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Claims for Patent: 6,589,955

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Claims for Patent: 6,589,955

Title: Pediatric formulation of gatifloxacin
Abstract:There is provided in accordance with the present invention the quinolone antibacterial gatifloxacin adequately taste-masked so that it can be utilized for pediatric formulations. A crystalline co-precipitate of gatifloxacin and one or both of stearic acid and palmitic acid in a narrow weight ratio has been found to effectively mask the bitter taste of gatifloxacin. The taste of gatifloxacin is effectively masked in the mouth and in aqueous suspension through a full dosage cycle, typically fourteen days. Gatifloxacin in the subject crystalline co-precipitates has been found to be readily available for absorption from the stomach.
Inventor(s): Raghavan; Krishnaswamy S. (Cranbury, NJ), Ranadive; Sunanda A. (East Brunswick, NJ), Bembenek; Kenneth S. (Dayton, NJ), Benkerrour; Loutfy (Paris, FR), Trognon; Veronique (La Turballe, FR), Corrao; Richard G. (Jackson, NJ), Esposito; Luigi (Howell, NJ)
Assignee: Bristol-Myers Squibb Company (Princeton, NJ)
Application Number:10/143,487
Patent Claims: 1. A crystalline co-precipitate of gatifloxacin and a fatty acid selected from the group consisting of stearic acid, palmitic acid and mixtures thereof, wherein the weight ratio of gatifloxacin to said fatty acid is from about 1:1.8 to 1:2.3.

2. A crystalline precipitate in accordance with claim 1, wherein the weight ratio of gatifloxacin to said fatty acid is about 1:2.1.

3. A crystalline co-precipitate in accordance with claim 1, wherein said fatty acid is stearic acid.

4. A crystalline co-precipitate in accordance with claim 2, wherein said fatty acid is stearic acid.

5. A crystalline co-precipitate in accordance with claim 1, wherein said fatty acid is palmitic acid.

6. A crystalline co-precipitate in accordance with claim 2, wherein said fatty acid is palmitic acid.

7. A crystalline co-precipitate in accordance with claim 1, wherein said fatty acid is a mixture of stearic acid and palmitic acid in a weight ratio of from about 1:5 to 5:1.

8. A crystalline co-precipitate in accordance with claim 7, wherein said fatty acid is a mixture of stearic acid and palmitic acid in about equal parts by weight.

9. A pharmaceutical composition intended for suspension in water for oral administration comprising a crystalline co-precipitate in accordance with claim 1 and pharmaceutically acceptable excipients.

10. A pharmaceutical composition in accordance with claim 9, wherein said pharmaceutically acceptable excipients comprise at least one member selected from the group consisting of water-soluble flavoring agents and sweeteners.

11. A pharmaceutical composition in accordance with claim 9, wherein the fatty acid in the crystalline co-precipitate is stearic acid.

12. A pharmaceutical composition in accordance with claim 9, wherein the fatty acid in the crystalline co-precipitate is palmitic acid.

13. A pharmaceutical composition in accordance with claim 9, wherein the fatty acid in the crystalline co-precipitate is a mixture of stearic acid and palmitic acid in a weight ratio of from about 1:5 to 5:1.

14. A method for treating infections in a mammal in need thereof comprising orally administering to the mammal an effective amount of an aqueous suspension of the pharmaceutical composition of claim 9.

15. A method for treating infections in a mammal in need thereof comprising orally administering to the mammal an effective amount of an aqueous suspension of the pharmaceutical composition of claim 10.

16. A method for treating infections in a mammal in need thereof comprising orally administering to the mammal an effective amount of an aqueous suspension of the pharmaceutical composition of claim 11.

17. A method in accordance with claim 14, wherein said aqueous suspension contains a sufficient amount of said crystalline precipitate to provide a dosage of 200 mg. of gatifloxacin in each 5 mL thereof.

18. A process of forming a crystalline co-precipitate of gatifloxacin and a fatty acid selected from the group consisting of stearic acid, palmitic acid and mixtures thereof comprising: a) dissolving gatifloxacin and said fatty acid in a weight ratio of from about 1:1.8 to 1:2.3 in a suitable solvent with heating to reflux temperature to effect solution thereof; b) refluxing said solution for from two to three hours with stirring; c) slowly cooling said solution with stirring to about 18.degree. C. over a period of from about 2.5 to 4 hours to precipitate the crystalline co-precipitate of gatifloxacin and said fatty acid; d) maintaining the resultant slurry of said crystalline co-precipitate to about 15.degree. C. to 20.degree. C. for an additional two to four hours; and e) recovering and drying said crystalline co-precipitate.

19. A process in accordance with claim 18, wherein said solution is formed in step a) with gatifloxacin sesquihydrate.

20. A process in accordance with claim 18, wherein said fatty acid is stearic acid.

21. A crystalline co-precipitate formed by the process of claim 18.

22. A crystalline co-precipitate formed by the process of claim 19.

23. A crystalline co-precipitate formed by the process of claim 20.
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