Auris formulations for treating otic diseases and conditions
Disclosed herein are compositions and methods for the treatment of otic disorders with immunomodulating agents and auris pressure modulators. In these methods, the auris compositions and formulations are administered locally to an individual afflicted with an otic disorder, through direct application of the immunomodulating and/or auris pressure modulating compositions and formulations onto the auris media and/or auris interna target areas, or via perfusion into the auris media and/or auris interna structures.
1. A method of providing sustained release of an auris sensory cell modulator into an ear of a patient, the method comprising intratympanically administering an otic composition to said patient, wherein the otic composition comprises a multiparticulate and non-microencapsulated auris sensory cell modulator and an auris acceptable gel, wherein the auris sensory cell modulator is an otic hair cell growth factor modulator, wherein the otic hair cell growth factor modulator is not a growth factor, and wherein the otic hair cell growth factor modulator modulates a receptor of at least one otic hair cell growth factor.
2. The method of claim 1 , wherein the auris acceptable gel has a gelation viscosity between about 100 cP and about 1,000,000 cP.
3. The method of claim 1 , wherein the auris acceptable gel is capable of being injected by a 18-30 gauge needle or cannula through the tympanic membrane to an area on or near the round window membrane.
4. The method of claim 1 , wherein the otic composition has an osmolarity of about 100 mOsm/L to about 500 mOsm/L.
5. The method of claim 1 , wherein the multiparticulate auris sensory cell modulator is a micronized auris sensory cell modulator.
6. The method of claim 1 , wherein the otic composition has a pH between 7.0 and 8.0.
7. The method of claim 1 , wherein the at least one otic hair cell growth factor is selected from brain-derived neurotrophic factor (BDNF), ciliary neurotrophic factor (CNTF), glial cell-line derived neurotrophic factor (GDNF), neurotrophin-3, neurotrophin-4, fibroblast growth factor (FGF), insulin-like growth factor (IGF), epidermal growth factor (EGF), platelet-derived growth factor (PDGF), or any combination thereof.
8. The method of claim 1 , wherein sustained release of the auris sensory cell modulator into the cochlea occurs for a period of at least 5 days after a single administration.