Stable iron oligosaccharide compound
AssigneePharmacosmos Holding A/S
InventorHans ANDREASEN
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Abstract
The invention relates to an iron oligosaccharide compound with improved stability comprising a hydrogenated oligosaccharide in stable association with ferric oxyhydroxide, the content of dimer saccharide in said hydrogenated oligosaccharide being 2.9% by weight or less, based on the total weight of the hydrogenated oligosaccharide. In further aspects is provided a process for preparing said compound as well as the use of said compound for preparation of a composition for treatment of iron deficiency anaemia.
Claims21
1-34. (canceled)
An iron oligosaccharide compound comprising a hydrogenated oligosaccharide in stable association with ferric oxyhydroxide, the hydrogenated oligosaccharide having a weight average molecular weight (Mw) of less than 3,000 Daltons, characterized in that the content of dimer saccharide in said hydrogenated oligosaccharide is 2.9% by weight or less, based on the total weight of the hydrogenated oligosaccharide.
A process for preparing an iron oligosaccharide compound, comprising the steps of:
- (a) hydrolysing a polysaccharide so as to reduce its molecular weight, (b) hydrogenating the resulting oligosaccharide to convert functional aldehyde groups into alcohol groups,
- (c) fractioning the hydrogenated oligosaccharide according to molecular weight, so that the purified fraction has a weight average molecular weight equal to or less than 3,000 Daltons,
- (d) combining the resultant fractionated hydrogenated oligosaccharide as an aqueous solution with at least one water-soluble ferric salt,
- (e) adding base to the resulting aqueous solution to form ferric hydroxide, and
- (f) heating the resultant basic solution to transform the ferric hydroxide into ferric oxyhydroxide in association with said oligosaccharide;
- characterized in that step (c) comprises a procedure of purification by one or more membrane processes having a cut-off value between 340 and 800 Daltons, which procedure is continued until the content of dimer saccharide in the purified fraction of oligosaccharide has been reduced to 2.9% by weight or less, based on the total weight of the hydrogenated oligosaccharide.
A method for prophylaxis or treatment of iron-deficiency anaemia in an animal or human subject, comprising parenteral or oral administration of a compound according to claim to a said animal or human subject.
A hydrogenated oligosaccharide having a weight average molecular weight (Mw) of less than 3,000 Daltons, characterized in that said hydrogenated oligosaccharide has a dimer saccharide content of 2.9% by weight or less, based on the total weight of the hydrogenated oligosaccharide.
A process for preparing a hydrogenated oligosaccharide, which process comprises the steps of:
- (a) hydrolysing a polysaccharide so as to reduce its molecular weight, (b) hydrogenating the resulting oligosaccharide to convert functional aldehyde groups into alcohol groups, and
- (c) fractioning the hydrogenated oligosaccharide according to molecular weight, so that the purified fraction has a weight average molecular weight equal to or less than 3,000 Daltons, characterized in that step (c) comprises a procedure of purification by one or more membrane processes having a cut-off value between 340 and 800 Daltons, which procedure is continued until the content of dimer saccharide in the purified fraction of oligosaccharide has been reduced to 2.9% by weight or less, based on the total weight of the hydrogenated oligosaccharide.
Dependencies are inferred from the claim text.