Method for iron delivery to a patient by transfer from dialysate

• US 5,906,978 A
• Filed: 06/05/1997
• Issued: 05/25/1999
• Est. Priority Date: 08/14/1996
• Status: Expired due to Fees

• Current Assignee: HemoCleanse, Inc.
• Original Assignee: HemoCleanse, Inc.
• Inventors: Ash, Stephen R.
• Primary Examiner(s): Schenkman, Leonard
• Application Number:
  US08/869,331
• Time in Patent Office: 719 Days
• Field of Search: 514/23, 514/502, 514/814, 424/648
• US Class Current: 514/23
• CPC Class Codes: A61K 33/26 Iron; Compounds thereof
• CPC Class Codes: A61M 1/1654 Dialysates therefor
• CPC Class Codes: A61M 1/287 Dialysates therefor

Abstract

The invention relates to methods and compositions for delivering iron to an iron-deficient patient, more particularly, to methods whereby an iron complex comprising divalent or trivalent ionic iron complexed with one or more low molecular weight anions is administered to a patient by transfer from dialysate. A complex selected according to the invention is non-polymeric; soluble in an aqueous medium; chemically stable, thereby preventing the dissociation of iron ions from the anions under conditions according to the invention; and can be well absorbed into blood and the living body. Also provided are dialysate compositions including therein an iron complex selected according to the invention, and dialysate concentrates which may be diluted to yield an inventive dialysate composition.

Claims

1. A method for delivering iron to blood comprising:

providing a dialysate having dissolved therein a complex of one or more divalent or trivalent iron ions and one or more anions, the complex having a molecular weight of less than about 50,000; and

dialyzing a patient with the dialysate to increase the level of iron in the patient'"'"'s blood.

2. The method according to claim 1, wherein the anion is an organic anion.

3. The method according to claim 1, wherein the organic anion has a molecular weight of less than about 12,000.

4. The method according to claim 3, wherein the complex is ferrous gluconate.

5. The method according to claim 1, wherein the molecular weight is less than about 12,000;

and wherein said dialyzing comprises dialyzing the blood extracorporeally with the dialysate.

6. The method according to claim 1, wherein said dialyzing comprises introducing the dialysate into the patient'"'"'s peritoneum.

7. The method according to claim 1, wherein the concentration of divalent or trivalent iron ions in the dialysate is at least about 50 μ

g/dl and the molecular weight of the complex is less than about 25,000.

8. A method for delivering iron to blood, comprising:

passing blood against a first side of a membrane; and

passing against a second side of the membrane an aqueous solution having dissolved therein an iron complex comprising one or more iron ions and one or more anions;

the complex having a molecular weight of less than about 12,000;

wherein the membrane is permeable to the complex; and

wherein the complex is delivered to the blood.

9. The method according to claim 8, wherein the complex has a molecular weight of less than about 5,000.

10. The method according to claim 8, wherein the complex is ferrous gluconate.

11. A method for delivering iron to a patient, comprising:

introducing a dialysate into a patient'"'"'s peritoneal cavity, the dialysate having dissolved therein a complex of one or more divalent or trivalent iron ions and one or more anions;

wherein the complex has a molecular weight of less than about 50,000.

12. The method according to claim 11, wherein the complex has a molecular weight of less than about 25,000.

13. The method according to claim 11, wherein the anion is an organic anion.

14. A method for the treatment of a patient to increase the level of iron in the patient'"'"'s bloodstream, which comprises performing dialysis on the patient with a dialysate which comprises a soluble, low molecular weight iron complex;

sodium;

magnesium;

calcium;

potassium;

chloride;

acetate and bicarbonate.

15. A method for delivering iron to blood comprising:

providing a dialysate having dissolved therein from about 0.008 to about 2 mg/dl ferrous gluconate; and

dialyzing a patient with the dialysate to increase the level of iron in the patient'"'"'s blood.

16. The method according to claim 15, wherein the dialysate further comprises from about 130 to about 150 mEq/L sodium, from about 0.4 to about 1.5 mEq/L magnesium, from about 2 to about 4 mEq/L calcium, from about 1 to about 3 mEq/L potassium, from about 90 to about 120 mEq/L chloride, from about 3 to about 5 mEq/L acetate and from about 30 to about 40 mEq/L bicarbonate.

17. A composition comprising an aqueous medium having dissolved therein sodium, magnesium, calcium, potassium, chloride, acetate, bicarbonate and an iron complex having a molecular weight of less than about 50,000.

18. The composition according to claim 17, further comprising a member selected from the group consisting of dextrose, a sorbent and a surfactant.

19. The composition according to claim 17, comprising from about 130 to about 150 mEq/L sodium, from about 0.4 to about 1.5 mEq/L magnesium, from about 2 to about 4 mEq/L calcium, from about 1 to about 3 mEq/L potassium, from about 90 to about 120 mEq/L chloride, from about 3 to about 5 mEq/L acetate, from about 30 to about 40 mEq/L bicarbonate and from about 1 to about 250 μ

g/dl iron as an iron complex having a molecular weight of less than about 50,000.

20. The composition according to claim 17, comprising from about 3900 to about 6000 mEq/L sodium, from about 12 to about 60 mEg/L magnesium, from about 60 to about 160 mEq/L calcium, from about 30 to about 120 mEq/L potassium, from about 2700 to about 4800 mEq/L chloride, from about 90 to about 200 mEq/L acetate, from about 900 to about 1600 mEq/L bicarbonate and from about 0.03 to about 10 mg/dl iron as an iron complex having a molecular weight of less than about 50,000.