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Claims for Patent: 7,754,702

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Claims for Patent: 7,754,702

Title:Methods and compositions for administration of iron
Abstract: The present invention generally relates to treatment of iron-related conditions with iron carbohydrate complexes. One aspect of the invention is a method of treatment of iron-related conditions with a single unit dosage of at least about 0.6 grams of elemental iron via an iron carbohydrate complex. The method generally employs iron carbohydrate complexes with nearly neutral pH, physiological osmolarity, and stable and non-immunogenic carbohydrate components so as to rapidly administer high single unit doses of iron intravenously to patients in need thereof.
Inventor(s): Helenek; Mary Jane (Brookville, NY), Tokars; Marc L. (Douglassville, PA), Lawrence; Richard P. (Calverton, NY)
Assignee: Luitpold Pharmaceuticals, Inc. (Shirley, NY)
Application Number:11/620,986
Patent Claims: 1. A method of treating a disease, disorder, or condition characterized by iron deficiency or dysfunctional iron metabolism resulting in reduced bioavailability of dietary iron, comprising administering to a subject in need thereof an iron carbohydrate complex in a single dosage unit of at least about 0.6 grams of elemental iron; wherein the iron carbohydrate complex is selected from the group consisting of an iron carboxymaltose complex, an iron mannitol complex, an iron polymaltose complex, an iron gluconate complex, and an iron sorbitol complex; and the iron carbohydrate complex has a substantially non-immunogenic carbohydrate component and substantially no cross reactivity with anti-dextran antibodies wherein said disease, disorder or condition is not Restless Leg Syndrome.

2. The method of claim 1 wherein the disease, disorder, or condition is anemia.

3. The method of claim 2 wherein the anemia is iron deficiency anemia.

4. The method of claim 3 wherein the iron deficiency anemia is associated with chronic blood loss; acute blood loss; pregnancy; childbirth; childhood development; psychomotor and cognitive development in children; breath holding spells; heavy uterine bleeding; menstruation; chronic recurrent hemoptysis; idiopathic pulmonary siderosis; chronic internal bleeding; gastrointestinal bleeding; parasitic infections; chronic kidney disease; dialysis; surgery or acute trauma; and chronic ingestion of alcohol, chronic ingestion of salicylates, chronic ingestion of steroids; chronic ingestion of non-steroidial anti-inflammatory agents, or chronic ingestion of erythropoiesis stimulating agents.

5. The method of claim 2 wherein the anemia is anemia of chronic disease.

6. The method of claim 5 wherein the chronic disease is selected from the group consisting of rheumatoid arthritis; cancer; Hodgkins leukemia; non-Hodgkins leukemia; cancer chemotherapy; inflammatory bowel disease; ulcerative colitis thyroiditis; hepatitis; systemic lupus erythematosus; polymyalgia rheumatica; scleroderma; mixed connective tissue disease; Sojgren's syndrome; congestive heart failure/cardiomyopathy; and idiopathic geriatric anemia.

7. The method of claim 2 wherein the anemia is due to impaired iron absorption or poor nutrition.

8. The method of claim 7, wherein the anemia is associated with Crohn's Disease; gastric surgery; ingestion of drug products that inhibit iron absorption; or chronic use of calcium.

9. The method of claim 1 wherein the disease, disorder, or condition is selected from the group consisting of blood donation; hair loss; and attention deficit disorder.

10. The method of claim 1 wherein the single dosage unit of elemental iron is at least about 0.7 grams.

11. The method of claim 10 wherein the single dosage unit of elemental iron is at least about 0.8 grams.

12. The method of claim 11 wherein the single dosage unit of elemental iron is at least about 0.9 grams.

13. The method of claim 12 wherein the single dosage unit of elemental iron is at least about 1.0 grams.

14. The method of claim 13 wherein the single dosage unit of elemental iron is at least about 1.5 grams.

15. The method of claim 14 wherein the single dosage unit is at least about 2.0 grams.

16. The method of claim 15 wherein the single dosage unit of elemental iron is at least about 2.5 grams.

17. The method of claim 1 wherein the single dosage unit of elemental iron is administered in about 15 minutes or less.

18. The method of claim 17 wherein the single dosage unit of elemental iron is administered in about 10 minutes or less.

19. The method of claim 18, wherein the single dosage unit of elemental iron is administered in about 5 minutes or less.

20. The method of claim 19, wherein the single dosage unit of elemental iron is administered in about 2 minutes or less.

21. The method of claim 1 wherein the iron carbohydrate complex has a pH between about 5.0 to about 7.0; physiological osmolarity; an iron core size no greater than about 9 nm; a mean diameter particle size no greater than about 35 nm; and a blood half-life of between about 10 hours to about 20 hours.

22. The method of claim 1 wherein the iron carbohydrate complex contains about 24% to about 32% elemental iron; contains about 25% to about 50% carbohydrate; and has a molecular weight of about 90,000 daltons to about 800,000 daltons.

23. The method of claim 1 wherein the iron carbohydrate complex is an iron carboxymaltose complex.

24. The method of claim 23 wherein the iron carboxymaltose complex contains about 24% to about 32% elemental iron, about 25% to about 50% carbohydrate, and is about 100,000 daltons to about 350,000 daltons.

25. The method of claim 23 wherein the iron carboxymaltose complex is obtained from an aqueous solution of iron (III) salt and an aqueous solution of the oxidation product of one or more maltodextrins using an aqueous hypochlorite solution at a pH value within the alkaline range, wherein, when one maltodextrin is applied, its dextrose equivalent lies between about 5 and about 20, and when a mixture of several maltodextrins is applied, the dextrose equivalent lies between about 5 and about 20 and the dextrose equivalent of each individual maltodextrin contained in the mixture lies between about 2 and about 20.

