Salt of (S)-pantoprazole and its hydrates
View Patent ↗The invention relates to (−)-pantoprazole magnesium and its hydrates and to medicaments comprising these compounds.
1. (−)-Pantoprazole magnesium [(S)-pantoprazole magnesium] dihydrate, wherein (−)-pantoprazole magnesium is substantially free of the (+)-enantiomer.
2. A (−)-pantoprazole magnesium dihydrate according to claim 1 , having a water content of from about 4.0 to about 5.0%.
3. A (−)-pantoprazole magnesium dihydrate according to claim 1 , having a water content of from about 4.2 to about 4.6%.
4. A (−)-pantoprazole magnesium dihydrate according to claim 1 with a particle size distribution of 99% below 100 μm.
5. A (−)-pantoprazole magnesium dihydrate according to claim 1 with X-ray powder diffraction patterns which are characterized by reflections with strong (2φ about 23°), medium (2φ about 6°, 12°, 14°, 17°, 19°, 22°, 24°, 25°, 30°, 33° and 35°) and small (2φ about 13°, 16°, 26°, 28°, 33° and in the range of 36° and 62°) intensities.
6. A pharmaceutical composition comprising (−)-pantoprazole magnesium dihydrate, wherein (−)-pantoprazole magnesium is substantially free of the (+)-enantiomer, together with a suitable pharmaceutical auxiliary or carrier.
7. A pharmaceutical composition comprising (−)-pantoprazole magnesium dihydrate, wherein (−)-pantoprazole magnesium is substantially free of the (+)-enantiomer, together with a suitable pharmaceutical auxiliary or carrier, wherein (−)-pantoprazole is present in an amount from about 10 to about 100 mg.
8. A method of treating a gastrointestinal disorder in a patient comprising administering to a patient in need thereof a therapeutically effective amount of (−)-pantoprazole magnesium dihydrate, wherein (−)-pantoprazole magnesium is substantially free of the (+)-enantiomer and wherein the patient needs an inhibition of acid secretion for an extended period of time.
9. A (−)-pantoprazole magnesium dihydrate according to claim 2 with a particle size distribution of 99% below 100 μm.
10. A (−)-pantoprazole magnesium dihydrate according to claim 3 with a particle size distribution of 99% below 100 μm.
11. A (−)-pantoprazole magnesium dihydrate according to claim 2 with X-ray powder diffraction patterns which are characterized by reflections with strong (2φ about 23°), medium (2φ about 6°, 12°, 14°, 17°, 19°, 22°, 24°, 25°, 30°, 33° and 35°) and small (2φ about 13°, 16°, 26°, 28°, 33° and in the range of 36° and 62°) intensities.
12. A (−)-pantoprazole magnesium dihydrate according to claim 3 with X-ray powder diffraction patterns which are characterized by reflections with strong (2φ about 23°), medium (2φ about 6°, 12°, 14°, 17°, 19°, 22°, 24°, 25°, 30°, 33° and 35°) and small (20φ about 13°, 16°, 26°, 28°, 33° and in the range of 36° and 62°) intensities.
13. A pharmaceutical composition comprising a (−)-pantoprazole magnesium dihydrate according to claim 2 together with a suitable pharmaceutical auxiliary or carrier.
14. A pharmaceutical composition comprising a (−)-pantoprazole magnesium dihydrate according to claim 2 together with a suitable pharmaceutical auxiliary or carrier, wherein (−)-pantoprazole is present in an amount from about 10 to about 100 mg.
15. A pharmaceutical composition comprising a (−)-pantoprazole magnesium dihydrate according to claim 3 together with a suitable pharmaceutical auxiliary or carrier.
16. A pharmaceutical composition comprising a (−)-pantoprazole magnesium dihydrate according to claim 3 together with a suitable pharmaceutical auxiliary or carrier, wherein (−)-pantoprazole is present in an amount from about 10 to about 100 mg.
17. A pharmaceutical composition comprising a (−)-pantoprazole magnesium dihydrate according to claim 4 together with a suitable pharmaceutical auxiliary or carrier.
18. A pharmaceutical composition comprising a (−)-pantoprazole magnesium dihydrate according to claim 4 together with a suitable pharmaceutical auxiliary or carrier, wherein (−)-pantoprazole is present in an amount from about 10 to about 100 mg.
19. A pharmaceutical composition comprising a (−)-pantoprazole magnesium dihydrate according to claim 5 together with a suitable pharmaceutical auxiliary or carrier.
20. A pharmaceutical composition comprising a (−)-pantoprazole magnesium dihydrate according to claim 5 together with a suitable pharmaceutical auxiliary or carrier, wherein (−)-pantoprazole is present in an amount from about 10 to about 100 mg.