Ciclesonide for the treatment of airway disease in horses

• US 9,918,995 B2
• Filed: 12/18/2013
• Issued: 03/20/2018
• 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
• Primary Examiner(s): Anderson, James D.
• Application Number:
  US14/654,009
• Publication Number:
  US 20150313918A1
• Time in Patent Office: 1,553 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 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 by inhalation to an equine having an airway disease an effective amount of ciclesonide or a pharmaceutically acceptable salt thereof or a composition comprising ciclesonide or a pharmaceutically acceptable salt thereof during a treatment period comprising a first portion and optionally a second portion, wherein the effective amount administered during the first portion of the treatment period comprises a daily dose of at least 5000 μ

g ex inhaler for consecutive days and the effective amount administered during the optional second portion of the treatment period comprises a daily dose of at least 100 μ

s to 5000 μ

g ex inhaler.

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. 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.

6. A method according to claim 5, wherein said liquid formulation comprises one or more of the solvents water, ethanol, hydrofluoroalkanes, hydrofluoroolefin or excipients.

7. A method according to claim 6, wherein said hydrofluoroalkanes are HFA 227, HFA 134a, and combinations thereof.

8. A method according to claim 6, wherein said hydrofluoroolefin is HFO1234ze.

9. A method according to claim 5, wherein the solvent in said liquid formulation is partially aqueous and partially ethanol.

10. A method according to claim 9, wherein the solvent in said liquid formulation comprises of a mixture of ≥

85% V/V ethanol and ≤

15% V/V water.

11. A method according to claim 9, wherein the solvent in said liquid formulation comprises 10% V/V water and 90% V/V ethanol.

12. A method according to claim 5, 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.

13. The method according to claim 12, whereby said inhaler device comprises:

a. a pressurized metered dose inhaler or a aqueous/ethanolic droplet inhaler; and

b. an adapter for equine use.

14. A method according to claim 5, 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.

15. A method according to claim 14, wherein the method includes both the first and second portions, and the effective amount administered during the second portion of the treatment period comprises a daily dose of at least 900 μ

g ex inhaler, at least 1800 μ

g ex inhaler, or at least 2700 μ

g ex inhaler.

16. The method according to claim 1, wherein the method includes both the first and second portions, and wherein the effective amount administered during the treatment period comprises a first dose administered twice daily for a period of 5-7 days during the first portion and a second dose administered once daily for a period of 5-7 days during the second portion.

17. The method according to claim 16, wherein the first dose is 2700 μ

g ex inhaler administered twice daily and the second dose is 3712.5 μ

g ex inhaler administered once daily.

18. The method according to claim 1, wherein the composition comprises a solution comprising 0.7-3.1 g ciclesonide/100 mL.

20. The method according to claim 1, wherein the effective amount administered during a treatment period of two weeks results in a decrease in a cortisol level within the blood of the equine of no greater than 19% after the treatment period of two weeks.

19. A method of treating an airway disease in equines comprising administering by inhalation to an equine an effective amount of ciclesonide or a pharmaceutically acceptable salt thereof or a composition comprising ciclesonide or a pharmaceutically acceptable salt thereof, wherein the effective amount results in no significant reduction in a cortisol level within the blood of the equine after treatment for a period of two weeks.