Aqueous iron carbohydrate complexes, their production and medicaments containing them
A water soluble iron carbohydrate complex obtainable from an aqueous solution of iron(III) salt and an aqueous solution of the oxidation product of one or more maltrodextrins using an aqueous hypochlorite solution at a pH-value within the alkaline range, where, when one maltodextrin is applied, its dextrose equivalent lies between 5 and 20, and when a mixture of several maltodextrins is applied, the dextrose equivalent of the mixture lies between 5 and 20 and the dextrose equivalent of each individual maltodextrin contained in the mixture lies between 2 and 40, a process for its production and a medicament for the treatment and prophylaxis of iron deficiency conditions.
1. An iron (III) carbohydrate complex comprising at least one oxidized maltodextrin and the weight average molecular weight of the iron (III) carbohydrate complex is 80 kDa to 400 kDa, wherein said at least one maltodextrin prior to oxidation has a dextrose equivalent between 5 and 20, and when a mixture of several maltodextrins is applied, the dextrose equivalent is between 5 and 20 and the dextrose equivalent of each individual maltodextrin contained in the mixture is between 2 and 40.
2. The iron (III) carbohydrate complex of claim 1 , wherein 80% to 100% of one aldehyde group per molecule of maltodextrin are oxidized.
3. The iron (III) carbohydrate complex of claim 1 , wherein the oxidized maltodextrin is obtained by oxidation of maltodextrin in an aqueous hypochlorite solution.
4. The iron (III) carbohydrate complex of claim 1 suitable for administration as therapy or prophylaxis for an iron deficiency condition.
5. The iron (III) carbohydrate complex of claim 1 suitable for parenteral administration as a medicament to an animal in need thereof.
6. The iron (III) carbohydrate complex of claim 1 suitable for parenteral administration as a medicament to an animal in need thereof in the form of a single dose of 500 mg to 1000 mg iron.
7. The iron (III) carbohydrate complex of claim 1 in the form of a powder.
8. An aqueous solution of the iron (III) carbohydrate complex of claim 1 .
9. The aqueous solution of the iron (III) carbohydrate complex of claim 8 suitable for intravenous administration as a medicament to an animal in need thereof.
10. The aqueous solution of the iron (III) carbohydrate complex of claim 8 having an iron content of 1% weight/volume of the solution to 20% weight/volume of the solution.
11. The aqueous solution of the iron (III) carbohydrate complex of claim 9 having an iron content of 1% weight/volume of the solution to 20% weight/volume of the solution.
12. The aqueous solution of the iron (III) carbohydrate complex of claim 8 that has been sterilized at a temperature of at least 121° C.
13. The aqueous solution of the iron (III) carbohydrate complex of claim 10 that has been sterilized at a temperature of at least 121° C.
14. The aqueous solution of the iron (III) carbohydrate complex of claim 11 that has been sterilized at a temperature of at least 121° C.
15. The aqueous solution of the iron (III) carbohydrate complex of claim 8 that is free of preservatives.
16. The aqueous solution of the iron (III) carbohydrate complex of claim 10 that is free of preservatives.
17. The aqueous solution of the iron (III) carbohydrate complex of claim 11 that is free of preservatives.
18. The aqueous solution of the iron (III) carbohydrate complex of claim 14 that is free of preservatives.
19. An iron (III) carbohydrate complex comprising at least one oxidized maltodextrin and the weight average molecular weight of the iron (III) carbohydrate complex is 118 kDa to 400 kDa, wherein said at least one maltodextrin prior to oxidation has a dextrose equivalent between 5 and 20, and when a mixture of several maltodextrins is applied, the dextrose equivalent is between 5 and 20 and the dextrose equivalent of each individual maltodextrin contained in the mixture is between 2 and 40.
20. The iron (III) carbohydrate complex of claim 19 , wherein 80% to 100% of one aldehyde group per molecule of maltodextrin are oxidized.
21. The iron (III) carbohydrate complex of claim 19 , wherein the oxidized maltodextrin is obtained by oxidation of maltodextrin in an aqueous hypochlorite solution.
22. The iron (III) carbohydrate complex of claim 19 suitable for administration as therapy or prophylaxis for an iron deficiency condition.
23. The iron (III) carbohydrate complex of claim 19 suitable for parenteral administration as a medicament to an animal in need thereof.
24. The iron (III) carbohydrate complex of claim 19 suitable for parenteral administration as a medicament to an animal in need thereof in the form of a single dose of 500 mg to 1000 mg iron.
25. The iron (III) carbohydrate complex of claim 19 in the form of a powder.
26. An aqueous solution of the iron (III) carbohydrate complex of claim 19 .
27. The aqueous solution of the iron (III) carbohydrate complex of claim 26 suitable for intravenous administration as a medicament to an animal in need thereof.
28. The aqueous solution of the iron (III) carbohydrate complex of claim 26 having an iron content of 1% weight/volume of the solution to 20% weight/volume of the solution.
29. The aqueous solution of the iron (III) carbohydrate complex of claim 27 having an iron content of 1% weight/volume of the solution to 20% weight/volume of the solution.
30. The aqueous solution of the iron (III) carbohydrate complex of claim 26 that has been sterilized at a temperature of at least 121° C.
31. The aqueous solution of the iron (III) carbohydrate complex of claim 28 that has been sterilized at a temperature of at least 121° C.
32. The aqueous solution of the iron (III) carbohydrate complex of claim 29 that has been sterilized at a temperature of at least 121° C.
33. The aqueous solution of the iron (III) carbohydrate complex of claim 26 that is free of preservatives.
34. The aqueous solution of the iron (III) carbohydrate complex of claim 28 that is free of preservatives.
35. The aqueous solution of the iron (III) carbohydrate complex of claim 29 that is free of preservatives.
36. The aqueous solution of the iron (III) carbohydrate complex of claim 32 that is free of preservatives.