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Claims for Patent: 9,220,796

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Claims for Patent: 9,220,796

Title:Sterilization of ciprofloxacin composition
Abstract: Disclosed herein are methods of making sterilized ciprofloxacin compositions. In some embodiments, the method includes the steps of: (a) forming an aqueous suspension comprising ciprofloxacin particles; (b) heating the aqueous suspension comprising ciprofloxacin particles at a temperature range of from about 100.degree. C. to about 120.degree. C.; and (c) allowing the aqueous suspension comprising ciprofloxacin particles to cool down. Also described herein are otic formulations containing ciprofloxacin formed by the disclosed methods, and therapeutic use of such otic formulation for providing sustained release of ciprofloxacin into the ear for treating various otic disorders and conditions.
Inventor(s): Coleman; Scott H. (San Diego, CA), Liaw; Wei-Cheng (San Diego, CA), Wroblewski; Jerry (San Mateo, CA), Savel; Robert (San Diego, CA)
Assignee: OTONOMY, INC. (San Diego, CA)
Application Number:14/789,771
Patent Claims: 1. A method of making a sterilized ciprofloxacin composition, comprising the steps of: (a) forming an aqueous suspension comprising ciprofloxacin particles; (b) heating the aqueous suspension comprising ciprofloxacin particles at a temperature range of from about 100.degree. C. to about 120.degree. C.; (c) allowing the aqueous suspension comprising ciprofloxacin particles to cool down; and (d) combining the cooled aqueous suspension comprising ciprofloxacin particles with a sterilized aqueous solution comprising a thermoreversible polymer to form an otic formulation.

2. The method of claim 1, wherein the aqueous suspension in step (a) is essentially free of organic solvent.

3. The method of claim 1, wherein the ciprofloxacin particles in step (a) are essentially in the form of ciprofloxacin hydrate particles.

4. The method of claim 1, wherein the ciprofloxacin particles in step (a) are present in the aqueous suspension at a concentration of from about 4 wt % to about 30 wt %.

5. The method of claim 1, wherein the ciprofloxacin particles in step (a) are present in the aqueous suspension at a concentration of from about 10 wt % to about 16 wt %.

6. The method of claim 1, wherein the ciprofloxacin particles in step (a) have a D90 of from about 40 .mu.m to about 80 .mu.m.

7. The method of claim 1, wherein the ciprofloxacin particles in step (a) have a D90 of from about 50 .mu.m to about 70 .mu.m.

8. The method of claim 1, wherein the aqueous suspension in step (b) is heated at a temperature of from about 105.degree. C. to about 115.degree. C.

9. The method of claim 1, wherein the aqueous suspension in step (b) is heated for a period of from about 30 minutes to about 5 hours.

10. The method of claim 1, wherein the aqueous suspension in step (b) is heated at a temperature of about 115.degree. C. for a period of about 1 hour.

11. The method of claim 1, wherein the aqueous suspension in step (b) is heated at a temperature of about 110.degree. C. for a period of from about 1 hour to about 2 hours.

12. The method of claim 1, wherein the aqueous suspension in step (b) is heated at a constant temperature within the temperature range.

13. The method of claim 1, wherein the aqueous suspension in step (b) is heated at variable temperatures within the temperature range.

14. The method of claim 1, wherein the ciprofloxacin particles in step (b) are homogenized in the aqueous suspension when heated.

15. The method of claim 1, wherein the ciprofloxacin particles in step (c) are homogenized in the aqueous suspension during cooling.

16. The method of claim 1, wherein the aqueous suspension in step (c) is allowed to cool down to from about 2.degree. C. to about 10.degree. C.

17. The method of claim 1, wherein the ciprofloxacin particles in step (c) have a D90 of from about 5 .mu.m to about 40 .mu.m after cooling down.

18. The method of claim 1, wherein the thermoreversible polymer in step (d) is poloxamer 407.

19. The method of claim 1, wherein the aqueous solution in step (d) further comprises a buffer agent.

20. The method of claim 1, wherein the aqueous solution in step (d) further comprises an osmolarity modifier.

21. The method of claim 1, wherein the aqueous solution in step (d) is sterilized through filtration sterilization, heat sterilization, or radiation sterilization.

22. The method of claim 1, wherein the aqueous solution in step (d) is sterilized through filtration sterilization.

23. The method of claim 1, wherein the aqueous suspension and the aqueous solution are combined under aseptic condition.

24. The method of claim 1, wherein the otic formulation comprises from about 5.5 wt % to about 6.5 wt % of ciprofloxacin.

25. The method of claim 1, wherein the otic formulation comprises from about 15 wt % to about 17 wt % of the thermoreversible polymer, and wherein the thermoreversible polymer is poloxamer 407.

26. The method of claim 1, where the otic formulation has a pH of from about 7.0 to about 8.0.

27. The method of claim 1, where the otic formulation has an osmolarity of from about 270 mOsm/L to about 320 mOsm/L.

28. A sterlized otic formulation formed by the method of claim 1, the sterilized otic formulation comprising: from about 5.5 wt % to about 6.5 wt % multiparticulate ciprofloxacin; from about 15 wt % to about 17 wt % poloxamer 407; and water, wherein the composition has a pH of from about 7.0 to about 8.0, an osmolarity of from about 270 to about 320 mOsm/L, and wherein the sterilized otic formulation provides sustained release of a therapeutically effective amount of ciprofloxacin into the ear for a period of at least 5 days after a single administration.

29. The sterilized otic formulation of claim 28, wherein the multiparticulate ciprofloxacin has a D90 of from about 5 .mu.m to about 40 .mu.m.

30. A ready-to-use otic product, comprising an aseptic vial and the sterilized otic formulation of claim 28.
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