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Claims for Patent: 7,351,723

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Claims for Patent: 7,351,723

Title:Freeze-dried pantoprazole preparation and pantoprazole injection
Abstract:Lyophilized pantoprazole preparations which are obtainable by freeze-drying of an aqueous solution of pantoprazole, ethylenediamine tetraacetic acid and/or a suitable salt thereof, and sodium hydroxide and/or sodium carbonate are disclosed. The preparations have advantageous properties when reconstituted for injection.
Inventor(s): Linder; Rudolf (Constance, DE), Dietrich; Rango (Constance, DE)
Assignee: Nycomed GmbH (Constance, DE)
Application Number:10/855,703
Patent Claims: 1. Lyophilized preparation consisting of: (a) 5-difluoromethoxy-2-[(3,4-dimethoxy-2-pyridinyl)methylsulfinyl]-1H-benzim- idazole (pantoprazole) or a solvate, hydrate, salt, hydrate of a salt or solvate of a salt thereof; (b) ethylenediamine tetraacetic acid and/or a suitable salt thereof, and (c) sodium hydroxide and/or sodium carbonate.

2. The preparation according to claim 1, wherein the pantoprazole is pantoprazole sodium.

3. The preparation according to claim 1, wherein the pantoprazole is pantoprazole sodium sesquihydrate.

4. The preparation according to claim 1, wherein the pantoprazole is pantoprazole magnesium.

5. The preparation according to claim 1, wherein the pantoprazole is pantoprazole magnesium dihydrate.

6. The preparation according to claim 1, wherein the pantoprazole is (-)-pantoprazole or a solvate, hydrate, salt, hydrate of a salt or solvate of a salt thereof.

7. The preparation according to claim 1, wherein the ethylenediamine tetraacetic acid is present as ethylenediamine tetraacetic acid disodium salt.

8. The preparation according to claim 2, wherein the ethylenediamine tetraacetic acid is present as ethylenediamine tetraacetic acid disodium salt.

9. The preparation according to claim 3, wherein the ethylenediamine tetraacetic acid is present as ethylenediamine tetraacetic acid disodium salt.

10. The preparation according to claim 4, wherein the ethylenediamine tetraacetic acid is present as ethylenediamine tetraacetic acid disodium salt.

11. The preparation according to claim 5, wherein the ethylenediamine tetraacetic acid is present as ethylenediamine tetraacetic acid disodium salt.

12. The preparation according to claim 6, wherein the ethylenediamine tetraacetic acid is present as ethylenediamine tetraacetic acid disodium salt.

13. The preparation according to claim 1, consisting of (a) Pantoprazole sodium; (b) ethylenediamine tetraacetic acid disodium salt; and (c) sodium hydroxide.

14. The preparation according to claim 1 consisting of: (a) Pantoprazole sodium sesquihydrate; (b) ethylenediamine tetraacetic acid disodium salt; and (c) sodium hydroxide.
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