Process for producing an iron-dextran compound, iron-dextran compound produced according to said process, pharmaceutical composition for prophylaxis or treatment of iron-deficiency and use of said compound for the preparation of a parenterally administrable pharmaceutical composition

Abstract

In a process for producing an iron-dextran compound for use in parenteral treatment of iron-deficiency in humans or animals a stable compound of desired relatively low molecular weight is obtained by using first hydrogenation and then oxidation to convert reducing terminal groups on the dextran molecules before reaction with the iron. By varying the ratio of hydrogenated groups to oxygenated groups the average molecular weight of the resulting iron-dextran compound can be varied.

Description

BACKGROUND OF THE INVENTION AND PRIOR ART[0001] Iron-deficiency anemia has been described as one of the most common--possibly the most common--pathological conditions among humans when viewed on a global basis. Also in modern farm-breeding of pigs and other domestic animals iron-deficiency anemia is a problem unless suitable prophylactic measures are taken.[0002] Although iron-deficiency anemia can often be prevented or cured by oral administration of iron-containing preparations, it is in many cases preferred to use parenterally administrable iron preparations to avoid variations in bioavailability of oral administrations and to ensure effective administration.[0003] Therefore, iron-containing preparations for parenteral use, i.e. subcutaneous, intramuscular or intravenous administration, have for many years been at the disposal of the veterinary or human medical practitioner.[0004] Various iron-containing substances have been used or suggested as components in parenterally injecta...

AI Technical Summary

Problems solved by technology

Also in modern farm-breeding of pigs and other domestic animals iron-deficiency anemia is a problem unless suitable prophylactic measures are taken.

In spite of the several attempts to improve iron-dextran preparations for treatment of anemia, as reflected in the above patents, the preparations prepared according to the state of the art still have some drawbacks.

This is a result of the fact that in some patients the preparations may cause delayed hypersensitivity, or severe anaphylactic side effects, resulting e.g. in dyspnea, hypotension, shock and death.

Besides, several of the prior art preparations are not able to meet current requirements as to stability.

Moreover, the promoting action of the commercially available iron-dextran preparations on the heamoglobin synthesis in the patients receiving said preparations presents itself rather late after administration, and reestablishment of desired haemoglobin levels takes place more slowly than often desired.

However, if the proportion of oxidized groups in the dextran is too high the iron-dextran will have insufficient stability.

This is because any remaining reducing groups react with the ferric compounds when contacted therewith to form ferro compounds which by parenterally administration are more toxic than ferric compounds.