CICLESONIDE FOR THE TREATMENT OF AIRWAY DISEASE IN HORSES

• US 20140179651A1
• Filed: 12/18/2013
• Published: 06/26/2014
• Est. Priority Date: 12/21/2012
• Status: Abandoned Application

• 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: AVEN, Michael, LANG, Ingo, ALBRECHT, Balazs, LAMAR, Janine
• Application Number:
  US14/132,580
• Publication Number:
  US 20140179651A1
• Time in Patent Office: Days
• US Class Current: 514/174
• 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.

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

3. The method according to 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 said ciclesonide or said pharmaceutically acceptable salt thereof or said composition comprising ciclesonide or said pharmaceutically acceptable salt thereof is inhalable.

6. A method according to claim 1, wherein said ciclesonide or said pharmaceutically acceptable salt thereof or said composition comprising ciclesonide or said pharmaceutically acceptable salt thereof is in a liquid formulation.

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

8. A method according to claim 7, wherein said hydrofluoroalkanes are HFA 227, HFA 134a, and combinations thereof.

9. A method according to claim 7, wherein said hydrofluoroolefin is HFO1234ze.

10. A method according to claim 6, wherein the solvent in said liquid formulation is partially aqueous and partially ethanol.

11. A method according to claim 10, wherein the solvent in said liquid formulation comprises of a mixture of ≧

85% V/V ethanol and ≦

15% V/V water.

12. A method according to claim 10, wherein the solvent in said liquid formulation comprises 10% V/V water and 90% V/V ethanol.

13. A method according to claim 6, wherein said ciclesonide or said pharmaceutically acceptable salt thereof or said composition comprising ciclesonide or said pharmaceutically acceptable salt thereof is administered via an inhaler device.

14. The method according to claim 13, whereby said inhaler device comprises:

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

inhaler or another inhalation device using the RESPIMAT®

aerosol-generating technology and

b. an adapter for equine use.

15. A method according to claim 6, wherein said ciclesonide or said pharmaceutically acceptable salt thereof or said composition comprising ciclesonide or said pharmaceutically acceptable salt thereof is a partially ethanolic formulation and is administered via an inhaler device.

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

g ex inhaler, at least 1800 μ

g ex inhaler, or at least 2700 μ

g ex inhaler, preferably at least 2700 μ

g ex inhaler.

17. A method according to claim 16, wherein said ciclesonide or said pharmaceutically acceptable salt thereof or said composition comprising ciclesonide or said pharmaceutically acceptable salt thereof is administered at a dose of 100 μ

g to 5000 μ

g ex inhaler.

18. A method according to claim 16, wherein said ciclesonide or said pharmaceutically acceptable salt thereof or said composition comprising ciclesonide or said pharmaceutically acceptable salt thereof is administered at a dose of 450 μ

g to 2700 μ

g ex inhaler.

19. A method according to claim 16, wherein said ciclesonide or said pharmaceutically acceptable salt thereof or said composition comprising ciclesonide or said pharmaceutically acceptable salt thereof is administered at a dose of 900 μ

g to 2700 μ

g ex inhaler.

20. A method according to claim 6, wherein said ciclesonide or said pharmaceutically acceptable salt thereof or said composition comprising ciclesonide or said pharmaceutically acceptable salt thereof is administered with less than 20 actuations per dose.

21. A method according to claim 20, wherein, said ciclesonide or said pharmaceutically acceptable salt thereof or said composition comprising ciclesonide or said pharmaceutically acceptable salt thereof is administered with 12, 11, 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1 actuations per dose.

22. A method according to claim 21, wherein said ciclesonide or said pharmaceutically acceptable salt thereof or said composition comprising ciclesonide or said pharmaceutically acceptable salt thereof is administered using 8 or fewer actuations per dose.

23. A method according to claim 6, wherein said ciclesonide or said pharmaceutically acceptable salt thereof or said composition comprising ciclesonide or said pharmaceutically acceptable salt thereof is administered in 1 to 3 doses per day.

24. A method according to claim 23, wherein said ciclesonide or said pharmaceutically acceptable salt thereof or said composition comprising ciclesonide or said pharmaceutically acceptable salt thereof is administered in 1 to 2 doses per day.

25. A method according to claim 6, wherein said ciclesonide or said pharmaceutically acceptable salt thereof or said composition comprising ciclesonide or said pharmaceutically acceptable salt thereof is administered over a time period of at least 1 week.

26. A method according to claim 25, wherein said ciclesonide or said pharmaceutically acceptable salt thereof or said composition comprising ciclesonide or said pharmaceutically acceptable salt thereof is administered over a time period of at least 10 weeks.