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Last Updated: March 28, 2024

Details for Patent: 9,757,484


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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)
Filing Date:Oct 30, 2015
Application Number:14/928,920
Claims:1. A method of making a sterilized ciprofloxacin composition, comprising the steps of: (a) heating an aqueous suspension comprising ciprofloxacin particles essentially in the form of ciprofloxacin hydrate particles at a temperature ranging from about 100.degree. C. to about 120.degree. C.; and (b) combining the 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 present in the aqueous suspension at a concentration of from about 4 wt % to about 30 wt %.

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 10 wt % to about 16 wt %.

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

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

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

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

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

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

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

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

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

14. 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.

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

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

17. A sterilized 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.

18. The sterilized otic formulation of claim 17, wherein the multiparticulate ciprofloxacin has a D90 of from about 5 .mu.m to about 40 .mu.m.

19. The sterilized otic formulation of claim 17, wherein the ciprofloxacin particles are homogenized in the sterilized otic formulation.

20. A ready-to-use otic product, comprising an aseptic vial and the sterilized otic formulation of claim 17.

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