Transdermal estrogen/progestin dosage unit, system and process

Details Transdermal estrogen/progestin dosage unit, system and process Transdermal estrogen/progestin dosage unit, system and process

A - Human Necessities

61

K

167/194

A61K 31/565 (2006.01) A61K 9/70 (2006.01)

Patent

CA 1313623

ABSTRACT TRANSDERMAL ESTROGEN/PROGESTIN DOSAGE UNIT, SYSTEM AND PROCESS Transdermal estrogen/progestin absorption dosage units have been developed which comprise a backing layer, an adjoining polymer layer is an adhesive layer in which at least minimum effective dose of an estrogen is dissolved or microdispersed. Adhered to the polymer layer is an adhesive layer in which is dissolved and/or microdispersed at least minimum doses of progestin. Presently preferred is use of the natural estrogen, 17-beta-estradiol, or ethinyl estra- diol or combinations thereof and of the progestin, norethin- drone or norgestimate or combinations thereof. The units have biologically acceptable adhesive and polymer layers. The adhesive layer can have dispersed one or more skin permeation enhancing agents. A separating layer can option- ally be used in making the dosage units, which separate space the adhesive and polymer layers, which permits estro- gen transmission from the polymer layer during treatment. Dosage units are provided which transdermally deliver at least minimum daily doses of the estrogen and progestin for multiple days, such as for one week. The invention also provides a process of fertility control and estrogen replacement therapy using the novel dosage units. Also, the invention provides a fertility control system for fertility control using the novel dosage units.

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