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Claims for Patent: 5,624,668

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Claims for Patent: 5,624,668

Title: Iron dextran formulations
Abstract:Ferric oxyhydroxide-dextran compositions for treating iron deficiency having ellipsoidal particles with a preferred molecular weight range of about 250,000 to 300,000 daltons.
Inventor(s): Lawrence; Richard P. (Baiting Hollow, NY), Lange; Ralf A. (Amagansett, NY), Wu; Chin (Shirley, NY), Helenek; Mary J. (Syosset, NY)
Assignee: Luitpold Pharmaceuticals, Inc. (Shirley, NY)
Application Number:08/536,984
Patent Claims: 1. An iron-dextran composition for treating iron deficiency comprising an aqueous colloidal suspension or solution of a ferric oxyhydroxide-dextran complex in a physiologically acceptable carrier, said complex having a beta-FeO(OH) core and an average molecular weight range of about 100,000 to 600,000 daltons and a substantially uniform size distribution, said complex further having been treated under alkaline conditions with an oxidized low molecular weight carbohydrate stabilizing agent and having an increased plasma residence time as compared with iron-dextran compositions that have not been so treated.

2. The composition of claim 1, wherein said stabilizing agent is selected from the group consisting of mannitol, sorbitol, glycerol, inositol, ascorbate, dextrin, cellulose, carboxymethyl cellulose, starch, hydroxyethylstarch, heparin, dextran, dextran sulfate and carboxylmethylated dextran.

3. The composition of claim 1, wherein said average molecular weight is about 150,000 to 350,000 daltons.

4. The composition of claim 1, wherein said average molecular weight is about 250,000 to 300,000 daltons.

5. The composition of claim 1, wherein said complex has the shape of an ellipsoid.

6. The composition of claim 5, wherein said ellipsoid has an average length of about 25 to 45 nanometers and a width of about 3.5 to 5.5 nanometers.

7. The composition of claim 6, wherein said ellipsoid has an average length of about 31.5 to 36.5 nanometers and a width of about 4 to 5 nanometers.

8. The composition of claim 1, wherein the iron component of said complex comprises an initial iron dextran preparation having particles with a molecular weight ranging from about 100,000 to 600,000 daltons and the low molecular weight stabilizing agent component of said complex comprises an oxidized dextran of low molecular weight ranging from about 1,000 to 15,000 daltons.

9. The composition of claim 8, wherein said oxidized dextran has a molecular weight of about 6,000 daltons.

10. The composition of claim 8, wherein the pH is adjusted to about 5.2 to 6.5.

11. The composition of claim 2, wherein said stabilizing agent is dextran.

12. The composition of claim 1, wherein said core is formed during the neutralization of an acidic ferric chloride/dextran solution with an alkali.

13. A method for making an iron dextran composition for treating iron deficiency, comprising the steps of:

preparing an iron dextran suspension, said suspension comprised of iron dextran particles having a beta-FeO(OH) core;

purifying said composition by the removal of contaminants and by-products inconsistent with administration to mammalian patients;

reacting said iron dextran complex under alkaline conditions with an oxidized low molecular weight carbohydrate stabilizing agent; and

purifying the iron dextran composition in the form of iron-dextran complexes, said complexes having an increased plasma residence time as compared with iron-dextran compositions that have not been so treated.

14. A method for reducing anemia in a human or animal subject comprising the administration of a pharmaceutically acceptable dose of the composition of claim 1.

15. A method for reducing anemia in a human or animal subject comprising the administration of a pharmaceutically acceptable dose of the composition of claim 11.

16. A stable injectable iron dextran solution prepared by the method of claim 13.

17. The composition of claim 13, wherein said stabilizing agent is selected from the group consisting of mannitol, sorbitol, glycerol, inositol, ascorbate, dextrin, cellulose, carboxymethyl cellulose, starch, hydroxyethylstarch, heparin, dextran, dextran sulfate and carboxylmethylated dextran.

18. The method of claim 17, wherein said stabilizing agent is dextran.

19. The method of claim 15, wherein said dextran has an average molecular weight in the range from about 1,000 to 15,000 daltons.

20. The method of claim 16, wherein said dextran has an average molecular weight of about 6,000 daltons.

21. The method of claim 13, wherein the pH of the composition is adjusted to about 5.2 to 6.5.

22. The method of claim 13, wherein said complexes have an average molecular weight in the range from about 150,000 to 350,000 daltons.

23. The method of claim 22 wherein said average molecular weight is about 250,000 to 300,000 daltons.

24. The method of claim 17, wherein said complexes have the shape of an ellipsoid.

25. The method of claim 24, wherein said ellipsoid has an average length of about 25 to 45 nanometers and a width of about 3.5 to 5.5 nanometers.

26. The method of claim 25, wherein said ellipsoid has an average length of about 31.5 to 36.5 nanometers and a width of about 4 to 5 nanometers.

27. An iron-dextran composition produced by the process of claim 13.

28. The composition of claim 27, wherein said composition is formulated for parenteral human administration in a physiologically acceptable carrier.
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