CICLESONIDE FOR THE TREATMENT OF AIRWAY DISEASE IN HORSES

• US 20170079988A1
• Filed: 10/13/2016
• Published: 03/23/2017
• 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 10,258,634 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

The invention relates to the field of medicine, in particular to the field of veterinary medicine. The invention relates to glucocorticoids, especially ciclesonide or a pharmaceutically acceptable derivative or salt thereof, for the treatment of airway disease in horses, such as pulmonary disease, preferably recurrent airway obstruction (RAO), Summer Pasture Associated Obstructive Pulmonary disease (SPAOPD), and inflammatory airway disease (IAD).

Claims

1. A method of treating an airway disease in equines comprising administering an effective amount of ciclesonide or a pharmaceutically acceptable salt thereof or a composition comprising ciclesonide or a pharmaceutically acceptable salt thereof;

wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is administered at a dose of 100 ug to 5000 ug ex inhaler.

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 according to claim 3, wherein the airway disease is RAO.

5. The method 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 solvents selected from the group consisting of water, ethanol, hydrofluoroalkanes, hydrofluoroolefin, and excipients.

8. The method of claim 7, wherein the hydrofluoroalkanes are HFA 227, HFA 134a, and combinations thereof.

9. The method of claim 7, wherein the hydrofluoroolefin is HFO1234ze.

10. The method of claim 6, wherein the solvent in the liquid formulation is partially aqueous and partially ethanol.

11. The method of claim 10, wherein the solvent in the liquid formulation comprises of a mixture of ≧

85% V/V ethanol and ≦

15% V/V water.

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

13. The method of claim 6, wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is administered via an inhaler device.

14. The method of claim 13, wherein the inhaler device comprises:

a. a pressurized metered dose inhaler or a aqueous/ ethanolic droplet inhaler comprising the RESPIMAT®

inhaler or another inhalation device using the RESPIMAT®

aerosol-generating technology; and

b. an adapter for equine use.

15. The method of claim 6, 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 via an inhaler device.

16. The method of claim 15, wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is administered at a dose of at least 900μ

g ex inhaler, at least 1800μ

g ex inhaler, or at least 2700 μ

g ex inhaler.

17. The method of claim 16, wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is administered at a dose of 450 μ

g to 2700 μ

g ex inhaler.

18. The method of claim 16, wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is administered at a dose of 900 μ

g to 2700 μ

g ex inhaler.

19. The method of claim 6, wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is administered with less than 20 actuations per dose.

20. The method of claim 19, wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is administered with 12, 11, 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1 actuations per dose.

21. The method of claim 20, wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is administered using 8 or fewer actuations per dose.

22. The method of claim 6, wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is administered in 1 to 3 doses per day.

23. The method of claim 22, wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is administered in 1 to 2 doses per day.

24. The method of claim 6, wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is administered over a time period of at least 1 week.

25. The method of claim 24, wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is administered over a time period of at least 10 weeks.

26. A method according to claim 1, wherein the composition comprises a solution including 0.7-3.1 g ciclesonide/100 mL.

27. A method of treating an airway disease in equines comprising administering an effective amount of ciclesonide or a pharmaceutically acceptable salt thereof or a composition comprising ciclesonide or a pharmaceutically acceptable salt thereof;

wherein the ciclesonide or the pharmaceutically acceptable salt thereof or the composition comprising ciclesonide or the pharmaceutically acceptable salt thereof is administered at a dose of 1800 μ

g to 5000 μ

g ex inhaler.