Aqueous iron carbohydrate complexes, their production and medicaments containing them

Abstract

A water soluble iron carbohydrate complex obtainable from an aqueous solution of iron(III) salt and an aqueous solution of the oxidation product of one or more maltrodextrins using an aqueous hypochlorite solution at a pH-value within the alkaline range, where, when one maltodextrin is applied, its dextrose equivalent lies between 5 and 20, and when a mixture of several maltodextrins is applied, the dextrose equivalent of the mixture lies between 5 and 20 and the dextrose equivalent of each individual maltodextrin contained in the mixture lies between 2 and 40, process for its production and a medicament for the treatment and prophylaxis of iron deficiency conditions.

1 . Water soluble iron carbohydrate complex obtainable from an aqueous solution of iron (Ill) salt and an aqueous solution of the oxidation product of one or more maltodextrins using an aqueous hypochlorite solution at a pH-value within the alkaline range, where, when one maltodextrin is applied, its dextrose equivalent lies between 5 and 20, and when a mixture of several maltodextrins is applied, the dextrose equivalent of the mixture lies between 5 and 20 and the dextrose equivalent of each individual maltodextrin contained in the mixture lies between 2 and 40. 
     
     
         2 . A process for producing an iron carbohydrate complex according to  claim 1 , wherein one or more maltodextrins are oxidized in an aqueous solution at an alkaline pH-value using an aqueous hypochlorite solution and the obtained solution is reacted with an aqueous solution of an iron (Ill) salt, where, when one maltodextrin is applied, its dextrose equivalent lies between 5 and 20, and when a mixture of several maltodextrins is applied, the dextrose equivalent of the mixture lies between 5 and 20 and the dextrose equivalent of each individual maltodextrins contained in the mixture lies between 2 and 40. 
     
     
         3 . The process according to  claim 2 , characterized in that the oxidation of the maltodextrin or the maltodextrins is carried out in the presence of bromide ions. 
     
     
         4 . The process according to  claim 2 , characterized in that the iron (Ill) chloride is used as the iron (Ill) salt. 
     
     
         5 . The process according to  claim 2 , characterized in that the oxidized maltodextrin and the iron (Ill) salt are mixed to form an aqueous solution having a pH- value so low that no hydrolysis of the iron (Ill) salt occurs, whereafter the pH is raised to 5 to 12 by the addition of a base. 
     
     
         6 . The process according to  claims 3  to  5 , characterized in that the reaction is carried out at a temperature of 15° C. up to boiling point for 15 minutes up to several hours. 
     
     
         7 . The water soluble iron carbohydrate complex according to  claim 1  formulated as a medicament in aqueous solution form. 
     
     
         8 . The water soluble iron carbohydrate complex according to  claim 7  formulated for parenteral or oral application. 
     
     
         9 . A method of treating or preventing iron deficiency, the method comprising administering a water soluble iron carbohydrate complex of  claim 1  for treatment or prophylaxis of iron deficiency. 
     
     
         10 . The method of  claim 9 , wherein the water soluble iron carbohydrate complex is formulated as a medicament in aqueous solution form for treatment or prophylaxis of iron deficiency. 
     
     
         11 . The water soluble iron carbohydrate complex according to  claim 1  for treatment or prophylaxis of iron deficiency.