TRANSDERMAL HORMONE DELIVERY SYSTEM: COMPOSITIONS AND MTEHODS

摘要

A transdermal hormone delivery system (THDS) is disclosed. The THDS is useful for control of fertility and as therapy for a variety of diseases and conditions treatable by robust delivery of progestin and estrogen hormones, particularly the progestin, levonorgestrel. The THDS comprises a backing layer, an adjoining adhesive polymer matrix comprising an effective amount of at least a progestin hormone, delivery of which is enhanced by one or more skin permeation enhancing agents present in pre-determined amounts. The THDS is capable of providing effective daily doses of progestin and estrogen hormones from a small surface area in contact with the skin, e.g., less than 20 square centimeters. Methods of fertility control and various types of hormone replacement therapy utilizing the THDS are also disclosed.

主权项

1. A method of controlling fertility in a female, comprising applying to the skin of the female a transdermal hormone delivery device comprising a backing layer and an adhesive polymer matrix affixed to the backing layer, the adhesive polymer matrix comprising levonorgestrel and ethinyl estradiol, wherein application of the device to the skin of a female for one or more one-week dosing periods results in an in vivo serum concentration profile of levonorgestrel in which a maximum concentration is reached by or before about midway through the dosing period and thereafter declines to the end of the dosing period, and an average serum concentration of at least about 1,000 pg/ml levonorgestrel is achieved for the dosing period, wherein the device is applied to the skin in a four-week regimen comprising application of one device once each week for three consecutive weeks, followed by one week in which the device optionally is not applied, thereby controlling fertility in the female.