# US 12,109,181 B2 · Lidocaine patch and methods of use thereof

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- Number: US 12,109,181 B2
- Document ID: US12109181B2
- Status: Granted
- Kind: B2
- Application number: 16/785,269
- Filed: 2020-02-07
- Published: 2020-06-11
- Granted: 2024-10-08
- Earliest claimed: 2012-12-20
- Applicants: James Ciullo
- Inventors: James Ciullo
- Web page: https://patentgrep.com/patent/US12109181B2

## CPC

- A61K 31/167: having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
- A61K 9/0009: {involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis}
- A61K 9/7023: {Transdermal patches and similar drug-containing composite devices, e.g. cataplasms (galenical aspects of iontophoretic devices A61K9/0009; microneedle arrays A61K9/0021; buccal patches A61K9/006)}
- A61N 1/0448: {Drug reservoir}
- A61N 1/30: Apparatus for iontophoresis, {i.e. transfer of media in ionic state by an electromotoric force into the body}, or cataphoresis
- 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)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

This invention is directed to a transdermal delivery patch comprising local anesthetic agent and optionally a permeation enhancement agent for reducing neuropathic pain.

## Claims

### Claim 1

A method for reducing pain from degenerative bone disease in a subject comprising applying on a skin surface of the subject a patch for transdermal delivery of lidocaine consisting of a low dose of a therapeutically effective amount of lidocaine and an adhesive that acts as a pharmaceutically acceptable carrier, a permeation enhancer and an excipient wherein said active ingredient consists of 3.6 percent to less than 5 percent lidocaine by weight and wherein said pain from degenerative bone disease consists of pain from microarchitectural deterioration of bone tissue.

### Claim 2

A method for reducing pain from degenerative bone disease in a subject comprising applying on a skin surface of the subject a patch for transdermal delivery of lidocaine consisting of a low dose of a therapeutically effective amount of an active ingredient and an adhesive that acts as a pharmaceutically acceptable carrier, a permeation enhancer and an excipient wherein said active ingredient consists of 3 to less than 4 percent lidocaine by weight and wherein said pain from degenerative bone disease consists of pain from low bone mass.

### Claim 3 (depends on 1)

The method of claim 1 wherein said permeation enhancer comprises menthol.

### Claim 4 (depends on 2)

The method of claim 2 wherein said permeation enhancer comprises menthol.

### Claim 5

A method for reducing pain from low bone mass in a subject without an injection comprising, applying on a skin surface of a subject a patch for transdermal delivery of lidocaine consisting of a low dose of a therapeutically effective amount of an active ingredient and an adhesive that acts as a pharmaceutically acceptable carrier, and a permeation enhancer, and an excipient; wherein pain from low bone mass consists of chronic back pain and wherein said low dose of the therapeutically effective amount of said active ingredient consists of less than 5 percent lidocaine by weight.

### Claim 6 (depends on 5)

The method of claim 5 wherein said permeation enhancer comprises menthol.