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Claims for Patent: 9,402,805

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Claims for Patent: 9,402,805

Title:Method of treating middle ear infections
Abstract: Aqueous suspension formulations containing dexamethasone and ciprofloxacin are disclosed for the treatment of middle ear infections in human patients having an open tympanic membrane.
Inventor(s): Wall; G. Michael (Fort Worth, TX), Conroy; Peter J. (Fort Worth, TX)
Assignee: Alcon Pharmaceuticals Ltd. (Fribourg, CH)
Application Number:15/142,225
Patent Claims: 1. A method of treating a human patient comprising the steps of: (a) diagnosing the patient as having otitis media and an open tympanic membrane and/or having acute otitis externa in at least one ear; and (b) topically applying into the ear canal of the patients ear an aqueous suspension composition containing a combination of ciprofloxacin and dexamethasone, wherein the composition comprises a) 0.01-0.5% (wt.) dexamethasone; b) 0.1-0.4% (wt.) ciprofloxacin; c) 0.1-0.9% (wt.) tonicity agent; d) 0.01-0.2% (wt.) of a nonionic surfactant; and e) a buffer; wherein three or four drops of the aqueous suspension composition are administered to the patients ear twice a day, and wherein each drop is 30-35 .mu.L.

2. The method of claim 1 wherein the dexamethasone is dexamethasone alcohol and the ciprofloxacin is ciprofloxacin hydrochloride, monohydrate.

3. The method of claim 1 wherein the aqueous suspension composition contains 0.1% (wt.) dexamethasone and 0.3% (wt.) ciprofloxacin.

4. The method of claim 1 wherein the dexamethasone has an average particle size on a mean volume basis of less than 3 .mu.m.

5. The method of claim 1 wherein said tonicity agent is NaCl.

6. The method of claim 5 wherein said NaCl is present in an amount sufficient to cause the composition to have an osmolality of 250-350 mOsm.

7. The method of claim 1 wherein said nonionic surfactant is tyloxapol.

8. The method of claim 7 wherein said tyloxapol is present at a concentration of 0.05% (wt.).

9. The method of claim 1 wherein said aqueous suspension further comprises a suspending agent.

10. The method of claim 9 wherein said suspending agent is hydroxyethylcellulose.

11. The method of claim 10 wherein said hydroxyethylcellulose is present at a concentration of 0.2% (wt.).

12. The method of claim 1 wherein the aqueous suspension composition consists essentially of a) 0.1% (wt.) dexamethasone alcohol; b) 0.35% (wt.) ciprofloxacin hydrochloride, monohydrate; c) NaCl in an amount sufficient to cause the composition to have an osmolality of 250-350 mOsm; d) 0.2% (wt.) hydroxyethyl cellulose; e) 0.05% (wt.) tyloxapol; f) a buffer comprising sodium acetate and acetic acid; g) 0.01% (wt.) benzalkonium chloride; h) 0.01% (wt.) edetate disodium; i) 0.6% (wt.) boric acid; and wherein the composition has a pH of about 4.5.

13. The method of claim 1 wherein the method further comprises the step of pumping the tragus to force the aqueous suspension composition through the open tympanic membrane and into the middle ear.

14. The method of claim 1 wherein the otitis media is acute otitis media.

15. The method of claim 1 wherein the otitis media is chronic suppurative otitis media.

16. The method of claim 1 wherein the patient is a pediatric patient.

17. The method of claim 1 wherein the aqueous suspension composition containing a combination of ciprofloxacin and dexamethasone is packaged with directions for use that indicate the composition may be used to treat otitis media in patients with an open tympanic membrane.

18. The method of claim 1 wherein the aqueous suspension has a pH of 3-6.

19. The method of claim 1 wherein said treating comprises treating otorrhea associated with a middle ear infection.

20. The method of claim 1 wherein said treating comprises treating acute otitis externa associated with a middle ear infection.

21. The method of claim 1 wherein said treating comprises treating granulation tissue associated with a middle ear infection.

22. The method of claim 1 wherein four drops of said aqueous suspension composition are administered to the patients ear twice a day.
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