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Claims for Patent: 6,194,429

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Claims 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.
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