An iron-dextran compound for use as a component in a...

C - Chemistry – Metallurgy – 08 – B

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C08B 37/02 (2006.01) A61K 33/26 (2006.01) A61K 47/48 (2006.01) A61P 3/02 (2006.01)

Patent

CA 2322633

An iron-dextran compound for parenteral treatment of iron-deficiency anemia comprises hydrogenated dextran having a weight average molecular weight (Mw) between 700 and 1,400 Daltons, preferably approximately 1,000 Daltons, a number average molecular weight (Mn) of 400 to 1,400 Daltons and wherein 90 % by weight of the dextran has molecular weights less than 2,700 Daltons and the Mw of the 10 % by weight fraction of the dextran having the highest molecular weights is below 3,200 Daltons, said hydrogenated dextran having been subjected to purification by membrane processes having a cut-off value between 340 and 800 Daltons, in stable association with ferric oxyhydroxide. The compound is produced by using membrane processes to eliminate dextrans of higher molecular weights than approximately 2,700 Daltons and membrane processes to remove saccharides of molecular weights below approximately 340 Daltons from hydrogenated dextran before precipitating ferric hydroxide in the presence of said dextran followed by heat treatment and purification.

L'invention concerne un composé fer-dextrane destiné au traitement parentéral de l'anémie ferriprive. Ce composé comprenant du dextrane hydrogéné, a un poids moléculaire moyen pondéral (Mw) compris entre 700 et 1400 daltons, de préférence, environ 1000 daltons, et un poids moléculaire moyen numéral (Mn) de 400 à 1400 daltons. 90 % en poids du dextrane présente des poids moléculaires inférieurs à 2700 daltons, et le Mw de la fraction de 10 % en poids du dextrane qui a les poids moléculaires les plus élevés est inférieur à 3200 daltons. Ce dextrane hydrogéné a été soumis à une purification par traitement à membrane ayant un seuil d'arrêt compris entre 340 et 800 daltons, en association stable avec un oxyhydroxyde ferrique. On produit ce composé en utilisant des traitements à membrane pour éliminer les dextranes de poids moléculaires plus élevés qu'environ 2700 daltons, et des traitements à membrane pour éliminer les saccharides de poids moléculaires inférieurs à environ 340 daltons à partir de dextrane hydrogéné avant précipitation de l'hydroxyde ferrique en présence de ce dextrane, suivie d'un traitement thermique et d'une purification.

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