TRANSDERMAL ESTROGEN DEVICE AND DELIVERY
First Claim
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1. A monolithic transdermal drug delivery system for estradiol, comprising a single polymer matrix layer defining an active surface area and comprising a polymer matrix comprising estradiol as the only drug, wherein the polymer matrix layer includes greater than 0.156 mg/cm2 estradiol and achieves an estradiol flux that is greater than 0.01 mg/cm2/day, based on the active surface area.
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Abstract
Described are transdermal drug delivery systems for the transdermal administration of estrogen, comprising a polymer matrix and estrogen. Methods of making and using such systems also are described.
13 Citations
20 Claims
- 1. A monolithic transdermal drug delivery system for estradiol, comprising a single polymer matrix layer defining an active surface area and comprising a polymer matrix comprising estradiol as the only drug, wherein the polymer matrix layer includes greater than 0.156 mg/cm2 estradiol and achieves an estradiol flux that is greater than 0.01 mg/cm2/day, based on the active surface area.
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10. (canceled)
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12. (canceled)
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13. A monolithic transdermal drug delivery system for estradiol comprising a single polymer matrix layer comprising estradiol as the only drug, wherein the system has an active surface area that is about 60% of a size selected from the group consisting of 2.5, 3.75, 5.0, 7.5 and 10.0 cm2 and is effective to deliver an amount of estradiol per day of about 0.025, 0.0375, 0.05, 0.075 and 0.1 mg/day, respectively.
- 14. A method for administering estradiol, comprising applying to the skin or mucosa of a subject in need thereof a monolithic transdermal drug delivery system comprising a single polymer matrix layer defining an active surface area and comprising a polymer matrix comprising estradiol as the only drug, wherein the polymer matrix includes greater than 0.156 mg/cm2 estradiol and achieves an estradiol flux that is greater than 0.01 mg/cm2/day, based on the active surface area.
- 16. A method of making a monolithic transdermal drug delivery system for administering etradiol, comprising forming a polymer matrix comprising estradiol as the only drug and a polymer blend comprising an acrylic adhesive, a silicone adhesive, and soluble PVP, and applying the polymer matrix to a support layer to form a single polymer matrix layer such that the polymer matrix layer includes greater than 0.156 mg/cm2 estradiol.
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18. (canceled)
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20. (canceled)
Specification