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° 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° C. to 20° 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.
REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional Application Serial No. 60/299,625 filed Jun. 20, 2001.
Provisional Applications (1)
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Number |
Date |
Country |
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60299625 |
Jun 2001 |
US |