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 . A method of preparing a composition for controlled release of a therapeutic agent, comprising:
 providing an aqueous solution of dextran with a molecular weight of 1.0 to 200 kDa, wherein the dextran is at a concentration of 40-65% by weight of said aqueous solution;   forming a dextran matrix from the aqueous solution at a temperature ranging from 20-90° C.; and   adding a therapeutic agent to at least a portion of the dextran matrix, thereby producing a dextran matrix with the therapeutic agent.   
     
     
         2 . The method of  claim 1 , wherein the molecular weight of the dextran is 20 to 75 kDa 
     
     
         3 . The method of  claim 1 , wherein the dextran is present in said solution at a concentration of 55-65% by weight. 
     
     
         4 . The method of  claim 1 , wherein water is eliminated from at least a portion of the matrix by drying. 
     
     
         5 . The method of  claim 4 , wherein said drying is performed at a temperature ranging from 20-90° C. 
     
     
         6 . The method of  claim 1 , wherein the therapeutic agent is dissolved in the aqueous solution. 
     
     
         7 . The method of  claim 1 , wherein the therapeutic agent is added at a concentration of 15-30% by weight in the aqueous solution. 
     
     
         8 . The method of  claim 1 , wherein the therapeutic agent is insulin. 
     
     
         9 . A pharmaceutical composition comprising a dextran matrix prepared by the process of  claim 1 . 
     
     
         10 . The pharmaceutical composition of  claim 9 , wherein the composition is a tablet or capsule. 
     
     
         11 . The pharmaceutical composition of  claim 9 , wherein the therapeutic agent is insulin. 
     
     
         12 . The pharmaceutical composition of  claim 9 , wherein the therapeutic agent is insulin and the composition is a tablet or capsule.