Oral insulin composition and methods of making and using thereof

Abstract

A method of lowering blood glucose in a mammal includes orally administering a therapeutically effective amount of crystallized dextran microparticles and insulin to the mammal to lower blood glucose of the mammal. The composition may be a one phase or a structured multi-phase composition for controlled release of insulin.

1 . An implant produced by providing a liquid composition comprising an aqueous solution of dextran with a molecular weight of 1.0 to 200 kDa at a concentration of 40-65% by weight to a mammal by introducing the liquid composition into the body of the mammal, thereby forming an implant in the body of the mammal. 
     
     
         2 . The implant of  claim 1 , wherein the liquid composition further comprises a therapeutic agent. 
     
     
         3 . The implant of  claim 2 , wherein the therapeutic agent is present at a concentration of 15-30% by weight. 
     
     
         4 . The implant of  claim 2 , wherein the therapeutic agent is a protein. 
     
     
         5 . The implant of  claim 1  or  2 , wherein the dextran is present at a concentration from 55-65% by weight. 
     
     
         6 . The implant of  claim 1  or  2 , wherein the liquid composition is introduced into the body of the mammal by injection. 
     
     
         7 . The implant of  claim 1  or  2 , wherein said liquid composition comprises a rehydrated freeze-dried dextran component. 
     
     
         8 . The implant of  claim 2 , wherein the therapeutic agent is insulin. 
     
     
         9 . A method of treating a disease or disorder in a mammal, comprising forming the implant of  claim 2  in the body of the mammal, wherein said implant releases the therapeutic agent into the body of the mammal. 
     
     
         10 . The method of  claim 9 , wherein the disease or disorder is diabetes. 
     
     
         11 . The method of  claim 9 , wherein the therapeutic agent is insulin. 
     
     
         12 . The method of  claim 9 , wherein the mammal is a human.