Controlled release antimicrobial compositions and methods for the treatment of otic disorders
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).
1. A method of treating an otic disease or condition in a pediatric patient, wherein the otic disease or condition is selected from acute otitis media with tympanostomy tubes or otitis media requiring tympanostonmy tube placement, the method comprising intratympanically administering to the pediatric patient a composition comprising poloxamer 407 and a therapeutically effective amount of multiparticulate ciprofloxacin, wherein the multiparticulate ciprofloxacin is non-microencapsulated, and wherein the composition provides a sustained release of ciprofloxacin in the ear for a period of at least 5 days after a single intratympanic administration.
2. The method of claim 1 , wherein the composition comprises from about 10 wt % to about 20 wt % poloxamer 407.
3. The method of claim 1 , wherein the composition comprises from about 14 wt % to about 18 wt % poloxamer 407.
4. The method of claim 1 , wherein the composition comprises from about 15 wt % to about 17 wt % poloxamer 407.
5. The method of claim 1 , wherein the composition comprises about 16 wt % poloxamer 407.
6. The method of claim 1 , wherein the multiparticulate ciprofloxacin is essentially in the form of micronized particles.
7. The method of claim 1 wherein the otic disease or condition is acute otitis media with tympanostomy tubes.
8. The method of claim 1 wherein the otic disease or condition is otitis media requiring tympanostonmy tube.
9. A method of treating an otic disease or condition in a non-pediatric patient, wherein the otic disease or condition is selected from acute otitis media with tympanostomy tubes or middle ear effusion with otitis media undergoing tympanostomy tube placement, the method comprising intratympanically administering to the non-pediatric patient a composition comprising poloxamer 407 and a therapeutically effective amount of multiparticulate ciprofloxacin, wherein the multiparticulate ciprofloxacin is non-microencapsulated, and wherein the composition provides a sustained release of ciprofloxacin in the ear for a period of at least 5 days after a single intratympanic administration.
10. The method of claim 9 , wherein the composition comprises from about 10 wt % to about 20 wt % poloxamer 407.
11. The method of claim 9 , wherein the composition comprises from about 14 wt % to about 18 wt % poloxamer 407.
12. The method of claim 9 , wherein the composition comprises from about 15 wt % to about 17 wt % poloxamer 407.
13. The method of claim 9 , wherein the composition comprises about 16 wt % poloxamer 407.
14. The method of claim 9 , wherein the multiparticulate ciprofloxacin is essentially in the form of micronized particles.
15. A method of treating an otic disease or condition in a patient older than 12 years of age, wherein the otic disease or condition is selected from acute otitis media with tympanostomy tubes or middle ear effusion with otitis media undergoing tympanostomy tube placement, the method comprising intratympanically administering to the patient a composition comprising poloxamer 407 and a therapeutically effective amount of multiparticulate ciprofloxacin, wherein the multiparticulate ciprofloxacin is non-microencapsulated, and wherein the composition provides a sustained release of ciprofloxacin in the ear for a period of at least 5 days after a single intratympanic administration.
16. The method of claim 15 , wherein the composition comprises from about 10 wt % to about 20 wt % poloxamer 407.
17. The method of claim 15 , wherein the composition comprises from about 14 wt % to about 18 wt % poloxamer 407.
18. The method of claim 15 , wherein the composition comprises from about 15 wt % to about 17 wt % poloxamer 407.
19. The method of claim 15 , wherein the composition comprises about 16 wt % poloxamer 407.
20. The method of claim 15 , wherein the multiparticulate ciprofloxacin is essentially in the form of micronized particles.
21. The method of claim 1 , wherein the composition is applied on tympanic membrane of the pediatric patient.
22. The method of claim 9 , wherein the composition is applied on tympanic membrane of the non-pediatric patient.
23. The method of claim 15 , wherein the composition is applied on tympanic membrane of the patient.