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 method for treating a subject suffering from a disorder of the inner ear, comprising:
 injecting a composition to a biological tissue of the ear of the subject no more than one time in a 14 day period,   wherein the composition comprises a biologically-active agent dispersed in a film-forming agent,   wherein the film-forming agent comprises a soluble polymer and a carrier liquid,   wherein the film-forming agent is free of solvent,   wherein the carrier liquid is capable of evaporating at a temperature of about 37° C.,   and wherein the film-forming agent is capable of forming a film on the biological tissue upon evaporation of at least a portion of the carrier liquid.   
     
     
         2 . The method of  claim 1 , further comprising, after injecting the composition to the biological tissue:
 allowing the at least a portion of the carrier liquid to evaporate, whereby the film-forming agent forms a film on the biological tissue.   
     
     
         3 . The method 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), an eudragit, collagen, gelatin and combinations thereof. 
     
     
         4 . The method of  claim 1 , wherein the carrier liquid is selected from the group consisting of water, ethanol, benzyl alcohol, and ethyl acetate. 
     
     
         5 . The method of  claim 1 , wherein the soluble polymer is from about 0.5%-10% w/v of the film-forming agent. 
     
     
         6 . The method of  claim 1 , wherein the biological tissue is selected from the middle ear or the round window membrane of the inner ear. 
     
     
         7 . A method for treating a subject suffering from a disorder of the inner ear, comprising:
 injecting a composition to a biological tissue of the ear of the subject no more than one time in a 14 day period,   wherein the composition comprises a biologically-active agent dispersed in a film-forming agent,   wherein the film-forming agent comprises polyvinyl alcohol and a carrier liquid, wherein the polyvinyl alcohol has a molecular weight of from about 20,000 to 30,000 Daltons,   wherein the film-forming agent is free of solvent,   wherein the carrier liquid is capable of evaporating at a temperature of about 37° C.,   wherein the film-forming agent is capable of adhering to the biological tissue for an extended period of time,   and wherein said extended period of time is at least 14 days.   
     
     
         8 . The method of  claim 7 , further comprising, after injecting the composition to the biological tissue:
 allowing the at least a portion of the carrier liquid to evaporate, whereby the film-forming agent forms a film on the biological tissue.   
     
     
         9 . The method of  claim 7 , wherein the carrier liquid is selected from the group consisting of water, ethanol, benzyl alcohol, and ethyl acetate. 
     
     
         10 . The method of  claim 7 , wherein the PVA is from about 0.5%-10% w/v of the film-forming agent. 
     
     
         11 . The method of  claim 7 , wherein the biological tissue is selected from the middle ear or the round window membrane of the inner ear. 
     
     
         12 . A method for treating a subject suffering from sensorineural hearing loss, comprising:
 injecting a composition to a biological tissue of the ear of the subject no more than one time in a 14 day period,   wherein the composition comprises a biologically-active agent dispersed in a film-forming means.   
     
     
         13 . The method of  claim 12 , wherein the biological tissue is selected from the middle ear or the round window membrane of the inner ear.