Method of making iron(III)gluconate complex

Abstract

The present invention refers to a method for making iron(III)gluconate complex, preferably alkali iron(III)gluconate complex. The method includes the following steps: (i) mixing a water soluble iron(III)salt in aqueous solution, simultaneously or in any desired sequence, with a member selected from gluconic acid, a water soluble salt of gluconic acid and combinations thereof, and a member selected from an alkali hydroxide, an alkali carbonate, an alkali hydrogen carbonate and combinations thereof, so that the reaction mixture has an acid value (pH-value) within the range of from 7.0 to 12, provided that when alkali hydroxide is used, gluconic acid or a water soluble salt of gluconic acid is provided at the beginning of the reaction or is added to the reaction mixture simultaneously with the alkali hydroxide; (ii) heating the reaction mixture until the iron(III)gluconate complex has formed; and (iii) adding an organic solvent which is miscible with water until the iron(III)gluconate complex is precipitated. The present invention also refers to pharmaceutical compositions including the iron(III)gluconate complex and methods of treating anemic conditions.

1 . The process for the preparation of sodium ferric gluconate complex in sucrose, comprising the steps of: 
 a) combining ferric chloride salt solution with alkaline earth metal and ammonium salts chosen from the group consisting of sodium carbonate, sodium bicarbonate, lithium carbonate, potassium carbonate, potassium bicarbonate, ammonium carbonate, ammonium bicarbonate and mixtures there of; to form the ferric oxyhydroxide;    b) combining ferric oxyhydroxide and sodium gluconate in solution to yield the sodium ferric gluconate complex; and    c) combining sodium ferric gluconate with sucrose in solution to yield the desired sodium ferric gluconate complex in sucrose.    
   
   
       2 . The process of  claim 1  in which the ferric chloride salt is ferric chloride hexahydrate.  
   
   
       3 . The process of  claim 1  in which the alkaline earth metal salt is sodium carbonate.