Manufacture, formulation and dosing of apraglutide

Abstract

The present disclosure relates to methods of making, formulating and administering GLP-2 analogs.

What is claimed is: 
     
         1 . A sodium salt of apraglutide having a purity of no less than 95%, wherein apraglutide has the following structure: 
       
         
           
           
               
               
           
         
       
     
     
         2 . The sodium salt of apraglutide of  claim 1 , wherein the sodium salt of apraglutide has a purity of no less than 97%. 
     
     
         3 . The sodium salt of apraglutide of  claim 1 , wherein the sodium salt of apraglutide comprises no more than 3% of a Des-Gly 4  apraglutide impurity. 
     
     
         4 . The sodium salt of apraglutide of  claim 1 , wherein the sum of Aspartimide 3  apraglutide, Asp 33 -OH apraglutide and Des-Ser 7  apraglutide impurities in the sodium salt of apraglutide is no more than 2%. 
     
     
         5 . The sodium salt of apraglutide of  claim 1 , wherein the sodium salt of apraglutide comprises no more than 2% of a [Trp 25 , 2-(2,4,6-trimethoxyphenyl)] apraglutide impurity. 
     
     
         6 . The sodium salt of apraglutide of  claim 1 , wherein the sodium salt of apraglutide comprises no more than 1.5% of a β-Asp 3  apraglutide impurity. 
     
     
         7 . The sodium salt of apraglutide of  claim 6 , wherein the sodium salt of apraglutide comprises no more than 1% of a β-Asp 3  apraglutide impurity. 
     
     
         8 . The sodium salt of apraglutide of  claim 1 , wherein the sodium salt of apraglutide comprises no more than 1% of a D-His apraglutide impurity. 
     
     
         9 . The sodium salt of apraglutide of  claim 1 , wherein the sodium salt of apraglutide comprises:
 no more than 1% of a Asp 33 -OH apraglutide impurity,   no more than 1% of a Des-Ser 7  apraglutide impurity,   no more than 1% of a D-Aspartimide 3  apraglutide impurity,   no more than 1% of a [Trp 25 , 2-(2,4,6-trimethoxyphenyl)] apraglutide impurity, and   wherein the sum of Des-Gly 4  apraglutide and Aspartimide 3  apraglutide impurities in the sodium salt of apraglutide is no more than 1%.   
     
     
         10 . The sodium salt of apraglutide of  claim 1 , wherein the sodium salt of apraglutide is provided as a lyophilized powder.