Claims for Patent: 8,231,906

Summary for Patent: 8,231,906

Title:	Transdermal estrogen device and delivery
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.
Inventor(s):	Mantelle; Juan (Miami, FL)
Assignee:	Noven Pharmaceuticals, Inc. (Miami, FL)
Application Number:	12/216,811
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,231,906
Patent 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 has a coat weight selected from the group consisting of 12.5 mg/cm.sup.2 and 15 mg/cm.sup.2, includes greater than 0.156 mg/cm.sup.2 estradiol, and achieves an estradiol flux that is greater than 0.01 mg/cm.sup.2/day, based on the active surface area. 2. The transdermal drug delivery system of claim 1, wherein the polymer matrix comprises a polymer blend comprising an acrylic adhesive, a silicone adhesive, and soluble polyvinylpyrrolidone (PVP). 3. The transdermal drug delivery system of claim 1, wherein the polymer matrix comprises about 2-25% by weight acrylic adhesive, about 45-70% by weight silicone adhesive, about 2-25% by weight soluble PVP, and about 5-15% penetration enhancer, all based on the total dry weight of the polymer matrix. 4. The transdermal drug delivery system of claim 3, wherein the penetration enhancer comprises oleyl alcohol. 5. The transdermal drug delivery system of claim 3, wherein the penetration enhancer comprises dipropylene glycol. 6. The transdermal drug delivery system of claim 3, wherein the penetration enhancer comprises oleyl alcohol and dipropylene glycol. 7. The transdermal drug delivery system of claim 3, wherein the acrylic adhesive and silicone adhesive are present in a ratio of from about 1:2 to about 1:6, based on the total weight of the acrylic and silicone adhesives. 8. The transdermal drug delivery system of claim 1, wherein the polymer matrix comprises an amount of estradiol effective to deliver a therapeutically effective amount of estradiol over a period of time selected from the group consisting of at least 1 day, at least 2 days, at least 3 days, at least 4 days, at least 5 days, at least 6 days and at least 7 days. 9. The transdermal drug delivery system of claim 1, wherein the polymer matrix comprises an amount of estradiol effective to deliver an amount of estradiol selected from the group consisting of about 0.025, 0.0375, 0.05, 0.075 and 0.1 mg/day. 10. A monolithic transdermal drug delivery system for estradiol comprising a single polymer matrix layer comprising estradiol as the only drug, wherein the polymer matrix layer has a coat weight selected from the group consisting of 12.5 mg/cm.sup.2 and 15 mg/cm.sup.2, and 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 cm.sup.2 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. 11. A method for administering estradiol, con 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 layer has a coat weight selected from the group consisting of 12.5 mg/cm.sup.2 and 15 mg/cm.sup.2, includes greater than 0.156 mg/cm.sup.2 estradiol, and achieves an estradiol flux that is greater than 0.01 mg/cm.sup.2/day, based on the active surface area. 12. The method of claim 11, 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 cm.sup.2 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. 13. A method of making a monolithic transdermal drug delivery system for administering estradiol, 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 has a coat weight selected from the group consisting of 12.5 mg/cm.sup.2 and 15 mg/cm.sup.2 and includes greater than 0.156 mg/cm.sup.2 estradiol. 14. The method of claim 13, 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 cm.sup.2.