Transdermal contraceptive formulations
AssigneeAlza Corporation
InventorsDiane E. Nedberge, Patricia S. Campbell, Robert M. Gale, Su I. Yum
Life of this patent
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Abstract
A transdermal delivery system for the administering of ethinyl estradiol and levonorgestrel, in combination, utilizing a polymer matrix having the drug formulation along with a permeation enhancer dispersed throughout.
Claims26
A composition of matter for the transdermal administration of a drug formulation comprised of ethinyl estradiol and levonorgestrel, comprising a matrix containing said drug formulation and a skin permeation enhancing amount of glycerol monooleate.
A transdermal therapeutic system comprising a reservoir containing a drug formulation comprised of ethinyl estradiol and levonorgestrel, and a skin permeation enhancing amount of glycerol monooleate, in combination with:
- an occlusive backing behind the skin distal surface of said reservoir composition;
- and
- means for maintaining said reservoir composition in drug formulation and glycerol monooleate transferring relationship to human skin.
A method for the transdermal administration of a drug formulation comprised of ethinyl estradiol and levonorgestrel, which comprises placing said drug formulation in drug transmitting relationship to the skin in the presence of a drug permeation enhancing amount of glycerol monooleate.
A medical device for the transdermal delivery of a drug formulation comprised of ethinyl estradiol and levonorgestrel, comprising in combination:
- a reservoir means containing a skin permeable formulation containing said drug formulation;
- an occlusive backing behind the skin distal surface of said reservoir means and extending beyond the periphery of said reservoir means;
- and
- an adhesive overlay disposed on the skin distal surface of said occlusive backing and extending beyond the periphery thereof.
A medical device for the transdermal administration of a drug formulation comprised of ethinyl estradiol and levonorgestrel through intact skin for an extended period of time at a therapeutic rate of at least 15 .mu.g/day of ethinyl estradiol and at least 50 .mu.g/day of levonorgestrel, which comprises:
- a unit activity reservoir of a skin permeable form of said formulation, said reservoir comprising a carrier having said formulation substantially uniformly distributed there through at a concentration above saturation;
- a reservoir of a skin permeation enhancer for said material;
- and
- means for maintaining said formulation reservoir and said permeation enhancer reservoir in formulation and permeation enhancer transferring relationship to the same area of intact skin.
A method for the transdermal delivery of a drug formulation comprised of ethinyl estradiol and levonorgestrel at a therapeutic rate of at least 15 .mu.g/day of ethinyl estradiol and at least 50 .mu.g/day of levonorgestrel, for an extended period of time, which comprises:
- contacting an area of intact skin with a source of a skin permeable form of said formulation at unit activity and a skin permeation enhancer for said formulation at a permeation enhancing concentration;
- maintaining said source in formulation and permeation enhancer transmitting contact with the skin for said extended period of time;
- and
- maintaining the source of said formulation at unit activity and said permeation enhancer at a permeation enhancing concentration for said extended period of time.
A method for producing a contraceptive effect in the human female which comprises transdermally co-administering ethinyl estradiol and levonorgestrel at contraceptively effective rates and maintaining said co-administration continuously throughout the period for which contraception is required.
Dependencies are inferred from the claim text.