OTIC GEL FORMULATIONS FOR TREATING OTITIS EXTERNA
Disclosed herein are methods for the treatment of otic diseases or conditions with antimicrobial agent compositions and formulations administered locally to an individual afflicted with an otic disease or condition, through direct application of these compositions and formulations onto or via perfusion into the targeted auris structure(s).
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19 . A kit comprising: a syringe and an aqueous thermoreversible gel composition, wherein the composition comprises about 6.0% by weight of micronized ciprofloxacin and 15-17% by weight of poloxamer 407, and wherein the kit further comprises an instruction to prepare and inject 0.2 mL of the thermoreversible gel composition to provide a single dose of about 12 mg of micronized ciprofloxacin.
20 . The kit of claim 19 , wherein the instruction is provided on a package insert.
21 . The kit of claim 19 , wherein the composition is free of butylated hydroxytoluene (BHT).
22 . The kit of claim 19 , wherein the composition is preservative-free.
23 . The kit of claim 19 , wherein the composition further comprises a buffering agent.
24 . The kit of claim 23 , wherein the buffering agent comprises tromethamine.
25 . The kit of claim 19 , wherein the composition further comprises a pH adjusting agent.
26 . The kit of claim 25 , wherein the pH adjusting agent comprises hydrochloric acid.
27 . The kit of claim 19 , wherein the composition has a pH of about 7.0 to about 8.0.
28 . The method of claim 19 , wherein the composition further comprises an osmolarity modifier.
29 . The method of claim 19 , wherein the osmolarity modifier comprises sodium chloride.
30 . The method of claim 19 , wherein the composition has an osmolarity of from about 250 mOsm/kg to about 300 mOsm/kg.
31 . The method of claim 19 , wherein the composition has a gelation temperature of from about 20° C. to about 30° C.