FIELD: medicaments.
SUBSTANCE: present invention provides water-soluble iron-carbohydrate derivative complexes which are suitable for the therapy of iron deficiency states, and the preparation thereof, medicaments comprising them, and the use thereof in the prophylaxis or therapy of iron deficiency states. The medicaments are suitable in particular for parenteral administration. A water-soluble iron-carbohydrate derivative complex obtained from the reaction of an aqueous iron (III) salt solution and (b) an aqueous solution of the product of the oxidation and subsequent derivatization of one or more maltodextrins, wherein the oxidation is carried out with an aqueous hypochlorite solution at a pH value in the alkaline range, wherein when one maltodextrin is used its dextrose equivalent is from 5 to 20 and when a mixture of a plurality of maltodextrins is used the dextrose equivalent of the mixture is from 5 to 20 and the dextrose equivalent of the individual maltodextrins in the mixture is from 2 to 40, and the subsequent derivatization is carried out with a suitable reagent. The process for the preparation of the iron-carbohydrate complex, wherein one or more maltodextrins is oxidized in aqueous solution, at an alkaline pH value, with an aqueous hypochlorite solution, the subsequent derivatization is carried out with a suitable reagent, and the resulting solution is reacted with the aqueous solution of an iron (III) salt, wherein when one maltodextrin is used its dextrose equivalent is from 5 to 20 and when a mixture of a plurality of maltodextrins is used the dextrose equivalent of the mixture is from 5 to 20 and the dextrose equivalent of the individual maltodextrins in the mixture is from 2 to 40.
EFFECT: most derivatised maltodextrin ligands exhibit increased stability towards enzymatic degradation by amylase as compared with underivatised maltodextrin, which can promote retarded and uniform degradation of the iron-maltodextrin derivative complexes according to the invention in the body.
15 cl, 11 tbl, 45 ex
