .mu.g/day for a predetermined period of time.
- 3. A method according to claim 2 wherein the administration rate of gestodene is increased by increasing the base surface area of the transdermal drug delivery device.
- 4. A method for providing contraception to a woman comprising:
- (a) placing a transdermal delivery device on an area of the woman's skin, the device comprising:
- (i) a reservoir comprising ethinyl estradiol, gestodene and a monoglyceride skin permeation enhancer,
- (ii) a backing on the skin-distal surface of the reservoir, and
- (iii) means for maintaining the reservoir in ethinyl estradiol-gestodene-and monoglyceride-transmitting relation with the skin,
- whereby ethinyl estradiol and gestodene are coadministered through the area of skin at contraceptively effective, but not necessarily equal rates, and said monoglyceride permeation enhancer is simultaneously coadministered to the area of skin at rates which are sufficient to substantially increase the permeability of the area to at least one of said ethinyl estradiol and gestodene.
- 5. A method according to claim 4 wherein the administration rate of ethinyl estradiol is maintained at a substantially constant rate of about 30-50 .mu.g/day for a predetermined period of time while the administration rate of gestodene is varied between a first level of about 25 .mu.g/day for a predetermined period of time, a second level of about 100 .mu.g/day for a predetermined period of time, and a third level of about 50 .mu.g/day for a predetermined period of time.
- 6. A method according to claim 5 wherein the administration rate of gestodene is increased by increasing the base surface area of the transdermal drug delivery device.
- 7. A method according to claim 1 wherein the permeation enhancer is glycerol monooleate, glycerol monolinoleate or glycerol monolaurate.
- 8. A method according to claim 1 wherein the permeation enhancer is glycerol monooleate.
- 9. A method according to claim 8 wherein the ethinyl estradiol and gestodene are administered through the skin at equal rates.
- 10. A method according to claim 8 wherein the ethinyl estradiol and gestodene are administered through the skin at unequal rates.
- 11. A method according to claim 7 wherein the gestodene and ethinyl estradiol are administered through the skin at a rate of from about 30 .mu.g/day to about 50 .mu.g/day for a predetermined period of time.
- 12. A method according to claim 10 wherein the ethinyl estradiol is administered through the skin at a rate from about 30 .mu.g/day to about 50 .mu.g/day for a predetermined period of time and the gestodene is administered through the skin at a rate of about 100 .mu.g/day for a predetermined period of time.
- 13. A method according to claim 10 wherein the ethinyl estradiol is administered through the skin at a rate from about 30 .mu.g/day to about 50 .mu.g/day for a predetermined period of time and the gestodene is administered through the skin at a rate of about 25 .mu.g/day for a predetermined period of time.
- 14. A method according to claim 4, wherein the permeation enhancer is glycerol monooleate, glycerol monolinoleate or glycerol monolaurate.
- 15. A method according to claim 4 wherein the permeation enhancer is glycerol monooleate.
- 16. A method according to claim 14, wherein the ethinyl estradiol and gestodene are administered through the skin at equal rates.
- 17. A method according to claim 14 wherein the ethinyl estradiol and gestodene are administered through the skin at unequal rates.
- 18. A method according to claim 14, wherein the ethinyl estradiol and gestodene are administered through the skin at a rate from about 30 .mu.g/day to about 50 .mu.g/day for a predetermined period of time.
- 19. A method according to claim 17, wherein the ethinyl estradiol is administered through the skin at a rate from about 30 .mu.g/day to about 50 .mu.g/day for a predetermined period of time and the gestodene is administered through the skin at a rate of about 100 .mu.g/day for a predetermined period of time.
- 20. A method according to claim 17, wherein the ethinyl estradiol is administered through the skin at a rate from about 30 .mu.g/day to about 50 .mu.g/day for a predetermined period of time and the gestodene is administered through the skin at a rate of about 25 .mu.g/day for a predetermined period of time.
- 21. A device for the transdermal coadministration of an estrogen and gestodene, at a contraceptively effective, but not necessarily equal rate, from a drug formulation comprised of ethinyl estradiol and gestodene, which device comprises:
- (a) a reservoir comprising a matrix containing an amount of each of the components of the drug formulation such that each component is delivered at a contraceptively effective, but not necessarily equal rate, and a skin permeation-enhancing amount of a monoglyceride permeation enhancer;
- (b) a backing on the skin-distal surface of the reservoir; and
- (c) means for maintaining the reservoir in ethinyl estradiol-gestodene-and monoglyceride-transmitting relation with the skin.
- 22. A device according to claim 21, wherein the permeation enhancer is glycerol monooleate, glycerol monolinoleate or glycerol monolaurate.
- 23. A device according to claim 21 wherein the permeation enhancer is glycerol monooleate.
- 24. The device of claim 22 wherein the ethinyl estradiol and gestodene are administered through the skin at equal rates.
- 25. The device of claim 22 wherein the ethinyl estradiol and gestodene are administered through the skin at unequal rates.
- 26. A device according to claim 25, wherein the estradiol is administered through the skin at a rate from about 30 .mu.g/day to about 50 .mu.g/day for a predetermined period of time and the gestodene is administered through the skin at a rate of about 25 .mu.g/day for a predetermined period of time.
- 27. A method according to claim 22, wherein the ethinyl estradiol is administered through the skin at a rate from about 30 .mu.g/day to about 50 .mu.g/day for a predetermined period of time and the gestodene is administered through the skin at a rate of about 50 .mu.g/day for a predetermined period of time.
- 28. A method according to claim 25, wherein the ethinyl estradiol is administered through the skin at a rate from about 30 .mu.g/day to about 50 .mu.g/day for a predetermined period of time and the gestodene is administered through the skin at a rate of about 100 .mu.g/day for a predetermined period of time.
- 29. A device according to claim 26 having a base surface area about 3.5 cm.sup.2 in size.
- 30. A device according to claim 27 having a base surface area about 7.0 cm.sup.2 in size.
- 31. A device according to claim 28 having a base surface area about 14.0 cm.sup.2 in size.
RELATED APPLICATIONS
This is a continuation-in-part of U.S. application Ser. No. 07/994,055, filed Dec. 17, 1992, now U.S. Pat. No. 5,376,377, which was a continuation application of U.S. application Ser. No. 07/873,515, filed Apr. 20, 1992, now abandoned, which was a continuation application of U.S. Ser. No. 7/681,259, filed Apr. 8, 1991, now abandoned, which was a continuation-in-part of U.S. application Ser. No. 07/605,581, filed Oct. 29, 1990 now abandoned , which applications are incorporated herein in their entirety by reference and benefit is claimed of their filing dates.
US Referenced Citations (25)
Foreign Referenced Citations (1)
Number |
Date |
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532388 |
Oct 1988 |
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Continuations (2)
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Date |
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873515 |
Apr 1992 |
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681259 |
Apr 1991 |
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Continuation in Parts (2)
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994055 |
Dec 1992 |
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605581 |
Oct 1990 |
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