# US 10,117,829 B2 · Diclofenac formulations

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

- Number: US 10,117,829 B2
- Document ID: US10117829B2
- Status: Granted
- Kind: B2
- Application number: 15/983,911
- Filed: 2018-05-18
- Published: 2018-09-20
- Granted: 2018-11-06
- Earliest claimed: 2012-07-12
- Assignees: Ferring B.V.
- Applicants: Ferring B.V.
- Inventors: Arnaud Grenier; Dario N. Carrara
- Web page: https://patentgrep.com/patent/US10117829B2

## CPC

- 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 9/006: {Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays}
- A61K 31/196: the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61P 5/24: of the sex hormones
- A61P 9/00: Drugs for disorders of the cardiovascular system
- A61P 13/02: of urine or of the urinary tract, e.g. urine acidifiers
- A61P 15/00: Drugs for genital or sexual disorders (for disorders of sex hormones A61P5/24); Contraceptives
- A61P 15/08: for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
- A61P 17/00: Drugs for dermatological disorders
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61P 19/00: Drugs for skeletal disorders
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 19/04: for non-specific disorders of the connective tissue
- A61P 19/08: for bone diseases, e.g. rachitism, Paget's disease
- A61P 21/00: Drugs for disorders of the muscular or neuromuscular system
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 25/06: Antimigraine agents
- A61P 25/28: for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 31/04: Antibacterial agents
- A61P 35/00: Antineoplastic agents
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- 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
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

The subject invention provides improved diclofenac gel formulations.

## Claims

### Claim 1

A transdermal or transmucosal formulation comprising: about 3% wt of diclofenac, about 45% wt of ethanol, about 20% wt of propylene glycol, about 5% wt of diethylene glycol monoethyl ether, and about 3% wt of myristyl alcohol.

### Claim 2

A transdermal or transmucosal formulation comprising: about 3% wt of diclofenac, about 45% wt of ethanol, about 20% wt of propylene glycol, about 5% wt of diethylene glycol monoethyl ether, about 3% wt of myristyl alcohol, about 1% wt of hydroxypropyl cellulose, and water.

### Claim 3 (depends on 1, 2)

The formulation of claim 1 or 2, wherein the formulation is in the form of a gel, lotion, cream, spray, aerosol, ointment, emulsion, suspension, liposomal system, lacquer, patch, bandage, buccal tablet, wafer, sublingual tablet, suppository, vaginal dosage form, or occlusive dressing.

### Claim 4 (depends on 1, 2)

The formulation of claim 1 or 2, wherein the formulation is in the form of a gel.

### Claim 5 (depends on 1, 2)

The formulation of claim 1 or 2, wherein the formulation is adapted for transdermal or transmucosal administration according to a schedule having a periodicity selected from once to four times daily dosing.

### Claim 6

A method for administering diclofenac to a mammal in need thereof, the method comprising transdermally administering to the skin or a mucosal membrane of a mammal a formulation comprising:
about 3% wt of diclofenac, about 45% wt of ethanol, about 20% wt of propylene glycol, about 5% wt of diethylene glycol monoethyl ether, and about 3% wt of myristyl alcohol.

### Claim 7

A method for treating pain; post-traumatic inflammation of tendons, ligaments, muscles, and joints; localized forms of soft-tissue rheumatism; localized forms of degenerative rheumatism; inflammatory disorders; dysmenorrhea; actinic keratosis caused by over-exposure to sunlight; acute migraine; female breast cancer; pain associated with bony metastases; fever due to malignant lymphogranulomatosis (Hodgkin's lymphoma); multi drug resistant E. coli; Shy-Drager syndrome; and diabetes mellitus, said method comprising transdermally administering to the skin or a mucosal membrane of a mammal a formulation comprising: about 3% wt of diclofenac, about 45% wt of ethanol, about 20% wt of propylene glycol, about 5% wt of diethylene glycol monoethyl ether, and about 3% wt of myristyl alcohol.

### Claim 8 (depends on 7)

The method according to claim 7, wherein the inflammatory disorder is osteoarthritis.

### Claim 9 (depends on 7)

The method according to claim 7, wherein the formulation is administered in combination with another treatment.

### Claim 10

A kit comprising at least one container comprising a formulation comprising:
about 3% wt of diclofenac, about 45% wt of ethanol, about 20% wt of propylene glycol, about 5% wt of diethylene glycol monoethyl ether, and about 3% wt of myristyl alcohol and instructions for use thereof.

### Claim 11 (depends on 10)

The kit according to claim 10, wherein the container is adapted for dispensing a predetermined measured amount of the formulation.