Claims for Patent: 8,648,093

Summary for Patent: 8,648,093

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:	Abbvie Inc. (North Chicago, IL)
Application Number:	13/595,585
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 selected from the group consisting of agar, alginic acid, aluminum hydroxide, benzyl alcohol, benzyl benzoate, 1,3-butylene glycol, carbomers, castor oil, cellulose, cellulose acetate, cocoa butter, corn starch, corn oil, cottonseed oil, cross-povidone, diglycerides, ethanol, ethyl cellulose, ethyl laureate, ethyl oleate, fatty acid esters, gelatin, germ oil, glucose, glycerol, groundnut oil, hydroxypropylmethyl cellulose, isopropanol, isotonic saline, lactose, magnesium hydroxide, magnesium stearate, malt, mannitol, monoglycerides, olive oil, peanut oil, potassium phosphate salts, potato starch, povidone, propylene glycol, Ringer's solution, safflower oil, sesame oil, sodium carboxymethyl cellulose, sodium phosphate salts, sodium lauryl sulfate, sodium sorbitol, soybean oil, stearic acids, stearyl fumarate, sucrose, surfactants, talc, tragacanth, tetrahydrofurfuryl alcohol, triglycerides, water, and mixtures thereof. 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 substantial 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 trihydrate salt and an excipient selected from the group consisting of agar, alginic acid, aluminum hydroxide, benzyl alcohol, benzyl benzoate, 1,3-butylene glycol, carbomers, castor oil, cellulose, cellulose acetate, cocoa butter, corn starch, corn oil, cottonseed oil, cross-povidone, diglycerides, ethanol, ethyl cellulose, ethyl laureate, ethyl oleate, fatty acid esters, gelatin, germ oil, glucose, glycerol, groundnut oil, hydroxypropylmethyl cellulose, isopropanol, isotonic saline, lactose, magnesium hydroxide, magnesium stearate, malt, mannitol, monoglycerides, olive oil, peanut oil, potassium phosphate salts, potato starch, povidone, propylene glycol, Ringer's solution, safflower oil, sesame oil, sodium carboxymethyl cellulose, sodium phosphate salts, sodium lauryl sulfate, sodium sorbitol, soybean oil, stearic acids, stearyl fumarate, sucrose, surfactants, talc, tragacanth, tetrahydrofurfuryl alcohol, triglycerides, water, and mixtures thereof. 15. The composition of claim 14, wherein the salt is present in a therapeutically acceptable amount. 16. The composition of claim 14, wherein the salt is crystalline. 17. The composition of claim 16, wherein the salt has substantial crystalline purity. 18. The composition of claim 17, wherein the salt has at least about 95% crystalline purity. 19. The composition of claim 16, 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. 20. The composition of claim 16, 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. 21. The composition of claim 14, wherein the salt has substantial chemical purity. 22. The composition of claim 21, wherein the salt is about 97% chemically pure. 23. The composition of claim 21, wherein the salt is about 98% chemically pure. 24. The composition of claim 21, wherein the salt is about 100% chemically pure. 25. The composition of claim 14, wherein the composition is an orally administered dosage form. 26. The composition of claim 14, wherein the composition is a parenterally administered dosage form. 27. 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 selected from the group consisting of agar, alginic acid, aluminum hydroxide, benzyl alcohol, benzyl benzoate, 1,3-butylene glycol, carbomers, castor oil, cellulose, cellulose acetate, cocoa butter, corn starch, corn oil, cottonseed oil, cross-povidone, diglycerides, ethanol, ethyl cellulose, ethyl laureate, ethyl oleate, fatty acid esters, gelatin, germ oil, glucose, glycerol, groundnut oil, hydroxypropylmethyl cellulose, isopropanol, isotonic saline, lactose, magnesium hydroxide, magnesium stearate, malt, mannitol, monoglycerides, olive oil, peanut oil, potassium phosphate salts, potato starch, povidone, propylene glycol, Ringer's solution, safflower oil, sesame oil, sodium carboxymethyl cellulose, sodium phosphate salts, sodium lauryl sulfate, sodium sorbitol, soybean oil, stearic acids, stearyl fumarate, sucrose, surfactants, talc, tragacanth, tetrahydrofurfuryl alcohol, triglycerides, water, and mixtures thereof. 28. The method of claim 27, wherein the composition is administered to a mammal. 29. The method of claim 27, wherein the therapeutically acceptable amount is from about 0.03 to about 200 mg/kg body weight. 30. 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 selected from the group consisting of agar, alginic acid, aluminum hydroxide, benzyl alcohol, benzyl benzoate, 1,3-butylene glycol, carbomers, castor oil, cellulose, cellulose acetate, cocoa butter, corn starch, corn oil, cottonseed oil, cross-povidone, diglycerides, ethanol, ethyl cellulose, ethyl laureate, ethyl oleate, fatty acid esters, gelatin, germ oil, glucose, glycerol, groundnut oil, hydroxypropylmethyl cellulose, isopropanol, isotonic saline, lactose, magnesium hydroxide, magnesium stearate, malt, mannitol, monoglycerides, olive oil, peanut oil, potassium phosphate salts, potato starch, povidone, propylene glycol, Ringer's solution, safflower oil, sesame oil, sodium carboxymethyl cellulose, sodium phosphate salts, sodium lauryl sulfate, sodium sorbitol, soybean oil, stearic acids, stearyl fumarate, sucrose, surfactants, talc, tragacanth, tetrahydrofurfuryl alcohol, triglycerides, water, and mixtures thereof. 31. The method of claim 30, wherein the composition is administered to a mammal. 32. The method of claim 30, wherein the therapeutically acceptable amount is from about 0.03 to about 200 mg/kg body weight.