Patent ID: 8691776

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) providing a reaction mixture at reaction conditions, said reaction mixture having a pH and formed from: (i) water; (ii) at least one compound selected from the group consisting of glucose, sodium gluconate and sucrose; (iii) at least one ferric salt selected from the group consisting of ferric chloride, ferric nitrate, ferric acetate, ferric sulfate, and double ferric salts; and (iv) a basic reactant selected from the group consisting of alkali metal hydroxides, ammonium hydroxide, alkaline earth metal hydroxides, carbonates of alkali metals and mixtures thereof; wherein said reaction conditions include: (a) a molar ratio of compound (ii) to ferric salt (iii) of about 30:1 to about 1:30; and (b) the reaction mixture is at a first temperature of about 20° C. up to 85° C.; (2) modifying said reaction conditions to the extent required in order to obtain at least the following pH and temperature by: (x) adding a base selected from the group consisting of alkali metal hydroxides, ammonium hydroxide, alkaline earth metal hydroxides, carbonates of alkali metals and mixtures thereof, the same or different as in (1)(iv) above, in an amount effective to increase the pH of said reaction mixture to at least 5.0; and (y) heating said reaction mixture to a second temperature and for a time, said second temperature greater than said first temperature and at least 40° C.; provided said reaction conditions as modified are sufficient for the reaction mixture to reach a final pH of at least 7.0 and to form said iron-saccharidic complex having an absolute weight average molecular weight of about 25,000 Daltons or more.