Extended-release drug delivery compositions

Abstract

An extended-release drug delivery composition and method of administering the same is provided. The composition comprises microspheres loaded with a biologically-active agent and suspended in a soluble polymer capable of forming a film upon injection onto a biological surface.

What is claimed is: 
     
         1 . A composition comprising:
 a soluble polymer, wherein the soluble polymer is from 0.5% to about 10% w/v of the composition;   a carrier liquid, wherein the carrier liquid is able to evaporate at 37° C.; and   a biologically-active agent.   
     
     
         2 . The composition of  claim 1  further comprising a microsphere, wherein the microsphere comprises the biologically-active agent. 
     
     
         3 . The composition of  claim 1  further comprising a plurality of microspheres, wherein the plurality of microspheres comprises the biologically-active agent, and wherein at least 90% of the plurality of microspheres have a particle diameter that does not deviate more than 10% from a mean particle diameter of the plurality of microspheres. 
     
     
         4 . The composition of  claim 4  wherein the mean particle diameter is less than 150 μm. 
     
     
         5 . The composition of  claim 4  wherein the mean particle diameter is from about 30 μm to about 60 μm. 
     
     
         6 . The composition of  claim 1  wherein the soluble polymer is selected from the group consisting of polyvinyl alcohol (PVA), polyvinyl acetate (PVAc), alginate, polyethylene glycol (PEG), hydroxypropyl methyl cellulose (HPMC), polyvinyl pyrrolidone (PVP), eudragits, collagen, and gelatin. 
     
     
         7 . The composition of  claim 1  further comprising a surfactant, wherein the surfactant is selected from the group consisting of polysorbate 20, polysorbate 60, polysorbate 80 or sorbitan laurate. 
     
     
         8 . A composition comprising:
 a means for forming a film on a biological tissue of a human subject; and   a biologically-active agent.   
     
     
         9 . The composition of  claim 11  further comprising a microsphere, wherein the microsphere comprises the biologically-active agent. 
     
     
         10 . The composition of  claim 11  further comprising a plurality of microspheres, wherein the plurality of microspheres comprises the biologically-active agent, and wherein at least 90% of the plurality of microspheres have a particle diameter that does not deviate more than 10% from a mean particle diameter of the plurality of microspheres. 
     
     
         11 . The composition of  claim 11  wherein the mean particle diameter is less than 150 μm. 
     
     
         12 . The composition of  claim 11  wherein the biological tissue is a biological barrier structure. 
     
     
         13 . The composition of  claim 12  wherein the biological barrier structure is the round window membrane. 
     
     
         14 . A method for providing an extended-release treatment to a subject, the method comprising the step of injecting a composition onto a biological tissue of a subject, wherein the composition comprises:
 a means for forming a film on the biological tissue; and   a biologically-active agent.   
     
     
         15 . The method of  claim 14  wherein the composition further comprises a plurality of microspheres, wherein the plurality of microspheres comprises the biologically-active agent, and wherein at least 90% of the plurality of microspheres have a particle diameter that does not deviate more than 10% from a mean particle diameter of the plurality of microspheres. 
     
     
         16 . The method of  claims 15  wherein the mean particle diameter is less than 150 μm. 
     
     
         17 . The method of  claim 14  wherein the biological tissue is a biological barrier structure. 
     
     
         18 . The method  claim 17  wherein the biological barrier structure is the round window membrane of the inner ear. 
     
     
         19 . The method of  claim 18  wherein the step of injecting the composition is performed by an intratympanic injection. 
     
     
         20 . The method of  claim 14  wherein the biological tissue is the round window membrane and the subject is suffering from sensorineural hearing loss, and wherein the biologically-active agent is a therapeutic compound used in the treatment of sensorineural hearing loss.