Polymer-based sustained release device

Abstract

This invention relates to compositions for the sustained release of biologically active polypeptides, and methods of forming and using said compositions, for the sustained release of biologically active polypeptides. The sustained release compositions of this invention comprise a biocompatible polymer having dispersed therein, a biologically active polypeptide and a sugar.

1 . An injectable composition for sustained release of a glucoregulatory polypeptide, comprising:
 a biocompatible polymer having the glucoregulatory polypeptide dispersed therein so as to be present al about 3 to 10% (w/w) of the weight of the composition, and a sugar dispersed therein so as lobe present at about 0.1 to 5% (w/w) of the weight of the composition,   wherein the injectable composition is free from additional ingredients that alter the rate of release of the glucoregulatory polypeptide from the injectable composition, and   wherein sustained release of the glucoregulatory polypeptide occurs over at least a period of about one week.   
     
     
         2 . The injectable composition of  claim 1 , wherein the sustained release of the glucoregulatory polypeptide occurs over at least a period of about two weeks. 
     
     
         3 . The injectable composition of  claim 1 , wherein the sustained release of the glucoregulatory polypeptide occurs over at least a period of about three weeks. 
     
     
         4 . The injectable composition of  claim 1 , wherein the sustained release of the glucoregulatory polypeptide occurs over at least a period of about four weeks. 
     
     
         5 . The injectable composition of  claim 1 , wherein the glucoregulatory polypeptide is exendin-4. 
     
     
         6 . The injectable composition of  claim 2 , wherein the glucoregulatory polypeptide is exendin-4. 
     
     
         7 . The injectable composition of  claim 3 , wherein the glucoregulatory polypeptide is exendin-4. 
     
     
         8 . The injectable composition of  claim 4 , wherein the glucoregulatory polypeptide is exendin-4. 
     
     
         9 . A method of treating a patient suffering from Type 2 diabetes, comprising administering a therapeutically effective amount of the injectable composition of  claim 1 . 
     
     
         10 . The method of  claim 9 , wherein the glucoregulatory polypeptide is exendin-4.