Claims for Patent: 9,730,900

Summary for Patent: 9,730,900

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:	13/553,972
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,730,900
Patent Claims:	1. A method for administering estradiol, comprising applying to the skin or mucosa of a subject in need thereof a monolithic transdermal drug delivery system consisting of (i) a backing layer and (ii) a single adhesive polymer matrix layer defining an active surface area and comprising an adhesive polymer matrix comprising estradiol as the only drug, wherein the polymer matrix has a coat weight of greater than about 10 mg/cm.sup.2 and includes greater than 0.156 mg/cm.sup.2 estradiol, and the system achieves an estradiol flux of from about 0.0125 to about 0.05 mg/cm.sup.2/day, based on the active surface area. 2. The method of claim 1, wherein the adhesive polymer matrix comprises a polymer blend comprising an acrylic adhesive, a silicone adhesive, and soluble polyvinylpyrrolidone (PVP). 3. The method of claim 1, wherein the adhesive polymer matrix comprises about 2-25% by weight acrylic adhesive, about 45-70% by weight silicone adhesive, about 2-25% by weight soluble PVP, about 5-15% penetration enhancer, and about 0.1-10% by weight estradiol, all based on the total dry weight of the adhesive polymer matrix. 4. The method of claim 3, wherein the penetration enhancer comprises oleyl alchol. 5. The method of claim 3, wherein the penetration enhancer comprises dipropylene glycol. 6. The method of claim 3, wherein the penetration enhancer comprises oleyl alcohol and dipropylene glycol. 7. The method 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 method of claim 1, wherein the adhesive 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 method of claim 1, wherein the adhesive 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. The method of claim 1, wherein the system achieves an estradiol flux of about 0.0125 mg/cm.sup.2/day, based on the active surface area. 11. The method of claim 1, wherein the system achieves an estradiol flux of about 0.0133 mg/cm.sup.2/day, based on the active surface area. 12. The method of claim 1, wherein the system achieves an estradiol flux of about 0.015 mg/cm.sup.2/day, based on the active surface area. 13. The method of claim 1, wherein the system achieves an estradiol flux of about 0.0167 mg/cm.sup.2/day, based on the active surface area. 14. The method of claim 1, wherein the system achieves an estradiol flux of about 0.0175 mg/cm.sup.2/day, based on the active surface area. 15. The method of claim 1, wherein the adhesive polymer matrix comprises about 1.6% by weight estradiol, based on the total dry weight of the adhesive polymer matrix. 16. A method of making a monolithic transdermal drug delivery system for administering estradiol consisting of (i) a backing layer, (ii) a single adhesive polymer matrix layer and, optionally, (iii) a release liner, comprising forming an adhesive 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 adhesive polymer matrix to a support layer to form a single adhesive polymer matrix layer such that the adhesive polymer matrix layer has a coat weight of greater than about 10 mg/cm.sup.2 and includes greater than 0.156 mg/cm.sup.2 estradiol, wherein the system achieves an estradiol flux of from about 0.0125 to about 0.05 mg/cm.sup.2/day, based on the active surface area. 17. The method of claim 16, 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. 18. The method of claim 16, wherein the system achieves an estradiol flux of about 0.0125 mg/cm.sup.2/day, based on the active surface area. 19. The method of claim 16, wherein the system achieves an estradiol flux of about 0.0133 mg/cm.sup.2/day, based on the active surface area. 20. The method of claim 16, wherein the system achieves an estradiol flux of about 0.015 mg/cm.sup.2/day, based on the active surface area. 21. The method of claim 16, wherein the system achieves an estradiol flux of about 0.0167 mg/cm.sup.2/day, based on the active surface area. 22. The method of claim 16, wherein the system achieves an estradiol flux of about 0.0175 mg/cm.sup.2/day, based on the active surface area. 23. The method of claim 16, wherein the adhesive polymer matrix comprises about 1.6% by weight estradiol, based on the total dry weight of the adhesive polymer matrix.