# US 2013/0156815 A1 · Transdermal estrogen device and delivery > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2013/0156815 A1 - Document ID: US20130156815A1 - Status: Published application - Kind: A1 - Application number: 13/553,972 - Filed: 2012-07-20 - Published: 2013-06-20 - Earliest claimed: 2008-07-10 - Assignees: Noven Pharmaceuticals, Inc. - Inventors: Juan Mantelle - Web page: https://patentgrep.com/patent/US20130156815A1 ## CPC - A61K 9/7069: {obtained otherwise than by reactions only involving carbon to carbon unsaturated bonds, e.g. polysiloxane, polyesters, polyurethane, polyethylene oxide} - A61K 9/0014: {Skin, i.e. galenical aspects of topical compositions (non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00)} - A61K 9/7061: {Polyacrylates} - A61K 31/565: not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol - A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers - A61K 47/32: Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers {, poly(meth)acrylates, or polyvinyl pyrrolidone} - A61P 5/30: Oestrogens - A61P 15/00: Drugs for genital or sexual disorders (for disorders of sex hormones A61P5/24); Contraceptives - A61P 15/12: for climacteric disorders - A61P 17/00: Drugs for dermatological disorders - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## 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. ## Claims ### Claim 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. ### Claim 2 (depends on 1) 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 PVP. ### Claim 3 (depends on 1) 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, about 5-15% penetration enhancer, and about 0.1-10% by weight estradiol, all based on the total dry weight of the polymer matrix. ### Claim 4 (depends on 3) The transdermal drug delivery system of claim 3, wherein the penetration enhancer comprises oleyl alchol. ### Claim 5 (depends on 3) The transdermal drug delivery system of claim 3, wherein the penetration enhancer comprises dipropylene glycol. ### Claim 6 (depends on 3) The transdermal drug delivery system of claim 3, wherein the penetration enhancer comprises oleyl alcohol and dipropylene glycol. ### Claim 7 (depends on 3) 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. ### Claim 8 (depends on 1) 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. ### Claim 9 (depends on 1) 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. ### Claim 10 (canceled) ### Claim 11 (depends on 3) The transdermal drug delivery system of claim 3, wherein the polymer matrix has a coat weight of greater than about 10 mg/cm2. ### Claim 12 (canceled) ### Claim 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. ### Claim 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. ### Claim 15 (depends on 14) The method of claim 14, 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. ### Claim 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. ### Claim 17 (depends on 16) 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 cm2. ### Claim 18 (canceled) ### Claim 19 (depends on 16) The method of claim 16, wherein the polymer matrix is applied to the support layer at a coat weight of greater than about 10 mg/cm2. ### Claim 20 (canceled)