AN IRON-DEXTRAN COMPOUND FOR USE AS A COMPONENT IN A THERAPEUTICAL COMPOSITION FOR PROPHYLAXIS OR TREATMENT OF IRON-DEFICIENCY, A PROCESS FOR PRODUCING SAID IRON-DEXTRAN COMPOUND AND USE OF SAID COMPOUND FOR THE PREPARATION OF A PARENTERALLY....

摘要

The present invention relates to a iron dextran compound used as a parenterally administered pharmaceutical composition for preventing or treating iron deficiency in humans and animals. It is an object of the present invention to provide a hydrogenated dextran having a molecular weight (Mw) of from 700 to 1400 Daltons, preferably about 1000 Daltons, having a number (Mn) of 400-1000 Daltons, and having a molecular weight of less than 2700 Daltons in 90% of the dextran, with a maximum molecular weight of 10%. % dextran fraction weight average (Mw) of less than 3200 Dalton and purified by hydrogenated dextran membrane process with a nickel release value of 340 to 800 Dalton, providing a stable association with iron (III) oxide hydroxide. In the manufacture of the compound, a membrane method is used to remove the higher than 2700 Daltons and 340-800 Dalton hydrated dextran fractions, before saccharification of iron (III) hydroxide in the presence of dextran followed by heat treatment and purification. HE