Controlled release auris sensory cell modulator 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 auris sensory cell modulating 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 - 22 . (canceled) 
     
     
         23 . A method of treating a middle or inner ear disorder comprising intratympanically administering to an individual in need thereof a controlled release composition comprising a pharmaceutical agent and a thermosetting polymer; wherein the pharmaceutical agent is selected from uncoated NMDA receptor antagonists and is suspended in the composition, and the thermosetting polymer has a gelation temperature of between about 12° C. to about 20° C. 
     
     
         24 . The method of  claim 23 , wherein the thermosetting polymer is polaxamer. 
     
     
         25 . The method of  claim 24 , wherein the poloxamer is poloxamer 407. 
     
     
         26 . The method of  claim 25 , wherein the poloxamer has a concentration of about 20% w/w. 
     
     
         27 . The method of  claim 23 , wherein the controlled release composition provides controlled release of the pharmaceutical agent for an extended period of time of one or more days. 
     
     
         28 . The method of  claim 23 , wherein the pharmaceutical agent is gacyclidine. 
     
     
         29 . The method of  claim 23 , wherein the controlled release composition further comprises a phosphate which buffers the pH of the controlled release composition to a pH range of about 7.0-7.6. 
     
     
         30 . The method of  claim 23 , wherein the controlled release composition is contained in a syringe. 
     
     
         31 . The method of  claim 30 , wherein a single dose of the controlled release composition in the syringe is at least 50 μL. 
     
     
         32 . The method of  claim 23 , wherein the controlled release composition is administered by injecting it into the middle ear. 
     
     
         33 . The method of  claim 23 , wherein the controlled release composition is administered by injection or surgical manipulation. 
     
     
         34 . The method of  claim 23 , wherein the middle or inner ear disorder is selected from the group consisting of tinnitus, hearing loss, vertigo, Meniere's disease, infections, and inflammation. 
     
     
         35 . The method of  claim 23 , wherein the inner ear disorder is tinnitus. 
     
     
         36 . A method of treating a middle or inner ear disorder comprising intratympanically administering to an individual in need thereof a controlled release composition comprising a pharmaceutical agent and a thermosetting polymer; wherein the pharmaceutical agent is selected from uncoated NMDA receptor antagonists and is suspended in the composition, and the thermosetting polymer has a gelation temperature of between about 12° C. to about 20° C.,
 wherein the thermosetting polymer is poloxamer 407 and has a concentration of about 20% (w/w), and 
 wherein the pharmaceutical agent is gacyclidine. 
 
     
     
         37 . The method of  claim 36 , wherein the controlled release composition provides controlled release of the pharmaceutical agent for an extended period of time of one or more days. 
     
     
         38 . The method of  claim 36 , wherein the controlled release composition further comprises a phosphate which buffers the pH of the controlled release composition to a pH range of about 7.0-7.6. 
     
     
         39 . The method of  claim 36 , wherein the controlled release composition is contained in a syringe. 
     
     
         40 . The method of  claim 39 , wherein a single dose of the controlled release composition in the syringe is at least 50 μL. 
     
     
         41 . The method of  claim 36 , wherein the controlled release composition is administered by injecting it into the middle ear. 
     
     
         42 . The method of  claim 36 , wherein the controlled release composition is administered by injection or surgical manipulation. 
     
     
         43 . The method of  claim 36 , wherein the middle or inner ear disorder is selected from the group consisting of tinnitus, hearing loss, vertigo, Meniere's disease, infections, and inflammation. 
     
     
         44 . The method of  claim 36 , wherein the inner ear disorder is tinnitus.