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Claims for Patent: 8,754,108

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Claims for Patent: 8,754,108

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: Takeda, GmbH (Constance, DE)
Application Number:12/010,124
Patent Claims: 1. A pantoprazole injectable solution for bolus administration obtainable by reconstitution consisting of: (a) a lyophilized preparation consisting of: i. 5-difluoromethoxy-2-[(3,4-dimethoxy-2-pyridinyl)methylsulfinyl]-1H- -benzimidazole (pantoprazole) or a solvate, hydrate, salt, hydrate of a salt or solvate of a salt thereof; ii. ethylenediamine tetraacetic acid and/or a suitable salt thereof, and iii. sodium hydroxide and/or sodium carbonate; and (b) an aqueous solvent selected from the group consisting of physiological saline, an aqueous solution of 5% glucose and distilled water.

2. The pantoprazole injectable solution according to claim 1, wherein the solvent is physiological saline.

3. The pantoprazole injectable solution according to claim 1, wherein the pantoprazole is pantoprazole sodium.

4. The pantoprazole injectable solution according to claim 1, wherein the pantoprazole is pantoprazole sodium sesquihydrate.

5. The pantoprazole injectable solution according to claim 1, wherein the pantoprazole is pantoprazole magnesium.

6. The pantoprazole injectable solution according to claim 1, wherein the pantoprazole is pantoprazole magnesium dihydrate.

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

8. The pantoprazole injectable solution according to claim 1, wherein the ethylenediamine tetraacetic acid is present as ethylenediamine tetraacetic acid disodium salt.

9. The pantoprazole injectable solution according to claim 2, wherein the ethylenediamine tetraacetic acid is present as ethylenediamine tetraacetic acid disodium salt.

10. The pantoprazole injectable solution according to claim 3, wherein the ethylenediamine tetraacetic acid is present as ethylenediamine tetraacetic acid disodium salt.

11. The pantoprazole injectable solution according to claim 4, wherein the ethylenediamine tetraacetic acid is present as ethylenediamine tetraacetic acid disodium salt.

12. The pantoprazole injectable solution according to claim 5, wherein the ethylenediamine tetraacetic acid is present as ethylenediamine tetraacetic acid disodium salt.

13. The pantoprazole injectable solution according to claim 6, wherein the ethylenediamine tetraacetic acid is present as ethylenediamine tetraacetic acid disodium salt.

14. The pantoprazole injectable solution according to claim 7, wherein the ethylenediamine tetraacetic acid is present as ethylenediamine tetraacetic acid disodium salt.

15. The pantoprazole injectable solution according to claim 1, wherein the lyophilized preparation consists of (a) Pantoprazole sodium; (b) ethylenediamine tetraacetic acid disodium salt; and (c) sodium hydroxide.

16. The pantoprazole injectable solution according to claim 1, wherein the lyophilized preparation consists of (a) Pantoprazole sodium sesquihydrate; (b) ethylenediamine tetraacetic acid disodium salt; and (c) sodium hydroxide.
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