Use of ciclesonide for the treatment of respiratory diseases

• US 20070025923A1
• Filed: 09/15/2004
• Published: 02/01/2007
• Est. Priority Date: 09/16/2003
• Status: Active Grant

• Current Assignee: Covis Pharma GmbH (Apollo Global Management, Inc.)
• Original Assignee: Altana Pharma AG (Takeda Pharmaceutical Company Limited)
• Inventors: Wurst, Wilhelm, Engelstaetter, Renate, Bethke, Thomas
• Granted Patent: US 8,371,292 B2
• Time in Patent Office: Days
• US Class Current: 424/46
• CPC Class Codes: A61K 31/57 substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
• CPC Class Codes: A61K 31/58 containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin digitoxin A61K31/7048
• CPC Class Codes: A61K 9/0075 for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
• 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
• CPC Class Codes: A61P 11/02 Nasal agents, e.g. decongestants
• CPC Class Codes: A61P 11/06 Antiasthmatics
• CPC Class Codes: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 37/08 Antiallergic agents antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14

Abstract

The invention relates to new method of treatment of respiratory diseases, in particular the treatment of asthmatic children.

Claims

1. A method for treating or preventing a respiratory disease in a patient, which patient is a child and the method comprises administering to the patient a dose of a composition containing ciclesonide, or a pharmaceutically acceptable salt, solvate or physiologically functional derivative thereof, wherein the dose of the composition comprises ciclesonide in an amount of from 20 to 200 μ

g.

2. The method according to claim 1, wherein the dose comprises 20, 40, 60, 80, 100, 120, 140, 160, 180 or 200 μ

g of ciclesonide.

3. The method according to claim 1, wherein the dose comprises 40, 80 or 160 μ

g of ciclesonide.

4. The method according to claim 1, wherein the child is a pre-pubertal human.

5. The method according to claim 1, wherein the child is a human from 6 to 12 years of age.

6. The method according to claim 1, wherein the dose is a daily dose in a continuous treatment regimen.

7. The method according to claim 6, wherein the treatment period is more than one day.

8. The method according to claim 7, wherein the treatment period is more than one week.

9. The method according to claim 1, which has no effect on growth rate of the patient.

10. The method according to claim 1, wherein the composition comprises a pharmaceutically acceptable carrier and/or one or more excipients.

11. The method according to claim 1 wherein ciclesonide is selected from the group consisting of [11β

,16α

(R)]-16,17-[(Cyclohexylmethylen)bis(oxy)]-11-hydroxy-21-(2-methyl-1-oxopropoxy)pregna-1,4-dien-3,20-dion, [11β

,16α

(S) ]-16,17-[(Cyclohexylmethylen)bis(oxy)]-11-hydroxy-21-(2-methyl-1-oxoprop-oxy)pregna-1,4-dien3,20-dion, [11β

,16α

(R,S)]-16,17-[(Cyclohexyl-methylen)bis(oxy)]-11-hydroxy-21-(2-methyl-1-oxoprop-oxy)pregna-1,4-dien3,20-dion, 16α

,17-(22R)-Cyclohexylmethylendioxy-11β

,21-dihydroxypregna-1,4-dien-3,20-dion, 16α

,17-(22S)-Cyclohexylmethylendioxy-11β

,21-dihydroxypregna-1,4-dien-3,20-dion and 16α

,17-(22R,S)-Cyclohexylmethylendioxy-11β

,21-dihydroxypregna-1,4-dien-3,20-dion.

12. The method according to claim 1, comprising a once daily dosage regimen.

13. The method according to claim 1, wherein the composition is suitable for administration by inhalation.

14. The method according to claim 13 wherein the composition is a pharmaceutical aerosol formulation comprising a therapeutically effective amount of ciclesonide and a hydrofluorocarbon propellant, and cosolvent in an amount effective to solubilize ciclesonide and optionally a surfactant.

15. The method according to claim 14, wherein the cosolvent is ethanol.

16. The method according to claim 13 wherein the composition is a pharmaceutical aerosol formulation comprising particles of ciclesonide in a therapeutically effective amount and a hydrofluorocarbon propellant and 0.01 to 5% w/w based upon propellant of polar cosolvent and optionally a surfactant.

17. The method according to claim 13 wherein the composition is a dry powder and the carrier is a saccharide.

18. The method according to claim 13 wherein the carrier is lactose monohydrate.

19. The method according to claim 1, wherein the respiratory disease is selected from the group consisting of asthma, nocturnal asthma, exercise-induced asthma, chronic obstructive pulmonary diseases (COPD), chronic bronchitis, wheezy bronchitis, emphysema, respiratory tract infection, upper respiratory tract disease, rhinitis, and allergic and seasonal rhinitis.

20. The method according to claim 1, wherein the respiratory disease is mild or moderate asthma.

21. The method according to claim 1, wherein the ciclesonide consists essentially of R epimer.

43. The method according to claim 14 wherein the hydrofluorocarbon propellant is selected from the group consisting of 1,1,1,2-tetrafluoroethane, 1,1,1,2,3,3,3-heptafluoropropane and mixtures thereof.

44. The method according to claim 16 wherein the hydrofluorocarbon propellant is selected from the group consisting of 1,1,1,2-tetrafluoroethane, 1,1,1,2,3,3,3-heptafluoropropane and mixtures thereof.

22-42. -42. (canceled)