# US 12,758,563 B2 · Pharmaceutical compounds and methods of use

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- Number: US 12,758,563 B2
- Document ID: US12758563B2
- Status: Granted
- Kind: B2
- Application number: 17/762,519
- Filed: 2020-09-23
- Published: 2022-11-10
- Granted: 2026-10-13
- Earliest claimed: 2019-09-23
- Assignees: Dermcare-Vet Pty Ltd
- Applicants: Dermcare-Vet Pty Ltd
- Inventors: Kenneth Vincent Mason
- Web page: https://patentgrep.com/patent/US12758563B2

## CPC

- A61K 31/58: containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin (digitoxin {A61K31/7048})
- 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 31/216: of acids having aromatic rings, e.g. benactizyne, clofibrate
- 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)

## Abstract

The present invention relates to pharmaceutical compositions for topical use comprising a corticosteroid and an insecticide selected from pyrethrin or a synthetic pyrethroid insecticide. Methods for their use in treating allergic dermatitis, particularly insect bite hypersensitivity, in animals using the compositions of the invention are also described.

## Claims

### Claim 1

A method of treating insect bite allergic dermatitis in a mammal, the method comprising topical application of a pharmaceutical composition comprising budesonide; permethrin; a silicone excipient; and a pharmaceutically acceptable carrier to the mammal in need thereof.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the silicone excipient is selected from one or more of cyclopentasiloxane, cyclotetrasiloxane and dimethiconol.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the budesonide is in an amount of about 0.05 g/L to about 1 g/L.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the budesonide is in an amount of about 0.25 g/L.

### Claim 5 (depends on 1)

The method according to claim 1, wherein the permethrin is in an amount of about 10 g/L to about 60 g/L.

### Claim 6 (depends on 1)

The method according to claim 1, wherein the permethrin is in an amount of about 40 g/L.

### Claim 7 (depends on 1)

The method according to claim 1, wherein the ratio of budesonide to permethrin is approximately 1:160.

### Claim 8 (depends on 1)

The method according to claim 1, wherein the silicone excipient is in an amount of about 25 g/L to about 150 g/L.

### Claim 9 (depends on 1)

The method according to claim 1, wherein the silicone excipient is in an amount of about 75 g/L.

### Claim 10 (depends on 1)

The method according to claim 1, wherein the composition is a conditioner, a leave-in conditioner, a lotion, a spray, a cream, an ointment or a pour-on formulation.

### Claim 11 (depends on 1)

The method according to claim 1, wherein the composition is a leave-in conditioner.

### Claim 12 (depends on 1)

The method according to claim 1, wherein the composition is applied by pouring or spraying.

### Claim 13 (depends on 1)

The method according to claim 1, wherein the mammal is selected from cattle, pigs, sheep, dogs and equines.

### Claim 14 (depends on 1)

The method according to claim 1, wherein the mammal is a dog or equine.

### Claim 15 (depends on 1)

The method according to claim 1, wherein the mammal is a horse.

### Claim 16 (depends on 1)

The method according to claim 1, wherein the composition is applied to the coat or skin of the backline, mane area, tail area, dorsal midline, ears, head or ventral area of an equine.

### Claim 17 (depends on 1)

The method according to claim 1, wherein the composition is applied to the rump, dorsal thorax, flanks, ears, head or perineal area of a dog.

### Claim 18 (depends on 1)

The method according to claim 1, wherein the composition comprises:
budesonide in an amount of about 0.05 g/L to about 1 g/L;
permethrin in an amount of about 10 g/L to about 60 g/L;
one or more silicone excipients in an amount of about 25 g/L to about 150 g/L; and
a pharmaceutically acceptable aqueous carrier; and optionally
one or more excipients selected from thickening agents, solubilizing agents, chelating agents, antioxidants, preservatives, and pH modifiers.

### Claim 19 (depends on 1)

The method according to claim 1, wherein the composition comprises:
budesonide in an amount of about 0.25 g/L;
permethrin in an amount of about 40 g/L;
one or more silicone excipients in an amount of about 75 g/L;
thickening agents in an amount of about 30 g/L;
one or more excipients selected from solubilizing agents, chelating agents, antioxidants, preservatives, and pH modifiers; and
purified water to 1 L.

### Claim 20 (depends on 19)

The method according to claim 19, wherein the thickening agent is a mixture of Polyquaternium-37, propylene glycol dicaprylate/dicaprate and PPG-1 Trideceth-6.
