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Claims for Patent: 9,084,802

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Claims for Patent: 9,084,802

Title:Tetracycline compositions
Abstract: The present invention relates to compositions, pharmaceutical compositions, and methods for preparing the same, comprising a tetracycline with improved stability and solubility. Some embodiments include a tetracycline with an excess of a divalent or trivalent cation.
Inventor(s): Griffith; David C. (San Marcos, CA), Boyer; Serge (San Diego, CA), Hecker; Scott (Del Mar, CA), Dudley; Michael N. (San Diego, CA)
Assignee: REMPEX PHARMACEUTICALS, INC. (San Diego, CA)
Application Number:14/204,881
Patent Claims: 1. A method of treating a bacterial infection in a subject, wherein the method consists of: administering a therapeutically effective amount of a composition to a subject in need thereof via an intravenous route of administration, wherein the composition consists of an aqueous solution consisting of minocycline or a salt thereof, a salt that comprises a magnesium cation, and a base, wherein the molar ratio of magnesium cation to minocycline is greater than about 4:1, and wherein the composition has a pH that is no less than 4 and no greater than 6, whereby injection site hemolysis of red blood cells is reduced relative to intravenous administration of a composition that does not include magnesium.

2. The method of claim 1, wherein the concentration of minocycline in the composition is at least 0.1 mg/ml.

3. The method of claim 1, wherein the concentration of minocycline in the composition is at least 1 mg/ml.

4. The method of claim 1, wherein the concentration of minocycline in the composition is at least 5 mg/ml.

5. The method of claim 1, wherein the concentration of minocycline in the composition is at least 10 mg/ml.

6. The method of claim 1, wherein the composition has a pH between about 4.5 to about 6.

7. The method of claim 1, wherein the composition has a pH between about 4.5 to about 5.5.

8. The method of claim 1, wherein the molar ratio of magnesium cation to minocycline is greater than or equal to 5:1.

9. The method of claim 1, wherein the molar ratio of magnesium cation to minocycline is from 5:1 to 10:1.

10. The method of claim 1, wherein the osmolality of the solution is less than 500 mOsm/kg.

11. The method of claim 1, wherein the osmolality of the solution is less than 400 mOsm/kg.

12. The method of claim 1, wherein the osmolality of the solution is less than 350 mOsm/kg.

13. The method of claim 1, wherein the salt that comprises a magnesium cation is magnesium sulfate.

14. The method of claim 1, wherein the salt that comprises a magnesium cation is magnesium acetate.

15. The method of claim 1, wherein the salt that comprises a magnesium cation is magnesium chloride.

16. The method of claim 1, wherein the base is NaOH.

17. The method of claim 1, wherein the total volume of the composition administered is less than 1000 ml.

18. The method of claim 1, wherein the total volume of the composition administered is less than 500 ml.

19. The method of claim 1, wherein the total volume of the composition administered is less than 200 ml.

20. The method of claim 1, wherein the total volume of the composition administered is less than 110 ml.

21. The method of claim 1, wherein the composition is administered in less than 60 minutes.

22. The method of claim 1, wherein the composition is administered in less than 40 minutes.

23. The method of claim 1, wherein the composition is administered in less than 20 minutes.

24. The method of claim 1, wherein the amount of minocycline in the composition is at least 80 mg.

25. The method of claim 1, wherein the amount of minocycline in the composition is at least 100 mg.

26. The method of claim 1, wherein the amount of minocycline in the composition is about 100 mg.

27. The method of claim 1, wherein the amount of minocycline in the composition is at least 130 mg.

28. The method of claim 1, wherein the amount of minocycline in the composition is at least 200 mg.

29. The method of claim 1, wherein the amount of minocycline in the composition is at least 300 mg.

30. The method of claim 1, wherein the amount of minocycline in the composition is at least 400 mg.

31. The method of claim 1, wherein the amount of minocycline in the composition is at least 500 mg.
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