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Last Updated: January 26, 2021

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Claims for Patent: 8,252,813

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Summary for Patent: 8,252,813
Title:Salt and crystalline forms thereof of a drug
Abstract: A crystalline form of a drug, ways to make it, compositions containing it and methods of treatment of diseases and inhibition of adverse physiological events using it are disclosed.
Inventor(s): Zhang; Geoff G. Z. (Libertyville, IL), Bradley; Michael F. (Covington, WA), Barnes; David M. (Lake Villa, IL), Henry; Rodger (Wildwood, IL)
Assignee: Abbott Laboratories (Abbott Park, IL)
Application Number:12/701,254
Patent Claims: 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-h- ydroxyazetidin-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.degree. C. with Cu--K.alpha. 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 .ANG., 21.4010 .ANG., and 5.3050 .ANG. and .beta. of about 109.degree. in the monoclinic crystal system P 21/C or P 21/M space group, when measured with Mo--K.alpha. radiation at about 25.degree. 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-h- ydroxyazetidin-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-h- ydroxyazetidin-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.degree. C. with Cu--K.alpha. 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 .ANG., 29.9840 .ANG., and 12.5070 .ANG. and .beta. of about 105.degree. in the monoclinic crystal system P 21/C or P 21/M space group, when measured with Mo--K.alpha. radiation at about 25.degree. 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-h- ydroxyazetidin-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-h- ydroxyazetidin-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-h- ydroxyazetidin-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-h- ydroxyazetidin-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--K.alpha. radiation at about 25.degree. C., by respective lattice parameters, a, b, and c of about 16.4460 .ANG., 21.4010 .ANG., and 5.3050 .ANG. and .beta. of about 109.degree..

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-h- ydroxyazetidin-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--K.alpha. radiation at about 25.degree. C., by respective lattice parameters, a, b, and c of about 8.2490 .ANG., 29.9840 .ANG., and 12.5070 .ANG. and .beta. of about 105.degree..

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