# US 12,005,034 B2 · Topical pharmaceutical composition comprising at least amitriptyline, for the treatment of peripheral neuropathic pain

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 12,005,034 B2
- Document ID: US12005034B2
- Status: Granted
- Kind: B2
- Application number: 16/898,249
- Filed: 2020-06-10
- Published: 2020-09-24
- Granted: 2024-06-11
- Earliest claimed: 2017-04-25
- Assignees: Algotherapeutix
- Applicants: Algotherapeutix
- Inventors: Céline Gréco
- Web page: https://patentgrep.com/patent/US12005034B2

## CPC

- A61K 31/135: having aromatic rings {, e.g. ketamine, nortriptyline (methadone A61K31/137)}
- 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 9/06: Ointments; Bases therefor; {Other semi-solid forms, e.g. creams, sticks, gels (composition of ointments, creams or gels A61K47/00)}
- A61K 9/107: Emulsions {; Emulsion preconcentrates; Micelles (composition of emulsions A61K47/00)}
- A61K 47/14: Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
- A61K 47/32: Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers {, poly(meth)acrylates, or polyvinyl pyrrolidone}
- A61K 47/44: Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin (synthetic glycerides, e.g. medium-chain triglycerides, A61K47/14)
- A61P 23/02: Local anaesthetics
- 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

The present disclosure relates to a pharmaceutical composition comprising from 10% to 30% by weight of amitriptyline or of a pharmaceutically acceptable salt or ester thereof, relative to the total weight of the composition, amitriptyline, for use in the topical treatment of chemotherapy-induced peripheral neuropathic pain.

## Claims

### Claim 1

A pharmaceutical composition for the topical treatment of chemotherapy-induced peripheral neuropathic pain comprising, in a pharmaceutically acceptable carrier suitable for topical application, from 10.5% to 30% by weight, relative to the total weight of the composition, of amitriptyline or a pharmaceutically acceptable salt thereof, from 2% to 8% by weight of one or more surfactants chosen from sorbitan esters, glycerol esters, and mixtures of these compounds, —from 15% to 25% by weight of one or more fatty substances chosen from mineral oils, fatty acids, waxes and mixtures of these compounds, —from 0.1% to 4% by weight of one or more gelling agents chosen from carboxyvinyl polymers, —from 7% to 15% by weight of one or more hydrating active agents, —optionally from 0 to 3% by weight of one or more preservatives, —optionally from 0 to 1% by weight of one or more pH adjusters, and —water; wherein the amitriptyline or the pharmaceutically salt thereof is the sole agent for treating neuropathic pain.

### Claim 2 (depends on 1)

Composition according to claim 1, for use in the treatment of chemotherapy-induced peripheral neuropathic pain, by application to the peripheral parts (hands and feet).

### Claim 3 (depends on 1)

Composition according to claim 1, characterized in that it comprises from 10.5% to 20% by weight, relative to the total weight of the composition, of amitriptyline or of a pharmaceutically acceptable salt thereof.

### Claim 4

A pharmaceutical composition for the topical treatment of chemotherapy-induced peripheral neuropathic pain comprising, in a pharmaceutically acceptable carrier suitable for topical application,
from 10.5% to 30% by weight of amitriptyline or of a pharmaceutically acceptable salt thereof,
from 2% to 8% by weight of a mixture of one or more sorbitan esters and of one or more glycerol esters,
from 15% to 25% by weight of a mixture of one or more mineral oils, of one or more fatty acids and of one or more waxes,
from 0.1% to 4% by weight of one or more carboxyvinyl polymers,
from 7% to 15% by weight of glycerol,
optionally from 0 to 3% by weight of one or more preservatives,
optionally from 0 to 1% by weight of one or more pH adjusters, and
water; wherein the amitriptyline or the pharmaceutically salt thereof is the sole agent for treating neuropathic pain.

### Claim 5 (depends on 1)

Composition according to claim 1, characterized in that it is in the form of a cream.