Combination medicament

• US 8,258,124 B2
• Filed: 12/20/2010
• Issued: 09/04/2012
• Est. Priority Date: 12/12/2002
• Status: Expired due to Term

• Current Assignee: Covis Pharma GmbH (Apollo Global Management, Inc.)
• Original Assignee: Nycomed GmbH (Takeda Pharmaceutical Company Limited)
• Inventors: Weimar, Christian, Dietzel, Klaus, Müller, Helgert, Marx, Degenhard
• Primary Examiner(s): Jean-Louis, Samira
• Application Number:
  US12/973,350
• Publication Number:
  US 20110086827A1
• Time in Patent Office: 624 Days
• Field of Search: 514/171, 514/174, 540/63, 540/70, 552/564, 552/566
• US Class Current: 514/171
• CPC Class Codes: A61K 31/575 substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 11/06 Antiasthmatics
• CPC Class Codes: A61P 11/08 Bronchodilators

Abstract

The subject matter of this application relates to the combination of ciclesonide or an epimer thereof with R,R-formoterol or a salt, or a hydrate of a salt thereof.

Claims

1. A pharmaceutical composition comprising as the sole active compounds a combination of the active compound ciclesonide or an epimer thereof and the active compound R,R-formoterol or a salt thereof, and optionally comprising excipients and/or vehicles.

2. The pharmaceutical composition according to claim 1, wherein the active compound ciclesonide is present as its R epimer in an amount greater than 95%.

3. The pharmaceutical composition according to claim 1, wherein the active compound ciclesonide is present as its R epimer in an amount greater than 95%, and the active compound R,R-formoterol is present as a salt.

4. The pharmaceutical composition according to claim 3, wherein the active compound R,R-formoterol is present as a salt with an acid selected from the group consisting of hydrochloric acid, hydrobromic acid, phosphoric acid, nitric acid, sulphuric acid, acetic acid, citric acid, D-gluconic acid, benzoic acid, 2-(4-hydroxybenzoyl) benzoic acid, butyric acid, sulphosalicylic acid, maleic acid, lauric acid, malic acid, fumaric acid, succinic acid, oxalic acid, tartaric acid, embonic acid, stearic acid, toluenesulphonic, methanesulphonic acid and 1-hydroxy-2-naphthoic acid.

5. The pharmaceutical composition according to claim 4, wherein the acid is fumaric acid or tartaric acid.

6. A method of treating an airway disease in a patient comprising administering to a patient in need thereof the pharmaceutical composition according to claim 1 in an administration form suitable for inhalative administration by means of a powder inhaler, wherein the combination is a fixed combination.

7. The method according to claim 6, wherein the active compound ciclesonide is present as its R epimer in an amount greater than 95%.

8. A method of treating an airway disease in a patient comprising administering to a patient in need thereof a therapeutically effective amount of the pharmaceutical composition according to claim 1 by means of a dry powder inhaler.

9. The method according to claim 8, wherein the airway disease is selected from the group consisting of bronchitis, obstructive bronchitis, COPD (chronic obstructive pulmonary disease), spastic bronchitis, allergic bronchitis, allergic asthma and bronchial asthma.

10. The method according to claim 8, wherein ciclesonide or an epimer thereof is administered in a dose of 0.05 to 1 mg per day and R,R-formoterol or a salt thereof is administered in a dose of 10 to 50 μ

g per day.

11. The method according to claim 10, wherein the dose is administered once daily.

12. The pharmaceutical composition according to claim 1, further comprising an excipient and/or vehicle.

13. The pharmaceutical composition according to claim 12, wherein the excipient and/or vehicle is lactose.

14. The pharmaceutical composition according to claim 12, wherein the excipient and/or vehicle is lactose monohydrate.

15. The method according to claim 6, wherein the pharmaceutical composition further comprises an excipient and/or vehicle.

16. The method according to claim 15, wherein the excipient and/or vehicle is lactose.

17. The method according to claim 15, wherein the excipient and/or vehicle is lactose monohydrate.

18. The pharmaceutical composition according to claim 1, wherein the active compounds are administered inhalatively in the form of aerosol particles having a diameter of 0.5 to 10 μ

m.

19. The pharmaceutical composition according to claim 1, wherein the active compounds are administered inhalatively in the form of aerosol particles having a diameter of 2 to 6 μ

m.