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Claims for Patent: 6,686,346

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Claims for Patent: 6,686,346

Title: Formulation
Abstract:A new metered unit dose comprising 40 .mu.g or less of budesonide is disclosed as well as a formulation thereof and the use thereof for the treatment of conditions in the nose.
Inventor(s): Nilsson; Hans (Lund, SE), Santesson; Gordon (Horby, SE)
Assignee: Astra Aktiebolag (Sodertalje, SE)
Application Number:09/933,974
Patent Claims: 1. A unit dose of a therapeutic composition comprising about 32 .mu.g budesonide, wherein the budesonide (a) is in the form of finely divided particles, at least 90% of which have a mass equivalent sphere diameter of less than 20 .mu.m, and (b) is suspended in an aqueous medium, wherein the pH is between 3.5 and 5.0, said composition being suitable for administration to a mammal in a single dose, wherein the composition includes no more than about 32 .mu.g budesonide.

2. The unit dose of claim 1, wherein at least 80% of the particles have a mass equivalent sphere diameter of less than 10 .mu.m.

3. The unit dose of claim 1, wherein at least 80% of the particles have a mass equivalent sphere diameter of less than 7 .mu.m.

4. The unit dose of claim 1, wherein the pH of the aqueous medium is between 4.2 and 4.6.

5. The unit dose of claim 2, wherein the pH of the aqueous medium is between 3.5 and 5.0.

6. The unit dose of claim 2, wherein the pH of the aqueous medium is between 4.2 and 4.6.

7. The unit dose of claim 3, wherein the pH of the aqueous medium is between 3.5 and 5.0.

8. The unit dose of claim 3, wherein the pH of the aqueous medium is between 4.2 and 4.6.

9. The unit dose of claim 1, wherein said composition is suitable for nasal administration to a mammal.

10. The unit dose of claim 1, wherein the composition contains about 0.6 to 0.7 mg/ml budesonide.

11. The unit dose of claim 1, further comprising one or more pharmaceutically acceptable additives selected from the group consisting of thickening agents, isotonicity agents, surfactants, chelating agents, and preservatives.

12. A therapeutic method of treating or preventing seasonal allergic rhinitis, perennial allergic rhinitis, non-allergic rhinitis, nasal polyps, chronic sinusitis, or recurrent sinusitis, the method comprising administering into a nostril of a mammal in need thereof a metered unit dose of finely divided budesonide particles, at least 90% having a mass equivalent sphere diameter of less than 20 .mu.m, the particles being suspended in an aqueous medium, wherein said metered unit dose consists of about 32 .mu.g budesonide and one or more ingredients other than budesonide.

13. The therapeutic method of claim 12, wherein at least 80% of the particles have a mass equivalent sphere diameter of less than 10 .mu.m.

14. The therapeutic method of claim 12, wherein at least 80% of the particles have a mass equivalent sphere diameter of less than 7 .mu.m.

15. The therapeutic method of claim 12, wherein the condition to be treated is seasonal allergic rhinitis.

16. The therapeutic method of claim 12, wherein the condition to be treated is perennial allergic rhinitis.

17. The therapeutic method of claim 12, wherein the condition to be treated is perennial non-allergic rhinitis.

18. The therapeutic method of claim 12, wherein the condition to be treated is chronic sinusitis.

19. The therapeutic method of claim 12, wherein the condition to be treated is recurrent sinusitis.

20. The therapeutic method of claim 12, wherein the condition to be treated is nasal polyps.

21. The therapeutic method of claim 12, wherein the unit dose contains about 0.6 to 0.7 mg/ml budesonide.

22. A unit dose of a therapeutic composition, the active ingredient of which consists of about 32 .mu.g budesonide formulated as finely divided particles, at least 90% of which have a mass equivalent sphere diameter of less than 20 .mu.m, suspended in an aqueous medium, wherein the pH is between 3.5 and 5.0, said composition being suitable for administration to a mammal in a single dose.

23. The unit dose of claim 22, wherein at least 80% of the particles have a mass equivalent sphere diameter of less than 10 .mu.m.

24. The unit dose of claim 22, wherein at least 80% of the particles have a mass equivalent sphere diameter of less than 7 .mu.m.

25. The unit dose of claim 22, wherein the composition contains about 0.6 to 0.7 mg/ml budesonide.

26. A container containing budesonide and adapted to deliver the unit dose of claim 1.

27. A container containing budesonide and adapted to deliver the unit dose of claim 2.

28. A container containing budesonide and adapted to deliver the unit dose of claim 3.

29. The unit dose of claim 22, wherein the pH of the aqueous medium is between 4.2 and 4.6.
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