Claims for Patent: 6,194,429

Summary for Patent: 6,194,429

Title:	Alatrofloxacin parenteral compositions
Abstract:	The present invention relates to alatrofloxacin mesylate substantially free of less polar impurities, to parenteral compositions of alatrofloxacin mesylate and to processes for purifying alatrofloxacin mesylate.
Inventor(s):	Guinn; Robert Mark (Mystic, CT), Lambert; John Francis (North Stonington, CT), Guhan; Subramanian Sam (Niantic, CT), Walinsky; Stanley Walter (Mystic, CT)
Assignee:	Pfizer Inc (New York, NY)
Application Number:	09/403,886
Patent Claims:	1. A process of purifiing a compound of the formula ##STR8## comprising, treating an impure reaction product containing an amount of said compound of formula I and less polar impurities, with a hydrophobic resin. 2. A process according to claim 1, wherein said less polar impurities have a retention time of about 2.1 to about 30 minutes. 3. A process according to claim 1, wherein one of said less polar impurities has a retention time of about 9 to about 12 minutes. 4. A process according to claim 1, wherein one of said less polar impurities has the formula ##STR9## 5. A process according to claim 1, wherein said impurities, after treatment, comprise less than about 60 ppm relative to the total weight of the purified product. 6. A process according to claim 1, wherein said impurities, after treatment, comprise less than about 20 ppm relative to the total weight of the purified product. 7. A process according to claim 1, wherein said hydrophobic resin is a crosslinked polystyrene resin. 8. A compound of the formula ##STR10## substantially free of less polar impurities. 9. A compound according to claim 8, wherein said compound of formula I is substantially free of a compound of formula II ##STR11## 10. A parenteral composition, comprising an antibacterially effective amount of a compound of the formula I, ##STR12## or a pharmaceutically acceptable salt thereof, substantially free of less polar impurities, and a pharmaceutically acceptable carrier. 11. A parenteral composition, comprising an antibacterially effective amount of a compound of the formula I, ##STR13## or a pharmaceutically acceptable salt thereof, substantially free of a compound of formula II ##STR14## and a pharmaceutically acceptable carrier. 12. A parenteral composition according to claim 8, comprising a compound of formula I and water. 13. A parenteral composition according to claim 8, wherein the compound of formula I is a lyophylate. 14. A parenteral composition according to claim 9, wherein the compound of formula I comprises about 10 mg to about 700 mg of compound in a unit dosage container. 15. A parenteral composition according to claim 9, wherein the compound of formula I comprises about 275 mg to about 500 mg of compound in a unit dosage container. 16. A parenteral composition according to claim 8, wherein the compound of formula I comprises about 10 mg to about 700 mg of compound in a unit dosage container. 17. A parenteral composition according to claim 8, wherein the compound of formula I comprises about 275 mg to about 500 mg of compound in a unit dosage container. 18. A compound of the formula ##STR15## 19. A pharmaceutical composition, comprising an antibacterially effective amount of a compound according to claim 18, or a pharmaceutically acceptable salt thereof. 20. A method of treating a bacterial infection, comprising administering to a subject affected by a bacterial infection an antibacterially effective amount of a compound according to claim 18. 21. A compound of formula IlIl ##STR16## 22. A pharmaceutical composition, comprising an antibacterially effective amount of a compound according to claim 21, or a pharmaceutically acceptable salt thereof. 23. A method of treating a bacterial infection, comprising administering to a subject affected by a bacterial infection an antibacterially effective amount of a compound according to claim 21. 24. The composition of claim 8 wherein said impurities comprise less than about 60 ppm relative to the total weight of the composition. 25. The composition of claim 8 wherein said impurities comprise less than about 20 ppm relative to the total weight of the composition.