Polymeric Devices for Controlled Release of Active Agents

Abstract

Polymeric devices for controlled release of an active agent of interest are provided. The active agent is provided within a biodegradable polymer system to supply a polymeric device for controlled release of the active agent. The polymer system is a copolymer or a polymer blend comprising a hydrophobic component and a hydrophilic component, and the polymer system does not form a hydrogel when contacted with, or immersed in an aqueous system, for example when the device is implanted in a subject. When the device is administered to a subject, for example, when it is implanted, the device releases the active agent in a controlled fashion without a lag period, or with a minimal lag period. Methods for producing the polymeric devices are also provided, as are methods of using the polymeric devices to provide for controlled release of an active agent in a subject.

1 . A polymeric device for controlled release of an active agent of interest, said device comprising
 a biodegradable polymer system selected from the group consisting of copolymers and polymeric blends comprising a hydrophobic component and a hydrophilic component; and   an active agent, wherein the polymer system does not form a hydrogel when the device is contacted with an aqueous system, and further wherein the device releases the agent without a lag period or with a minimal lag period.   
     
     
         2 . The device of  claim 1  wherein the active agent is present in an amount up to 40 wt %. 
     
     
         3 . The device of  claim 1 , wherein the active agent is a peptide. 
     
     
         4 . The device of  claim 3 , wherein the peptide is a therapeutic and/or prophylactic peptide selected from the group consisting of hormones, growth factors, neuroactive agents, melanotropic peptides, cell adhesion factors, cytokines, and biological response modifiers. 
     
     
         5 . The device of  claim 4 , wherein the peptide is a GnRH molecule or a GnRH analog. 
     
     
         6 . The device of  claim 5 , wherein the GnRH analog is selected from the group consisting of desorelin, tryptorelin, goserelin, and leuprolide. 
     
     
         7 . The device of  claim 1 , wherein polymer system is a copolymer comprising a hydrophobic component and a hydrophilic component. 
     
     
         8 . The device of  claim 1 , wherein polymer system is a blend of a hydrophobic polymer and a hydrophilic polymer. 
     
     
         9 . The device of  claim 1 , wherein the hydrophilic component is present in an amount of up to 25%. 
     
     
         10 . The device of  claim 1 , wherein the hydrophilic component is present in an amount of up to 15%. 
     
     
         11 . The device of  claim 1 , wherein the hydrophilic component is present in an amount of between 0.5 and 10 weight percent. 
     
     
         12 . The device of  claim 1 , wherein the polymer system is an AB copolymer wherein the A component is a copolymer of lactide, glycolide, or caprolactone, and the B component is a polyalkyleneglycol. 
     
     
         13 . The device of  claim 12 , wherein the B component is a polyalkyleneglycol at 1.25 weight percent and the hydrophobic polymer is poly(lactide-co-glycolide). 
     
     
         14 . The device of  claim 1 , wherein the active agent is distributed uniformly within the polymer. 
     
     
         15 . The device of  claim 1 , wherein the active agent is incorporated using a non-solvent process. 
     
     
         16 . The device of  claim 1 , wherein the device is formed by dry melt extrusion. 
     
     
         17 . The device of  claim 1 , wherein the device is formed by melt extrusion of the copolymer mixed with peptide. 
     
     
         18 . The device of  claim 1 , wherein the active agent is released with linear or near zero order release kinetics. 
     
     
         19 . The device of  claim 1 , wherein the polymer system comprises greater than 75 wt % hydrophobic polymer. 
     
     
         20 . The device of  claim 19 , wherein the polymer system comprises greater than 85 wt % hydrophobic polymer. 
     
     
         21 .- 56 . (canceled)