Transdermal contraceptive hormones delivery
Inventors
Rossi, Thomas M. • Foegh, Marie • Kydonieus, Agis
Assignees
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Publication Number
US-9775847-B2
Publication Date
2017-10-03
Expiration Date
Abstract
Dosing regimen for transdermal delivery of hormones comprising a 28 day treatment cycle with a fixed treatment interval and a fixed rest interval.
Core Innovation
The invention relates to preventing pregnancy by transdermally administering progestin and an estrogen during a three-week treatment interval and a one-week rest interval. During the treatment interval, contraceptively effective amounts are delivered using successive weekly applications of three transdermal hormone delivery treatment interval devices, one for each week.
During the rest interval, low dose progestin and low dose estrogen are administered by application of a low dose transdermal hormone delivery device. The rest interval device delivers between 25% and 75% of the amount of progestin and between 25% and 75% of the amount of estrogen as delivered by each treatment interval device, and the woman experiences menstruation during the rest interval.
The described system includes transdermal hormone delivery devices implemented as multilayer patches with an adhesive polymer matrix and skin permeation enhancer mixtures, as well as hormone examples including levonorgestrel (LNG) and ethinyl estradiol (EE). The document characterizes rest-interval delivery as a fraction of the treatment-interval delivery and provides concentration targets and illustrative serum concentration figures for EE.
Claims Coverage
The independent claim in the provided text is directed to a transdermal method of preventing pregnancy using a three-week treatment interval and a one-week rest interval. The inventive coverage centers on successive weekly treatment-interval devices delivering progestin plus estrogen, a rest-interval device delivering low doses constituting 25% to 75% of the treatment-interval amounts, and menstruation during the rest interval.
Three-week treatment interval with successive weekly transdermal devices
During a treatment cycle having a three-week treatment interval and a one-week rest interval, transdermally administer a contraceptively effective amount of a progestin and an estrogen during the treatment interval by successive weekly applications of three transdermal hormone delivery treatment interval devices, one for each week of the treatment interval.
Rest interval low-dose device delivering 25% to 75% of treatment amounts
Transdermally administer low dose progestin and low dose estrogen throughout the rest interval by application of a low dose transdermal hormone delivery device during the rest interval, wherein the rest interval device delivers between 25% and 75% of the amount of progestin and between 25% and 75% of the amount of estrogen as delivered by each treatment interval device.
Menstruation during the rest interval
Provide that the woman experiences menstruation during the rest interval.
Specific estrogen and progestin selections for the regimen
Use an estrogen selected from one or more of the listed estradiol esters, ethinyl estradiol, and estrone, and use a progestin selected from one or more of the listed progestins.
The core inventive elements are a three-week treatment interval delivered by successive weekly transdermal progestin-plus-estrogen devices, followed by a one-week rest interval delivered via a low-dose transdermal device delivering 25% to 75% of the treatment-interval progestin and estrogen amounts, resulting in menstruation during the rest interval.
Stated Advantages
Menstruation during the rest interval.
Documented Applications
A method of preventing pregnancy in a woman using transdermal hormone delivery devices over a three-week treatment interval followed by a one-week rest interval.
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