# US 10,441,597 B2 · Ciclesonide for the treatment of airway disease in horses

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- Number: US 10,441,597 B2
- Document ID: US10441597B2
- Status: Granted
- Kind: B2
- Application number: 15/889,307
- Filed: 2018-02-06
- Published: 2018-06-07
- Granted: 2019-10-15
- Earliest claimed: 2012-12-21
- Applicants: Boehringer Ingelheim Vetmedica GmbH
- Inventors: Balazs Albrecht; Michael Aven; Janine Lamar; Ingo Lang
- Web page: https://patentgrep.com/patent/US10441597B2

## CPC

- A61K 31/58: containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin (digitoxin {A61K31/7048})
- A61K 9/0073: {Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy; (nasal sprays A61K9/0043; inhalation of vapours of volatile or heated drugs, e.g. essential oils or nicotine, A61K9/007; devices A61M)}
- A61K 9/0078: {for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions}
- A61K 9/008: {comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]}
- A61P 11/00: Drugs for disorders of the respiratory system
- 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

Methods of treating airway diseases in equines include administering to an equine an effective amount of ciclesonide or a pharmaceutically acceptable salt thereof or a composition including ciclesonide or a pharmaceutically acceptable salt thereof.

## Claims

### Claim 1

A method of treating an airway disease in an equine comprising administering by inhalation to the equine an effective amount of ciclesonide or a pharmaceutically acceptable salt thereof or a composition comprising ciclesonide or a pharmaceutically acceptable salt thereof.

### Claim 2 (depends on 1)

The method of claim 1, wherein the airway disease is a pulmonary disease.

### Claim 3 (depends on 1)

The method of claim 1, wherein the airway disease is selected from the group consisting of: recurrent airway obstruction (RAO), summer pasture associated obstructive pulmonary disease (SPAOPD), and inflammatory airway disease (IAD).

### Claim 4 (depends on 1)

The method of claim 1, wherein the airway disease is RAO.

### Claim 5 (depends on 1)

The method of claim 1, wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is inhalable.

### Claim 6 (depends on 1)

The method of claim 1, wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is in a liquid formulation.

### Claim 7 (depends on 6)

The method of claim 6, wherein the liquid formulation comprises one or more of the solvents water, ethanol, hydrofluoroalkanes, hydrofluoroolefin or excipients.

### Claim 8 (depends on 7)

The method of claim 7, wherein the one or more solvents include one or more hydrofluoroalkanes selected from the group consisting of HFA 227, HFA 134a, and combinations thereof.

### Claim 9 (depends on 7)

The method of claim 7, wherein the one or more solvents include HFO1234ze.

### Claim 10 (depends on 7)

The method of claim 7, wherein the liquid formulation is partially aqueous and partially ethanol.

### Claim 11 (depends on 7)

The method of claim 7, wherein the liquid formulation comprises a mixture of ≥85% V/V ethanol and ≤15% V/V water.

### Claim 12 (depends on 7)

The method of claim 7, wherein the liquid formulation comprises 10% V/V water and 90% V/V ethanol.

### Claim 13 (depends on 1)

The method of claim 1, wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is administered to the equine via an inhaler device.

### Claim 14 (depends on 13)

The method of claim 13, whereby the inhaler device comprises:
a. a pressurized metered dose inhaler or aqueous/ethanolic droplet inhaler; and
b. an adapter for equine use.

### Claim 15 (depends on 1)

The method of claim 1, wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is a partially ethanolic formulation and is administered to the equine via an inhaler device.

### Claim 16 (depends on 13)

The method of claim 13, wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is administered to the equine at a dose selected from the group consisting of: at least 900 μg ex inhaler, at least 1800 μg ex inhaler, at least 2700 μg ex inhaler, and at least 2700 μg ex inhaler.

### Claim 17 (depends on 13)

The method of claim 13, wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is administered to the equine at a dose of 100 μg to 5000 μg ex inhaler.

### Claim 18 (depends on 13)

The method of claim 13, wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is administered to the equine with less than 20 actuations per dose, or 12, 11, 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1 actuation per dose.

### Claim 19 (depends on 13)

The method of claim 13, wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is administered to the equine in 1 to 3 doses per day, or in 1 to 2 doses per day.

### Claim 20 (depends on 1)

The method of claim 1, wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is administered to the equine over an extended time period selecting from the group consisting of at least 1 week, at least 2 weeks, at least 3 weeks, at least 4 weeks, at least 5 weeks, at least 6 weeks, at least 7 weeks, at least 8 weeks, at least 9 weeks, and at least 10 weeks.

### Claim 21 (depends on 1)

The method of claim 1, wherein the equine is a horse.