Muscarinic antagonists and combinations thereof for the treatment of airway disease in horses

• US 9,474,747 B2
• Filed: 06/16/2015
• Issued: 10/25/2016
• Est. Priority Date: 06/18/2014
• 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: Lamar, Janine, Albrecht, Balazs, Aven, Michael
• Primary Examiner(s): VAJDA, KRISTIN ANN
• Application Number:
  US14/740,582
• Publication Number:
  US 20150366855A1
• Time in Patent Office: 497 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/46 8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
• CPC Class Codes: A61K 31/58 containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin digitoxin A61K31/7048
• CPC Class Codes: A61K 35/06 Mineral oils, e.g. paraffinic oils or aromatic oils based on aromatic hydrocarbons
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• 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 9/008 comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
• CPC Class Codes: A61M 15/009 using medicine packages with incorporated spraying means, e.g. aerosol cans pocket atomiser of the injector type A61M11/08
• CPC Class Codes: A61M 2250/00 Specially adapted for animals
• 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 specifically relates to muscarinic antagonists (including long acting muscarinic antagonists (LAMAs)) for the treatment of airway disease, such as pulmonary disease, preferably recurrent airway obstruction (RAO), summer pasture associated obstructive pulmonary disease (SPAOPD), and inflammatory airway disease (IAD) in animals, preferably equines such as horses.

Claims

1. A method of treating an airway disease in an equine, comprising administering to the equine a composition comprising a long-acting muscarinic antagonist (LAMA) or another pharmaceutically acceptable salt of the cation thereof.

2. The method according to claim 1, wherein the LAMA is a compound of the general formula:

3. The method according to claim 2, wherein the concentration of LAMA ranges between 0.2 to 7% m/V of the composition.

4. The method according to claim 2, wherein the concentration of LAMA ranges between 0.3 to 6.0% m/V of the composition.

5. The method according to claim 2, wherein the concentration of LAMA ranges between 0.4 to 5% m/V of the composition.

21. The method according to claim 1, wherein said LAMA or the pharmaceutical composition comprising the LAMA is administered via an inhaler device comprising:

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

b. an adapter for equine use.

22. The method according to claim 21, wherein said LAMAor the pharmaceutical composition comprising the LAMA is administered as an aerosol via the inhaler device.

23. The method according to claim 21, wherein said LAMA or a pharmaceutically acceptable salt of the cation thereof is administered at a dose of 100 μ

g to 3000 μ

g ex inhaler.

24. The method according to claim 21, wherein said dose is 200 μ

g to 2000 μ

g ex inhaler.

25. The method according to claim 21, wherein said dose is 200 μ

g to 800 μ

g ex inhaler.

26. The method according to claim 21, wherein ciclesonide or a pharmaceutically acceptable salt thereof is administered at a dose of 100 μ

g to 5000 μ

g ex inhaler.

27. The method according to claim 21, wherein the dose is 450 μ

g to 3712.5 μ

g ex inhaler.

28. The method according to claim 21, wherein the dose is 900 μ

g to 3712.5 μ

g ex inhaler.

29. The method according to claim 1, wherein said composition is administered once or twice a day.

30. The method according to claim 1, wherein the LAMA is a compound of the formula (LAMA 1):

6. A method of administering a medicament to an animal, the method comprising administering to the animal a composition comprising a long-acting muscarinic antagonist (LAMA) or another pharmaceutically acceptable salt of the cation thereof in combination with a glucocorticoid.

7. The method according to claim 6, wherein the animal is a mammal.

8. The method according to claim 7, wherein the mammal is an equine.

9. The method according to claim 6, wherein said glucocorticoid is ciclesonide or budesonide or a pharmaceutically acceptable salt thereof.

10. The method according to claim 9, wherein said glucocorticoid is ciclesonide.

11. The method of claim 8, wherein the method of administering further comprises a method for treating the equine for an airway disease.

12. The method according to claim 11, wherein said glucocorticoid is ciclesonide, budesonide, or pharmaceutically acceptable salts thereof.

13. The method according to claim 11, wherein said composition further comprises a beta-2 adrenoreceptor agonist.

14. The method according to claim 13, wherein said beta-2 adrenoreceptor agonist is a long-acting beta-2 adrenergic agonist (LABA) or a pharmaceutically acceptable salt thereof.

15. The method according to claim 11, wherein said pharmaceutical composition further comprises a pharmaceutically acceptable excipient.

16. The method according to claim 11, wherein the LAMA is a compound of the general formula:

17. The method according to claim 16, wherein the airway disease is a pulmonary disease, preferably 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).

18. The method according to claim 17, wherein said LAMA or the composition comprising the LAMA is in a liquid formulation.

19. The method according to claim 18, wherein said liquid formulation is a partially ethanolic formulation.

20. The method according to claim 18, wherein said liquid formulation is for inhalation.

31. The method according to claim 11, wherein the LAMA is a compound of the formula (LAMA 1):