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Claims for Patent: 7,612,109

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Claims for Patent: 7,612,109

Title:Water-soluble iron-carbohydrate complexes, production thereof, and medicaments containing said complexes
Abstract: 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, process for its production and medicament for the treatment and prophylaxis of iron deficiency conditions.
Inventor(s): Geisser; Peter (St. Gallen, CH), Philipp; Erik (Wittenbach, CH), Richle; Walter (Gossau, CH)
Assignee: Vifor (International) AG (St. Gallen, CH)
Application Number:10/531,895
Patent Claims: 1. A water soluble iron carbohydrate complex having a weight average molecular weight (Mw) of 80,000 to 400,000, comprising the reaction product of: (a) an aqueous solution of an iron (III) salt and (b) an aqueous solution of the oxidation product of (i) at least one maltodextrin and (ii) an aqueous hypochlorite solution at an alkaline pH, wherein, when one maltodextrin is present, the maltodextrin has a dextrose equivalent of between 5 and 20, and wherein, when a mixture of more than one maltodextrin is present, the dextrose equivalent of each individual maltodextrin is between 2 and 40, and the dextrose equivalent of the mixture is between 5 and 20.

2. A medicament comprising an aqueous solution of the iron carbohydrate complex of claim 1.

3. The medicament of claim 2, wherein the medicament is formulated for parenteral or oral application.

4. The water soluble iron carbohydrate complex of claim 1, wherein the iron carbohydrate complex has a weight average molecular weight (Mw) of 80,000 to 350,000.

5. The water soluble iron carbohydrate complex of claim 1, wherein the iron carbohydrate complex has a weight average molecular weight (Mw) of 80,000 to 300,000.

6. A process for producing a water soluble iron carbohydrate complex having a weight average molecular weight (Mw) of 80,000 to 400,000, comprising the steps of: (a) oxidizing at least one maltodextrin in an aqueous solution at an alkaline pH with an aqueous hypochlorite solution to form an oxidized maltodextrin solution, and (b) contacting the oxidized maltodextrin solution with an aqueous solution of an iron (III) salt, wherein, when one maltodextrin is present, the maltodextrin has a dextrose equivalent of between 5 and 20, and wherein, when a mixture of more than one maltodextrin is present, the dextrose equivalent of each individual maltodextrin is between 2 and 40, and the dextrose equivalent of the mixture is between 5 and 20.

7. The process of claim 6, wherein the iron (III) salt is iron (III) chloride.

8. The process of claim 7, wherein step (b) is carried out at a pH of 2 or less to form a final solution, and the process further comprises (c) raising the pH of the final solution to a value in the range of 5 to 12.

9. The process of claim 7, wherein step (b) is carried out at a temperature of from 15.degree. C. to the boiling point for 15 minutes up to several hours.

10. The process of claim 6, wherein step (b) is carried out at a pH of 2 or less to form a final solution, and the process further comprises (c) raising the pH of the final solution to a value in the range of 5 to 12.

11. The process of claim 10, wherein step (b) is carried out at a temperature of from 15.degree. C. to the boiling point for 15 minutes up to several hours.

12. The process of claim 6, wherein step (a) is carried out in the presence of bromide ions.

13. The process of claim 12, wherein step (b) is carried out at a temperature of from 15.degree. C. to the boiling point for 15 minutes up to several hours.

14. The process of claim 12, wherein the iron (III) salt is iron (III) chloride.

15. The process of claim 14, wherein step (b) is carried out at a pH of 2 or less to form a final solution, and the process further comprises (c) raising the pH of the final solution to a value in the range of 5 to 12.

16. The process of claim 12, wherein step (b) is carried out at a pH of 2 or less to form a final solution, and the process further comprises (c) raising the pH of the final solution to a value in the range of 5 to 12.

17. The process of claim 6, wherein step (b) is carried out at a temperature of from 40.degree. C. to 60.degree. C.

18. The process of claim 6, wherein step (b) is carried out at a temperature of from 50.degree. C. to the solution boiling point.

19. A process for producing a water soluble iron carbohydrate complex having a weight average molecular weight (Mw) of 80,000 to 400,000, comprising the steps of: (a) oxidizing at least one maltodextrin in an aqueous solution at a pH in the range of 8 to 12 and a temperature in the range of 15 to 40.degree. C., for 10 minutes to 4 hours with an aqueous hypochlorite solution to form an oxidized maltodextrin solution, (b) contacting the oxidized maltodextrin solution with an aqueous solution of an iron (III) salt and (c) raising the pH of the oxidized maltodextrin solution and iron (III) salt to a value in the range of 5 to 14, wherein, when one maltodextrin is present, the maltodextrin has a dextrose equivalent of between 5 and 20, and wherein, when a mixture of more than one maltodextrin is present, the dextrose equivalent of each individual maltodextrin is between 2 and 40, and the dextrose equivalent of the mixture is between 5 and 20.

20. The process of claim 19, wherein at least one of the following steps are carried out: (1) step (a) is carried out at a pH in the range of 9 to 11; (2) the temperature at which step (a) is carried out is in the range of 25 to 35.degree. C.; (3) step (a) is carried out for 1 to 1.5 hours.

21. The process of claim 19, wherein (b) is carried out at a pH of 2 or less.

22. The process of claim 19, wherein in (c), the pH is raised to a value in the range of 11 to 14.

23. The process of claim 19, further comprising after (c), (d) reducing the pH of the solution to a value in the range of 5 to 6.

24. The process of claim 23, wherein, simultaneous with (c), the solution temperature is or maintained in, the range of 15 to 70.degree. C.

25. The process of claim 23, wherein simultaneous with (d), the solution temperature, if it is not already at least 50.degree. C., is raised to 50.degree. C., followed by gradually raising the temperature to the solution boiling point.

26. The process of claim 25, further comprising after (d), (e) cooling the solution to room temperature.

27. The process of claim 26, further comprising after (e), (f) adjusting the pH to a value in the range of 6 to 7.
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