Salt and crystalline forms thereof of a drug

1. A therapeutic composition comprising D-Glucitol, 1-deoxy-1-(methylamino)-, 1-(6-amino-3,5-difluoropyridin-2-yl)-8-chloro-6-fluoro-1,4-dihydro-7-(3-hydroxyazetidin-1-yl)-4-oxo-3-quinolinecarboxylate salt and an excipient.

2. The composition of claim 1 , wherein the salt is present in a therapeutically acceptable amount.

3. The composition of claim 1 , wherein the salt is crystalline.

4. The composition of claim 3 , wherein the salt has substantially crystalline purity.

5. The composition of claim 4 , wherein the salt has at least about 95% crystalline purity.

6. The composition of claim 3 , wherein the salt is characterized, when measured at about 25° C. with Cu—Kα radiation, by the powder diffraction pattern shown in FIG. 1 .

7. The composition of claim 3 , wherein the salt is characterized by respective lattice parameters, a, b, and c of about 16.4460 Å, 21.4010 Å, and 5.3050 Å and β of about 109° in the monoclinic crystal system P 21/C or P 21/M space group, when measured with Mo—Kα radiation at about 25° C.

8. The composition of claim 1 , wherein the salt has substantial chemical purity.

9. The composition of claim 8 , wherein the salt is about 97% chemically pure.

10. The composition of claim 8 , wherein the salt is about 98% chemically pure.

11. The composition of claim 8 , wherein the salt is about 100% chemically pure.

12. The composition of claim 1 , wherein the composition is an orally administered dosage form.

13. The composition of claim 1 , wherein the composition is a parenterally administered dosage form.

14. A therapeutic composition comprising D-Glucitol, 1-deoxy-1-(methylamino)-, 1-(6-amino-3,5-difluoropyridin-2-yl)-8-chloro-6-fluoro-1,4-dihydro-7-(3-hydroxyazetidin-1-yl)-4-oxo-3-quinolinecarboxylate salt, providone, cellulose, and magnesium stearate, wherein the composition is a solid dosage form for oral administration.

15. The composition of claim 14 , wherein the salt is present in a therapeutically acceptable amount.

16. A therapeutic composition comprising D-Glucitol, 1-deoxy-1-(methylamino)-, 1-(6-amino-3,5-difluoropyridin-2-yl)-8-chloro-6-fluoro-1,4-dihydro-7-(3-hydroxyazetidin-1-yl)-4-oxo-3-quinolinecarboxylate trihydrate salt and an excipient.

17. The composition of claim 16 , wherein the salt is present in a therapeutically acceptable amount.

18. The composition of claim 16 , wherein the salt is crystalline.

19. The composition of claim 18 , wherein the salt has substantial crystalline purity.

20. The composition of claim 19 , wherein the salt has at least about 95% crystalline purity.

21. The composition of claim 18 , wherein the salt is characterized, when measured at about 25° C. with Cu—Kα radiation, by the powder diffraction pattern shown in FIG. 2 .

22. The composition of claim 18 , wherein the salt is characterized by respective lattice parameters, a, b, and c of about 8.2490 Å, 29.9840 Å, and 12.5070 Å and β of about 105° in the monoclinic crystal system P 21/C or P 21/M space group, when measured with Mo—Kα radiation at about 25° C.

23. The composition of claim 16 , wherein the salt has substantial chemical purity.

24. The composition of claim 23 , wherein the salt is about 97% chemically pure.

25. The composition of claim 23 , wherein the salt is about 98% chemically pure.

26. The composition of claim 23 , wherein the salt is about 100% chemically pure.

27. The composition of claim 16 , wherein the composition is an orally administered dosage form.

28. The composition of claim 16 , wherein the composition is a parenterally administered dosage form.

29. A therapeutic composition comprising D-Glucitol, 1-deoxy-1-(methylamino)-, 1-(6-amino-3,5-difluoropyridin-2-yl)-8-chloro-6-fluoro-1,4-dihydro-7-(3-hydroxyazetidin-1-yl)-4-oxo-3-quinolinecarboxylate trihydrate salt, providone, cellulose, and magnesium stearate, wherein the composition is a solid dosage form for oral administration.

30. The composition of claim 29 , wherein the salt is present in a therapeutically acceptable amount.

31. A method of treating a bacterial infection in a fish or a mammal comprising administering thereto a composition comprising a therapeutically acceptable amount of D-Glucitol, 1-deoxy-1-(methylamino)-, 1-(6-amino-3,5-difluoropyridin-2-yl)-8-chloro-6-fluoro-1,4-dihydro-7-(3-hydroxyazetidin-1-yl)-4-oxo-3-quinolinecarboxylate salt and an excipient.

32. The method of claim 31 , wherein the salt is administered to a mammal.

33. The method of claim 31 , wherein the therapeutically acceptable amount is from about 0.03 to about 200 mg/Kg body weight.

34. A method of treating a bacterial infection in a fish or a mammal comprising administering thereto a composition comprising a therapeutically acceptable amount of D-Glucitol, 1-deoxy-1-(methylamino)-, 1-(6-amino-3,5-difluoropyridin-2-yl)-8-chloro-6-fluoro-1,4-dihydro-7-(3-hydroxyazetidin-1-yl)-4-oxo-3-quinolinecarboxylate trihydrate salt and an excipient.

35. The method of claim 34 , wherein the salt is administered to a mammal.

36. The method of claim 34 , wherein the therapeutically acceptable amount is from about 0.03 to about 200 mg/Kg body weight.

37. Crystalline D-Glucitol, 1-deoxy-1-(methylamino)-, 1-(6-amino-3,5-difluoropyridin-2-yl)-8-chloro-6-fluoro-1,4-dihydro-7-(3-hydroxyazetidin-1-yl)-4-oxo-3-quinolinecarboxylate salt characterized, in the monoclinic crystal system P 21/C or P 21/M space group, when measured with Mo—Kα radiation at about 25° C., by respective lattice parameters, a, b, and c of about 16.4460 Å, 21.4010 Å, and 5.3050 Å and β of about 109°.

38. Crystalline D-Glucitol, 1-deoxy-1-(methylamino)-, 1-(6-amino-3,5-difluoropyridin-2-yl)-8-chloro-6-fluoro-1,4-dihydro-7-(3-hydroxyazetidin-1-yl)-4-oxo-3-quinolinecarboxylate trihydrate salt characterized, in the monoclinic crystal system P 21/C or P 21/M space group, when measured with Mo—Kα radiation at about 25° C., by respective lattice parameters, a, b, and c of about 8.2490 Å, 29.9840 Å, and 12.5070 Å and β of about 105°.