Combination of methylxanthine compounds and steroids to treat chronic respiratory diseases

• US 8,431,553 B2
• Filed: 02/13/2006
• Issued: 04/30/2013
• Est. Priority Date: 02/11/2005
• Status: Expired due to Fees

• Current Assignee: Pulmagen Therapeutics (Inflammation) Limited (Galapagos NV)
• Original Assignee: Pulmagen Therapeutics (Inflammation) Limited (Galapagos NV)
• Inventors: Fox, Justian Craig, Fitzgerald, Mary Frances, Finch, Harry
• Primary Examiner(s): SZNAIDMAN, MARCOS L
• Application Number:
  US11/883,635
• Publication Number:
  US 20080318913A1
• Time in Patent Office: 2,633 Days
• Field of Search: 514/171
• US Class Current: 514/171
• 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 31/52 Purines, e.g. adenine
• CPC Class Codes: A61K 31/58 containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin digitoxin A61K31/7048
• 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
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

There is provided the use of a methylxanthine derivative such as theophylline and a steroid in a synergistic combination for the treatment of chronic obstructive pulmonary disease, wherein the combination is administered by the inhaled route for pulmonary delivery.

Claims

1. A pharmaceutical composition comprising an amount of theophylline and a corticosteroid effective for the treatment of chronic obstructive pulmonary disease (COPD), wherein (i) the pharmaceutical composition is adapted for administration by the inhaled route for pulmonary delivery, and (ii) the amount of theophylline is between 0.033 mg and 25 mg.

2. A composition according to claim 1 wherein the corticosteroid is budesonide and is provided in an amount from 200 mcg to 1600 mcg per unit dose of the composition, said unit dose corresponding to once per day treatment.

3. A composition according to claim 1 wherein the corticosteroid is fluticasone and is provided in an amount from 44 mcg and 1000 mcg per unit dose of the composition, said unit dose corresponding to once per day treatment.

4. A composition according to claim 1 wherein the corticosteroid is ciclesonide and is provided in an amount from 40 mcg and 500 mcg per unit dose of the composition, said unit dose corresponding to once per day treatment.

10. A composition according to claim 1 wherein the corticosteroid is budesonide and is provided in an amount from 100 mcg to 800 mcg per unit dose of the composition, said unit dose corresponding to twice per day treatment.

11. A composition according to claim 1 wherein the corticosteroid is budesonide and is provided in an amount from 65 mcg to 525 mcg per unit dose of the composition, said unit dose corresponding to three times per day treatment.

12. A composition according to claim 1 wherein the corticosteroid is fluticasone and is provided in an amount from 22 mcg to 500 mcg per unit dose of the composition, said unit dose corresponding to twice per day treatment.

13. A composition according to claim 1 wherein the corticosteroid is fluticasone and is provided in an amount from 11 mcg to 335 mcg per unit dose of the composition, said unit dose corresponding to three times per day treatment.

14. A composition according to claim 1 wherein the corticosteroid is ciclesonide and is provided in an amount from 20 mcg to 250 mcg per unit dose of the composition, said unit dose corresponding to twice per day treatment.

15. A composition according to claim 1 wherein the corticosteroid is ciclesonide and is provided in an amount from 14 mcg to 170 mcg per unit dose of the composition, said unit dose corresponding to three times per day treatment.

22. A composition according to claim 1 wherein the amount of theophylline is between 0.05 mg and 12.5 mg.

23. A composition according to claim 1 wherein the amount of theophylline is between 0.033 mg and 8 mg.

5. A kit comprising an amount of theophylline and a corticosteroid effective for the treatment of chronic obstructive pulmonary disease (COPD) in unit dosage form adapted for administration by the inhaled route for pulmonary delivery wherein the theophylline is present in an amount between 0.033 mg and 25 mg.

6. A kit according to claim 5 wherein the corticosteroid is budesonide and is provided in an amount from 200 mcg to 1600 mcg per unit dose of the composition, said unit dose corresponding to once per day treatment.

7. A kit according to claim 5, said kit being in the form of an inhaler.

8. A kit according to claim 5 wherein the corticosteroid is fluticasone and is provided in an amount from 44 mcg and 1000 mcg per unit dose of the composition, said unit dose corresponding to once per day treatment.

9. A kit according to claim 5 wherein the corticosteroid is ciclesonide and is provided in an amount from 40 mcg and 500 mcg per unit dose of the composition, said unit dose corresponding to once per day treatment.

16. A kit according to claim 5 wherein the corticosteroid is budesonide and is provided in an amount from 100 mcg to 800 mcg per unit dose of the composition, said unit dose corresponding to twice per day treatment.

17. A kit according to claim 5 wherein the corticosteroid is budesonide and is provided in an amount from 65 mcg to 525 mcg per unit dose of the composition, said unit dose corresponding to three times per day treatment.

18. A kit according to claim 5 wherein the corticosteroid is fluticasone and is provided in an amount from 22 mcg to 500 mcg per unit dose of the composition, said unit dose corresponding to twice per day treatment.

19. A kit according to claim 5 wherein the corticosteroid is fluticasone and is provided in an amount from 11 mcg to 335 mcg per unit dose of the composition, said unit dose corresponding to three times per day treatment.

20. A kit according to claim 5 wherein the corticosteroid is ciclesonide and is provided in an amount from 20 mcg to 250 mcg per unit dose of the composition, said unit dose corresponding to twice per day treatment.

21. A kit according to claim 5 wherein the corticosteroid is ciclesonide and is provided in an amount from 14 mcg to 170 mcg per unit dose of the composition, said unit dose corresponding to three times per day treatment.