Freeze-dried pantoprazole preparation and pantoprazole injection
View Patent ↗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.
1. Lyophilized preparation consisting of:
(a) 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;
(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.