# US 10,307,380 B1 · Composition and method for transdermal lidocaine delivery

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- Number: US 10,307,380 B1
- Document ID: US10307380B1
- Status: Granted
- Kind: B1
- Application number: 15/281,324
- Filed: 2016-09-30
- Granted: 2019-06-04
- Earliest claimed: 2014-03-04
- Assignees: ProSolus, Inc.
- Applicants: ProSolus, Inc.
- Inventors: Juan A. Mantelle
- Web page: https://patentgrep.com/patent/US10307380B1

## CPC

- A61K 9/7053: {obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene}
- A61K 31/167: having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
- B65D 65/38: Packaging materials of special type or form
- B65D 75/30: Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
- 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)
- B65D: CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES

## Abstract

Adhesive formulations are provides for manufacturing matrix-type lidocaine patches having improved performance, manufacturability and stability.

## Claims

### Claim 1

A packaged matrix-type transdermal drug delivery system inside a sealed package, wherein:
a) said transdermal drug delivery system comprises (1) an adhesive matrix layer comprising a lidocaine base in a polyisobutylene adhesive matrix, wherein the adhesive matrix layer comprises from about 3.0 to about 5.0 weight parts lidocaine base, from about 84.0 to about 94.0 weight parts polyisobutylene, and from about 3.0 to about 7.0 weight parts cross-linked homopolymer of N-vinyl-2-pyrrolidone, and (2) a non-woven fabric backing layer; and
b) said sealed package comprises opposing layers of an acrylonitrile-methyl acrylate copolymer and foil liner.

### Claim 2 (depends on 1)

The packaged transdermal drug delivery system of claim 1, wherein the adhesive matrix further comprises from about 18.0 to about 24.0 weight parts mineral oil.

### Claim 3 (depends on 1)

The packaged transdermal drug delivery system of claim 1, wherein the adhesive matrix layer further comprises a sensate.

### Claim 4 (depends on 3)

The packaged transdermal drug delivery system of claim 3, wherein the sensate comprises methanediol, methoxypropanediol, isopulegol, vanillyl butyl ether, or a combination thereof.

### Claim 5 (depends on 4)

The packaged transdermal drug delivery system of claim 4, wherein the sensate comprises methoxypropanediol and vanillyl butyl ether.

### Claim 6 (depends on 5)

The packaged transdermal drug delivery system of claim 5, wherein the adhesive matrix layer comprises from about 0.5 to about 1.5 weight parts methoxypropanediol.

### Claim 7 (depends on 5)

The packaged transdermal drug delivery system of claim 5, wherein the adhesive matrix layer comprises from about 0.05 to about 0.15 weight parts vanillyl butyl ether.

### Claim 8 (depends on 1)

The packaged transdermal drug delivery system of claim 1, wherein the transdermal drug delivery system further comprises a release liner.

### Claim 9 (depends on 1)

The packaged transdermal drug delivery system of claim 1, wherein the non-woven fabric backing layer comprises polyethylene, polyester, polypropylene, polyurethane, polyvinyl alcohol, polyvinyl chloride, polyvinylidene, polyamide, vinyl acetate, an ethylene/vinyl acetate copolymer, an ethylene/ethylacrylate copolymer, a metal-vapor deposited film or sheet, a rubber film or sheet, a foil, paper, or a combination thereof.

### Claim 10 (depends on 9)

The packaged transdermal drug delivery system of claim 9, wherein the non-woven fabric backing layer comprises polyester.

### Claim 11 (depends on 8)

The packaged transdermal drug delivery system of claim 8, wherein the release liner comprises a fluoropolymer and silicone coated film.