26. The method of claim 23 wherein: the iron carboxymaltose complex has a chemical formula of [FeO.sub.x(OH).sub.y(H.sub.2O).sub.z].sub.n[{(C.sub.6H.sub.10O.sub.5).sub- .m(C.sub.6H.sub.12O.sub.7)}.sub.1].sub.k, where n is about 103, m is about 8, I is about 11, and k is about 4; contains about 28% elemental iron; and has a molecular weight of about 150,000 Da.

27. The method of claim 23 wherein the iron carboxymaltose complex is polynuclear iron (III)-hydroxide 4(R)-(poly-(1.fwdarw.4)-O-.alpha.-glucopyranosyl)-oxy-2(R),3(S),5(R),6-te- trahydroxy-hexanoate.

28. The method of claim 1 wherein the iron carbohydrate complex is an iron polyglucose sorbitol carboxymethyl ether complex.

29. The method of claim 28 wherein the iron polyglucose sorbitol carboxymethyl ether complex is a polyglucose sorbitol carboxymethyl ether-coated non-stoichiometric magnetite complex.

30. The method of claim 1 wherein the iron carbohydrate complex comprises an iron core with a mean iron core size of no greater than about 9 nm.

31. The method of claim 30 wherein the mean iron core size is at least about 1 nm but no greater than about 9 nm.

32. The method of claim 31 wherein the mean iron core size is at least about 3 nm but no greater than about 7 nm.

33. The method of claim 32 wherein the mean iron core size is at least about 4 nm but not greater than about 5 nm.

34. The method of claim 1 wherein mean size of a particle of the iron carbohydrate complex is no greater than about 35 nm.

35. The method of claim 34 wherein the particle mean size is no greater than about 30 nm.

36. The method of claim 35 wherein the particle mean size is no greater than about 25 nm.

37. The method of claim 36 wherein the particle mean size is no greater than about 20 nm.

38. The method of claim 37 wherein the particle mean size is no greater than about 15 nm.

39. The method of claim 38 wherein the particle mean size is no greater than about 10 nm.

40. The method of claim 39 wherein the particle mean size is at least 6 nm but no greater than about 7 nm.

41. The method of claim 1 wherein the iron carbohydrate complex is administered parenterally.

42. The method of claim 41 wherein the iron carbohydrate complex is administered intravenously.

43. The method of claim 42 wherein the iron carbohydrate complex is intravenously infused.

44. The method of claim 43 wherein the single unit dose of iron carbohydrate complex is intravenously infused at a concentration of about 1000 mg elemental iron in about 200 ml to about 300 ml of diluent.

45. The method of claim 44 wherein the single unit dose of iron carbohydrate complex is intravenously infused at a concentration of about 1000 mg elemental iron in about 250 ml of diluent.

46. The method of claim 44 wherein the single unit dose of iron carbohydrate complex is intravenously infused at a concentration of about 1000 mg elemental iron in about 215 ml of diluent.

47. The method of claim 42 wherein the iron carbohydrate complex is intravenously injected as a bolus.

48. The method of claim 47 wherein the single unit dose of iron carbohydrate complex is intravenously injected as a bolus at a concentration of about 1000 mg elemental iron in about 200 ml to about 300 ml of diluent.

49. The method of claim 48 wherein the single unit dose of iron carbohydrate complex is intravenously injected as a bolus at a concentration of about 1000 mg elemental iron in about 250 ml of diluent.

50. The method of claim 48 wherein the single unit dose of iron carbohydrate complex is intravenously injected as a bolus at a concentration of about 1000 mg elemental iron in about 215 ml of diluent.

51. The method of claim 41 wherein the iron carbohydrate complex is administered intramuscularly.

52. The method of claim 51 wherein the iron carbohydrate complex is intramuscularly injected at a concentration of about 500 mg elemental iron in less than about 10 ml diluent.

53. The method of claim 1 further comprising a second administration of said iron carbohydrate complex upon recurrence of at least one symptom of the disease, disorder, or condition.

54. The method of claim 1 further comprising a second administration of said iron carbohydrate complex after 1 day to 12 months after the first administration.

55. A method of treating a disease, disorder, or condition characterized by iron deficiency or dysfunctional iron metabolism resulting in reduced bioavailability of dietary iron, comprising: intravenously administering to a subject in need thereof an iron carboxymaltose complex in a single dosage unit of at least about 1000 mg of elemental iron in about 200 ml to about 300 ml of diluent in about 5 minutes or less; wherein the iron carboxymaltose complex comprises an iron core with a mean iron core size of at least about 1 nm but no greater than about 9 nm; wherein mean size of a particle of the iron carboxymaltose complex is no greater than about 35 nm; wherein the iron carboxymaltose complex is administered intravenously infused or intravenously injected at a concentration of about 1000 mg elemental iron in about 200 ml to about 300 ml of diluent.

56. The method of claim 55 wherein the iron carboxymaltose complex is obtained from an aqueous solution of iron (III) salt and an aqueous solution of the oxidation product of one or more maltodextrins using an aqueous hypochlorite solution at a pH value within the alkaline range, wherein, when one maltodextrin is applied, its dextrose equivalent lies between about 5 and about 20, and when a mixture of several maltodextrins is applied, the dextrose equivalent lies between about 5 and about 20 and the dextrose equivalent of each individual maltodextrin contained in the mixture lies between about 2 and about 20.

57. The method of claim 55 wherein the iron carboxymaltose complex is polynuclear iron (III)-hydroxide 4(R)-(poly-(1.fwdarw.4)-O-.alpha.-glucopyranosyl)-oxy-2(R),3(S),5(R),6-te- trahydroxy-hexanoate.
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