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Claims for Patent: 5,914,122

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Claims for Patent: 5,914,122

Title: Stable budesonide solutions, method of preparing them and use of these solutions as enema preparations and pharmaceutical foams
Abstract:A stable budesonide solution with a pH not exceeding 6.0 in which the budesonide is dissolved in a solvent which may be water, an alcohol such as ethanol, isopropanol or propylene glycol, or a water/alcohol mixture. The solution preferably also contains a stabilizer such as sodium ethylenediaminetetraacetic acid, cyclodextrins or mixtures thereof. The stable budesonide solution is useful as the active ingredient in a rectal enema or a rectal foam.
Inventor(s): Otterbeck; Norbert (Uberlingen, DE), Kuhn; Reimund (Freiamt, DE)
Assignee: Dr. Falk Pharma GmbH (Freiburg, DE)
Application Number:08/860,136
Patent Claims: 1. A stable budesonide solution with a pH not exceeding 6.0 in which the budesonide is dissolved in a solvent selected from the group consisting of water, alcohol and a water/alcohol mixture and wherein the alcohol is selected from the group consisting of ethanol, isopropanol and propylene glycol.

2. A stable budesonide solution as in claim 1, which comprises a stabilizing additive selected from the group consisting of sodium ethylenediaminetetraacetic acid, cyclodextrins and mixtures thereof.

3. A stable budesonide solution with a pH not exceeding 6.0 in which the budesonide is dissolved in a solvent selected from the group consisting of water, alcohol and a water/alcohol mixture and wherein the alcohol is selected from the group consisting of ethanol, isopropanol and propylene glycol, which comprises 0.001 to 0.1% by weight of budesonide.

4. A stable budesonide solution with a pH not exceeding 6.0 in which the budesonide is dissolved in a solvent selected from the group consisting of water, alcohol and a water/alcohol mixture and wherein the alcohol is selected from the group consisting of ethanol, isopropanol and propylene glycol, further comprising 0.05 to 1.0% by weight of cyclodextrins.

5. A stable budesonide solution as in claim 1, with a pH not exceeding 6.0 comprising 0.001 to 0.1% by weight of budesonide and stabilizing additives selected from the group consisting of 0.001 to 0.1% by weight of sodium ethylenediaminetetraacetic acid; 0.05 to 1.0% by weight of cyclodextrins and a mixture of said amounts of sodium ethylenediaminetetraacetic acid and cyclodextrins.

6. A process for producing a stable budesonide-containing solution with a pH not exceeding 6.0 which comprises dissolving the budesonide in a solvent selected from the group consisting of water, alcohol and a water/alcohol mixture, with the alcohol selected from the group consisting of ethanol, isopropanol and propylene glycol, and adjusting the pH of the budesonide solution to a value not exceeding 6.0.

7. A process as in claim 6, which comprises adding thereto a stabilizing additive selected from the group consisting of sodium ethylenediaminetetraacetic, cyclodextrins and a mixture thereof.

8. A process as in claim 6, wherein the solution comprises 0.001 to 1% by weight of budesonide and the stabilizing additive is selected from the group consisting of 0.001 to 1% by weight of sodium ethylenediaminetetraacetic acid, 0.05 to 1.0% by weight of cyclodextrins and a mixture of said amounts of sodium ethylenediaminetetraaceticacetic acid and cyclodextrins.

9. An enema solution which comprises as the active ingredient, a stable budesonide solution as in claim 1.

10. An enema solution which comprises as the active ingredient, a stable budesonide solution as in claim 2.

11. An enema solution which comprises as the active ingredient, a stable budesonide solution as in claim 3.

12. An enema solution which comprises as the active ingredient, a stable budesonide solution as in claim 4.

13. An enema solution which comprises as the active ingredient, a stable budesonide solution as in claim 5.

14. An enema solution which comprises as the active ingredient, stable budesonide solution as in claim 6.

15. A rectal foam which comprises, as the active ingredient, a stable aqueous budesonide solution as in claim 1.

16. A rectal foam which comprises as the active ingredient, a stable budesonide solution as in claim 2.

17. A rectal foam which comprises as the active ingredient, a stable budesonide solution as in claim 3.

18. A rectal foam which comprises as the active ingredient, a stable budesonide solution as in claim 4.

19. A rectal foam which comprises as the active ingredient, a stable budesonide solution as in claim 5.

20. A rectal foam which comprises as the active ingredient, a stable budesonide solution as in claim 6.

21. A stable budesonide solution with a pH not exceeding 6.0 in which the budesonide is dissolved in a solvent selected from the group consisting of water, alcohol and a water/alcohol mixture and wherein the alcohol is selected from the group consisting of ethanol, isopropanol and propylene glycol, further comprising 0.001 to 0.1% by weight of sodium ethylenediaminetetraacetic acid.

22. A stable budesonide solution with a pH not exceeding 6.0 in which the budesonide is dissolved in a solvent selected from the group consisting of water, alcohol and a water/alcohol mixture and wherein the alcohol is selected from the group consisting of ethanol, isopropanol and propylene glycol, comprising 0.001 to 0.1% by weight of budesonide and stabilizing additives selected from the group consisting of 0.001 to 0.1% by weight of sodium ethylene-diaminetetraacetic acid, 0.05 to 1.0% by weight of cyclodextrins and a mixture of said amounts of sodium ethylene-diaminetetraacetic acid and cyclodextrins.
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