Process for the production of iron(III)hydroxide/dextran complexes and a sterile pharmaceutical solution containing them

Claim 1

A process for producing stable, sterile aqueous pharmaceutical solution for the treatment of iron deficiencies containing the iron(III)hydroxide/dextran complex comprising: (a) dissolving dextran having an average molecular weight of from 3,000 to 6,000 in water; (b) cooling the dextran solution to a temperature of less than 40° C.; (c) adding the cooled dextran solution to a solution of FeCl 3 at a temperature of less than 40° C. to form a mixed solution having a weight ratio of from 50 to 100 kg of iron ions per 100 kg of dextran; (d) adding from 2.0 to 2.6 vals of carbonate selected from the group consisting of alkali metal carbonates, ammonium carbonate and carbonates of organic bases inert to the reaction components to said mixed solution over a period of more than two hours; (e) adding an alkali metal hydroxide or ammonium hydroxide to the solution of step (d) to yield a suspension having a pH of at least about 10.5; (f) recovering the iron(III)/dextran complex; (g) dissolving said iron(III)/dextran complex in water to yield a stable solution having an iron content of at least 15% W/V.