# US 8,784,877 B2 · Transdermal levonorgestrel 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 8,784,877 B2
- Document ID: US8784877B2
- Status: Granted
- Kind: B2
- Application number: 13/337,594
- Filed: 2011-12-27
- Published: 2012-07-26
- Granted: 2014-07-22
- Earliest claimed: 2010-12-29
- Assignees: Noven Pharmaceuticals, Inc.
- Applicants: David W. Houze; Vincent Lau Chan
- Inventors: David W. Houze; Vincent Lau Chan
- Web page: https://patentgrep.com/patent/US8784877B2

## CPC

- A61K 9/7061: {Polyacrylates}
- A61K 9/7069: {obtained otherwise than by reactions only involving carbon to carbon unsaturated bonds, e.g. polysiloxane, polyesters, polyurethane, polyethylene oxide}
- A61K 31/567: substituted in position 17 alpha, e.g. mestranol, norethandrolone
- A61P 5/00: Drugs for disorders of the endocrine system
- A61P 5/34: Gestagens
- 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 levonorgestrel, comprising a polymer matrix and levonorgestrel acetate. Methods of making and using such systems also are described.

## Claims

### Claim 1

A transdermal drug delivery system comprising a polymer matrix comprising about 5-60% by weight acrylic adhesive, about 20-80% by weight silicone adhesive, about 1-20% by weight soluble PVP, up to about 15% by weight penetration enhancer, and about 1-15% by weight levonorgestrel acetate, wherein the levonorgestrel acetate is present in an amount at or below its saturation concentration in the polymer matrix.

### Claim 2 (depends on 1)

The transdermal drug delivery system of claim 1, comprising from about 1% to about 15% by weight levonorgestrel acetate, based on the total weight of the polymer matrix.

### Claim 3 (depends on 1)

The transdermal drug delivery system of claim 1, comprising from about 1% to about 8% by weight levonorgestrel acetate, based on the total weight of the polymer matrix.

### Claim 4 (depends on 1)

The transdermal drug delivery system of claim 1, comprising from about 1% to about 6% by weight levonorgestrel acetate, based on the total weight of the polymer matrix.

### Claim 5 (depends on 1)

The transdermal drug delivery system of claim 1, comprising from about 1% to about 3% by weight levonorgestrel acetate, based on the total weight of the polymer matrix.

### Claim 6 (depends on 1)

The transdermal drug delivery system of claim 1, comprising from about 2% to about 6% by weight levonorgestrel acetate, based on the total weight of the polymer matrix.

### Claim 7 (depends on 1)

The transdermal drug delivery system of claim 1, wherein the polymer matrix comprises about 5% by weight acrylic adhesive, about 74% by weight silicone adhesive, about 10% by weight soluble PVP, about 8.0% by weight oleyl alcohol, and about 3% by weight levonorgestrel acetate.

### Claim 8

A transdermal drug delivery system comprising a polymer matrix comprising about 5-60% by weight acrylic adhesive, about 20-80% by weight silicone adhesive, about 1-20% by weight soluble PVP, up to about 15% by weight penetration enhancer, and about 1-15% by weight levonorgestrel acetate as an active agent wherein said levonorgestrel acetate transdermal drug delivery system exhibits a greater flux of the active agent than a corresponding transdermal drug delivery system comprising levonorgestrel as the active agent, wherein the transdermal drug delivery systems each comprise amounts of levonorgestrel acetate or levonorgestrel respectively, that are at or near but below the active agent's saturation concentration in the polymer matrix.

### Claim 9

A transdermal drug delivery system comprising a polymer matrix, wherein the polymer matrix comprises about 5-60% by weight acrylic adhesive, about 20-80% by weight silicone adhesive, about 1-20% by weight soluble PVP, up to about 15% by weight penetration enhancer, and about 1-15% by weight levonorgestrel acetate, wherein the polymer matrix defines an active surface area, wherein said levonorgestrel acetate transdermal drug delivery system delivers at least the same amount of the active agent as a corresponding transdermal drug delivery system comprising levonorgestrel as the active agent and having an active surface area at least about 1.33 times larger than the active surface area of said levonorgestrel acetate transdermal drug delivery system.

### Claim 10

A method for providing contraception or hormone replacement therapy, the method comprising administering a transdermal drug delivery system comprising a polymer matrix comprising about 5-60% by weight acrylic adhesive, about 20-80% by weight silicone adhesive, about 1-20% by weight soluble PVP, up to about 15% by weight penetration enhancer, and about 1-15% by weight levonorgestrel acetate, wherein the levonorgestrel acetate is present in an amount at or below its saturation concentration in the polymer matrix.

### Claim 11 (depends on 10)

The method of claim 10, wherein the transdermal drug delivery system delivers a therapeutically effective amount of levonorgestrel acetate over an extended period of 3 days or longer.

### Claim 12

A method of enhancing transdermal drug delivery of levonorgestrel, comprising providing a transdermal drug delivery system comprising a polymer matrix comprising about 5-60% by weight acrylic adhesive, about 20-80% by weight silicone adhesive, about 1-20% by weight soluble PVP, up to about 15% by weight penetration enhancer, and about 1-15% by weight levonorgestrel acetate, wherein the polymer matrix defines an active surface area, and wherein the levonorgestrel acetate is present in an amount at or below its saturation concentration in the polymer matrix.

### Claim 13 (depends on 12)

The method of claim 12, wherein said levonorgestrel acetate transdermal drug delivery system exhibits a greater flux of the active agent than a corresponding transdermal drug delivery system comprising levonorgestrel as the active agent, wherein the transdermal drug delivery systems each comprise amounts of levonorgestrel acetate or levonorgestrel, respectively, that are at or near but below the active agent's saturation concentration in the polymer matrix.

### Claim 14 (depends on 12)

The method of claim 12, wherein said levonorgestrel acetate transdermal drug delivery system delivers at least the same amount of active agent as a corresponding transdermal drug delivery system comprising levonorgestrel as the active agent and having an active surface area at least about 1.33 times larger than the active surface area of said levonorgestrel acetate transdermal drug delivery system.
