Formulation for controlled release of drugs by combining hydrophilic and hydrophobic agents

Abstract

Combinations of hydrophilic and hydrophobic entities in a biodegradable sustained release implant are shown to modulate each other's rate of release. Formulations of a therapeutically active agent and modulator provide substantially constant rate of release for an extended period of time.

1 - 9 . (Canceled)  
     
     
         10 . A biodegradable implant for placement in an eye, comprising: a steroid and a polylactic acid polyglycolic acid (PLGA) copolymer, wherein the steroid makes up between about 1 percent by weight and about 80 percent by weight of the implant, and wherein the implant releases at least about 10% of the steroid within 1 week.  
     
     
         11 . The implant of  claim 10 , wherein the steroid is dexamethasone.  
     
     
         12 . The implant of  claim 11 , wherein the dexamethasone makes up about 50 percent by weight of the implant.  
     
     
         13 . The implant of  claim 10 , wherein the steroid is located within a polylactic acid polyglycolic acid (PLGA) copolymer matrix.  
     
     
         14 . The implant of  claim 10 , wherein the implant releases at least about 10% of the steroid within 1 week when measured under infinite sink condition in vitro.  
     
     
         15 . The implant of  claim 10 , wherein the implant releases at least about 20% of the steroid within about 3 weeks when measured under infinite sink conditions in vitro.  
     
     
         16 . The implant of  claim 10 , wherein the implant releases at least about 60% of the steroid within about 4 weeks when measured under infinite sink conditions in vitro.  
     
     
         17 . The implant of  claim 10 , which includes no release modifier.  
     
     
         18 . The implant of  claim 10 , wherein the copolymer is effective in controlling the release of the steroid from the implant.  
     
     
         19 . A biodegradable implant for placement in an eye, comprising: an extruded mixture of a steroid and a biodegradable polylactic acid polyglycolic acid (PLGA) copolymer, wherein the steroid makes up between about 1 percent by weight and about 80 percent by weight of the biodegradable implant.  
     
     
         20 . The implant of  claim 19 , wherein the steroid is dexamethasone.  
     
     
         21 . The implant of  claim 19 , which includes no release modifier.  
     
     
         22 . The implant of  claim 19 , wherein the copolymer is effective in controlling the release of the steroid from the implant.