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Claims for Patent: 6,291,445

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Claims for Patent: 6,291,445

Title: Low dose budesonide formulations and uses thereof
Abstract:A metered unit dose comprising 40 .mu.g or less of budesonide is disclosed, as well as formulations thereof, and the use thereof for the treatment of nasal conditions.
Inventor(s): Nilsson; Hans (Lund, SE), Santesson; Gordon (Horby, SE)
Assignee: Astra Aktiebolag (Sodertalje, SE)
Application Number:08/846,960
Patent Claims: 1. A unit dose of a therapeutic composition comprising about 32 .mu.g budesonide, wherein the budesonide is in the form of finely divided particles and is suspended in an aqueous medium, 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, further comprising one or more pharmaceutically acceptable additives selected from the group consisting of thickening agents, isotonicity agents, surfactants, chelating agents, and preservatives.

3. The unit dose of claim 1, wherein the mass equivalent sphere diameter of the budesonide particles is 10 .mu.m or less.

4. A container containing budesonide and adapted to deliver a unit dose according to claim 1.

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

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

7. A therapeutic method of treating or preventing conditions of the upper respiratory tract, the method comprising administering into a nostril of a mammal a metered unit dose of finely divided budesonide particles 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.

8. A method according to claim 7, in which the condition to be treated is selected from the group consisting of seasonal allergic rhinitis, perennial allergic rhinitis, perennial non-allergic rhinitis, chronic sinusitis, recurrent sinusitis and nasal polyps.

9. A therapeutic method according to claim 7, wherein the condition to be treated is seasonal allergic rhinitis.

10. A therapeutic method according to claim 7, wherein the condition to be treated is perennial allergic rhinitis.

11. A therapeutic method according to claim 7, wherein the condition to be treated is perennial non-allergic rhinitis.

12. A therapeutic method according to claim 7, wherein the condition to be treated is chronic sinusitis.

13. A therapeutic method according to claim 7, wherein the condition to be treated is recurrent sinusitis.

14. A therapeutic method according to claim 7, wherein the condition to be treated is nasal polyps.

15. The method of claim 7, wherein the unit dose contains about 0.6 to 0.7 mg/ml budesonide.

16. A therapeutic method of treating conditions of the upper respiratory tract, the method comprising metering into the nose of a mammal a therapeutically effective amount of budesonide that is less than about 320 .mu.g per day, delivered as 8 or more unit doses, wherein each unit dose comprises finely divided budesonide particles suspended in an aqueous medium in a metered amount of about 32 .mu.g budesonide.

17. A therapeutic method according to claim 16, wherein the amount of budesonide is about 256 .mu.g per day.

18. The method of claim 16, wherein each unit dose contains about 0.6 to 0.7 mg/ml budesonide.

19. A unit dose of a therapeutic composition consisting of:

about 32 1 .mu.g budesonide; and

other ingredients comprising

a composition consisting of microcrystalline cellulose and sodium carboxymethyl cellulose, the composition at about 0.5 to 2.5% by weight of the therapeutic composition;

dextrose;

Polysorbate 80 at about 0.005 to 0.5% by weight of the therapeutic composition;

disodium edetate at about 0.005 to 0.1% by weight of the therapeutic composition; and

potassium sorbate at about 0.05 to 0.2% by weight of the therapeutic composition,

wherein the budesonide is in the form of finely divided particles suspended in an aqueous medium, said therapeutic composition being suitable for nasal administration to a mammal in a single dose.

20. A therapeutic method of treating conditions of the upper respiratory tract, the method comprising metering into the nose of a mammal a therapeutically effective amount of budesonide that is less than about 320 .mu.g per day, delivered as 8 or more unit doses, wherein each unit dose consists of about 32 .mu.g budesonide and other ingredients, the other ingredients comprising

a composition consisting of microcrystalline cellulose and sodium carboxymethyl cellulose, the composition at about 0.5 to 2.5% by weight of the therapeutic composition;

dextrose;

Polysorbate 80 at about 0.005 to 0.5% by weight of the therapeutic composition;

disodium edetate at about 0.005 to 0.1% by weight of the therapeutic composition; and

potassium sorbate at about 0.05 to 0.2% by weight of the therapeutic composition,

wherein the budesonide is in the form of finely divided particles suspended in an aqueous medium.

21. The method of claim 20, wherein each 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 suspended in an aqueous medium, said camposition being suitable for administration to a mammal in a single dose.

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

24. A therapeutic method of treating or preventing conditions of the upper respiratory tract, the method comprising administering into a nostril of a mammal a metered unit dose, the active ingredient of which consists of about 32 .mu.g of budesonide formulated as finely divided particle s suspended in an aqueous medium.

25. The method of claim 24, wherein the unit dose contains about 0.6 to 0.7 mg/ml budesonide.

26. A therapeutic method of treating conditions of the upper respiratory tract, the method comprising metering into the nose of a mammal a therapeutically effective amount of budesonide that is less than about 320 .mu.g per day, delivered as 8 or more unit doses, the active ingredient of each unit dose consisting of about 32 .mu.g budesonide formulated as finely divided particle suspended in an aqueous medium.

27. The method of claim 26, wherein each unit dose contains about 0.6 to 0.7 mg/ml budesonide.

28. A unit dose of a therapeutic composition, the active ingredient of which consists of about 32 .mu.g budesonide, wherein the therapeutic composition additionally comprises

a composition consisting of microcrystalline cellulose and sodium carboxymethyl cellulose, the composition at about 0.5 to 2.5% by weight of the therapeutic composition;

dextrose;

Polysorbate 80 at about 0.005 to 0.5% by weight of the therapeutic composition;

disodium edetate at about 0.005 to 0.1% by weight of the therapeutic composition; and

potassium sorbate at about 0.05 to 0.2% by weight of the therapeutic composition, and

wherein the budesonide is in the, form of finely divided particles suspended in an aqueous medium, said therapeutic composition being suitable for nasal administration to a mammal in a single dose.

29. The method of claim 28, wherein each unit dose contains about 0.6 to 0.7 mg/ml budesonide.
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