Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing
|Title:||Controlled release corticosteroid compositions and methods for the treatment of otic disorders|
|Abstract:||Disclosed herein are compositions and methods for the treatment of otic disorders with steroid, NSAID, and/or adenosine triphosphatase ("ATPase") modulator agents. In these methods, the steroidal, NSAID, and/or ATPase compositions and formulations are administered locally to an individual afflicted with an otic disorder, 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), Piu; Fabrice (San Diego, CA), Ye; Qiang (San Diego, CA), Dellamary; Luis A. (San Marcos, CA), Lebel; Carl (Malibu, 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)|
|Filing Date:||Jul 25, 2011|
|Claims:||1. A pharmaceutical composition comprising (i) a copolymer of polyoxyethylene and polyoxypropylene in an amount sufficient to provide a gelation temperature of between about 19.degree. C. and about 42.degree. C., a gelation viscosity between about 15,000 cP and about 1,000,000 cP; and a non-gelation viscosity that allows injection with a 18-31 gauge needle through the tympanic membrane on or near the round window membrane; (ii) between about 1-70 mg/mL of a multiparticulate anti-inflammatory corticosteroid; and (iii) having an osmolarity from 100 to 1000 mOsm/L; wherein the composition provides a sustained release of the corticosteroid in to the inner ear for a period of at least 5 days after a single administration. |
2. The composition of claim 1, wherein the anti-inflammatory corticosteroid is dexamethasone, dexamethasone ester, or pharmaceutically acceptable salt thereof.
3. The composition of claim 1, wherein the anti-inflammatory corticosteroid is methylprednisolone, or pharmaceutically acceptable salt thereof.
4. The composition of claim 1, wherein the anti-inflammatory corticosteroid is prednisolone, or pharmaceutically acceptable salt thereof.
5. The composition of claim 1, wherein the composition has a pH between about 6.6 and about 8.0.
6. The composition of claim 1, further comprising a delivery system for the delivery of the composition to or near to the round window.
7. The composition of claim 6, wherein the delivery system comprises a needle for delivery of the composition.
8. The composition of claim 7, wherein the needle is part of a syringe and needle apparatus, a hypodermic needle, a micro-otoscope.
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.