Ciclesonide for the Treatment of Airway Disease in Horses

• US 20180153907A1
• Filed: 02/06/2018
• Published: 06/07/2018
• Est. Priority Date: 12/21/2012
• Status: Active Grant

• Current Assignee: Boehringer Ingelheim Vetmedica GmbH (C.H. Boehringer Sohn AG & Co. KG)
• Original Assignee: Boehringer Ingelheim Vetmedica GmbH (C.H. Boehringer Sohn AG & Co. KG)
• Inventors: ALBRECHT, Balazs, AVEN, Michael, LAMAR, Janine, LANG, Ingo
• Granted Patent: US 10,441,597 B2
• Time in Patent Office: Days
• CPC Class Codes: A61K 31/58 containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin digitoxin A61K31/7048
• CPC Class Codes: 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
• CPC Class Codes: 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
• CPC Class Codes: A61K 9/008 comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system

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

1. A method of treating an airway disease in an equine comprising administering 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.

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

3. 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).

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

5. 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.

6. 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.

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

8. 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.

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

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

11. The method of claim 7, wherein the liquid formulation comprises a mixture of ≥

85% V/V ethanol and ≤

15% V/V water.

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

13. 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.

14. 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.

15. 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.

16. 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 μ

g ex inhaler, at least 1800 μ

g ex inhaler, at least 2700 μ

g ex inhaler, and at least 2700 μ

g ex inhaler.

17. 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 μ

g to 5000 μ

g ex inhaler.

18. 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.

19. 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.

20. 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.

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