Transdermal contraceptive formulations methods and devices
AssigneeAlza Corporation
InventorsRobert M. Gale, Diane E. Nedberge, Linda E. Atkinson
Life of this patent
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Abstract
The present invention provides compositions and methods for the transdermal administration of a contraceptively effective amount of gestodene and estrogen, such as ethinyl estradiol, in combination, together with a suitable permeation enhancer. The amount of the estrogen codelivered is kept at an about constant and contraceptively effective rate while the amount of gestogen codelivered varies depending on the phase of the menstrual cycle but remains at a contraceptively effective rate. The size of the system may also vary depending on the amount of gestogeno be delivered.
Claims31
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.
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.
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.
Dependencies are inferred from the claim text.