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.

What is claimed is: 
     
         1 . A kit for treating otic infections, the kit comprising an aqueous suspension composition comprising 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, said composition in a sealed container together with instructions for use thereof, and wherein said instructions indicate that four drops of the aqueous suspension composition are administered to a patient's ear twice a day and/or wherein said instructions indicate that three drops of the aqueous suspension composition are administered to a patient's ear twice a day. 
     
     
         2 . The kit of  claim 1  wherein the dexamethasone is dexamethasone alcohol and the ciprofloxacin is ciprofloxacin hydrochloride, monohydrate. 
     
     
         3 . The kit of  claim 1  wherein the aqueous suspension composition contains 0.1% (wt.) dexamethasone and 0.3% (wt.) ciprofloxacin. 
     
     
         4 . The kit of  claim 1  wherein the dexamethasone has an average particle size on a mean volume basis of less than 3 μm. 
     
     
         5 . The kit of  claim 1  wherein said tonicity agent is NaCl. 
     
     
         6 . The kit 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 kit of  claim 1  wherein said nonionic surfactant is tyloxapol. 
     
     
         8 . The kit of  claim 7  wherein said tyloxapol is present at a concentration of 0.05% (wt.). 
     
     
         9 . The kit of  claim 1  wherein said aqueous suspension further comprises a suspending agent. 
     
     
         10 . The kit of  claim 9  wherein said suspending agent is hydroxyethylcellulose. 
     
     
         11 . The kit of  claim 10  wherein said hydroxyethylcellulose is present at a concentration of 0.2% (wt.). 
     
     
         12 . The kit 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 kit 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 kit of  claim 1  wherein the otitis media is acute otitis media. 
     
     
         15 . The kit of  claim 1  wherein the otitis media is chronic suppurative otitis media. 
     
     
         16 . The kit of  claim 1  wherein the patient is a pediatric patient. 
     
     
         17 . The kit 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 kit of  claim 1  wherein the aqueous suspension has a pH of 3-6. 
     
     
         19 . The kit of  claim 1  wherein said treating comprises treating otorrhea associated with a middle ear infection. 
     
     
         20 . The kit of  claim 1  wherein said treating comprises treating acute otitis externa associated with a middle ear infection. 
     
     
         21 . The kit of  claim 1  wherein said treating comprises treating granulation tissue associated with a middle ear infection. 
     
     
         22 . The kit of  claim 1  wherein four drops of said aqueous suspension composition are administered to the patient's ear twice a day.