Patent ID: 7964568

Claim:
A process for the preparation of a high molecular weight iron-saccharidic complex, said complex suitable for parenteral administration in human or veterinary medicine, comprising: (1) contacting in a substantially aqueous medium in order to form a reaction mixture having a pH: (i) at least one compound selected from the group consisting of monosaccharide sugars, oligosaccharide sugars containing up to about ten monosaccharide sugars linked together, sugar derivatives and mixtures thereof; with (ii) an aqueous solution, aqueous colloid, hydrosol or mixtures thereof comprising Fe(III) ion in the presence of (OH) − ion produced in situ from a ferric salt that is substantially fully reacted with a basic reactant; wherein: (a) the molar ratio of (i):(ii) is about 30:1 to about 1:30; and (b) the temperature of said mixture is about 20° C. to about 75° C.; (2) adding a base to increase the pH of said mixture to a complex assembly point; and (3) thereafter heating said mixture for a period of time sufficient to form said iron-saccharidic complex having an absolute weight average molecular weight of about 75,000 Daltons or more; and further comprising the addition, to the reaction mixture prior to the iron-saccharidic complex achieving its final molecular weight, of at least one sugar or sugar derivative molecular weight moderating additive in one or more of steps (1), (2) or (3) in an amount sufficient to cause the molecular weight of the high molecular weight iron-saccharidic complex to be lower than it would otherwise be in the absence of said additional amount; provided that the additive is different from the compound originally used in step (1)(i); and wherein said sugar derivatives: (a) are saccharides selected from the group consisting of acids, salts, methyl esters, acetates, amines, alcohols and mixtures thereof; and (b) substantially exclude polysaccharides.