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|Title:||Controlled release antimicrobial compositions and methods for the treatment of otic disorders|
|Abstract:||Disclosed herein are compositions and 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).|
|Inventor(s):||Lichter; Jay (Rancho Santa Fe, CA), Lebel; Carl (Malibu, CA), Piu; Fabrice (San Diego, CA), Ye; Qiang (San Diego, CA), Dellamary; Luis A. (San Marcos, CA), Trammel; Andrew M. (Olathe, KS), Harris; Jeffrey P. (La Jolla, CA)|
|Assignee:||Otonomy, Inc. (San Diego, CA) The Regents of the University of California (Oakland, CA)|
1. A method of treating an otic infection or inflammation comprising intratympanically administering to an individual in need thereof a composition comprising a therapeutically
effective amount of a multiparticulate antimicrobial agent, the composition further comprising (i) a-copolymer of polyoxyethylene and polyoxypropylene in an amount sufficient to provide a non-gelation viscosity that allows injection with a 18-31 gauge
needle through the tympanic membrane into the ear, a gelation viscosity between about 15,000 cP and about 1,000,000 cP and a gelation temperature of between about room temperature and about body temperature; and (ii) having an osmolarity of less than
1000 mOsm/L; wherein the composition is a liquid at about room temperature and is administered at or about room temperature, and provides a sustained release of the antimicrobial agent in the ear for a period of at least 5 days after a single
2. The method of claim 1, wherein the composition provides sustained release of the antimicrobial agent in the ear for a period of at least 10 days.
3. The method of claim 1, wherein the antimicrobial agent is an antibiotic.
4. The method of claim 3, wherein the antibiotic is a quinolone antibiotic.
5. The method of claim 4, wherein the quinolone antibiotic is selected from ciprofloxacin, enoxacin, gatifloxacin, levofloxacin, lomefloxacin, moxifloxacin, nonfloxacin, ofloxacin, trovafloxacin, grepafloxacin, and sparfloxacin.
6. The method of claim 4, wherein the quinolone antibiotic is ciprofloxacin.
7. The method of claim 1, wherein the copolymer of polyoxyethylene and polyoxypropylene is poloxamer 407.
8. The method of claim 1, wherein the otic infection or inflammation is otitis media.
9. The method of claim 8, wherein the otitis media is otitis media with effusion.
10. The method of claim 1, wherein the otic infection or inflammation is associated with an otic intervention.
11. The method of claim 10, wherein the infection or inflammation associated with an otic intervention is otitis media with effusion associated with surgery for the insertion of a tympanostomy tube.
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