Method for iron delivery to a patient by transfer from dialysate

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.

1 - 23 . (canceled)  
     
     
         24 . An aqueous composition, comprising: 
 water;    a plurality of electrolytes dissolved in the water, the electrolytes having a concentration in the water of from about 256.4 mEq/L to about 324.5 mEq/L, and the electrolytes proportioned for dialysis of a patient; and    an iron complex dissolved in the water, the complex comprising one or more divalent or trivalent iron ions and one or more anions and having a molecular weight of less than about 50,000, the iron complex having a concentration in the water to provide an iron concentration of from about 1 to about 250 μg/dl.    
     
     
         25 . The composition in accordance with  claim 24 , further comprising glucose dissolved in the water.  
     
     
         26 . The composition in accordance with  claim 24 , wherein said plurality of electrolytes comprises a plurality of members selected from the group consisting of sodium ions, chloride ions and acetate ions.  
     
     
         27 . The composition in accordance with  claim 24 , wherein said plurality of electrolytes comprises a plurality of members selected from the group consisting of magnesium ions, potassium ions, sodium ions, chloride ions, acetate ions and bicarbonate ions.  
     
     
         28 . The composition in accordance with  claim 24 , further comprising calcium ions dissolved in the water.  
     
     
         29 . The composition in accordance with  claim 24 , further comprising a member selected from the group consisting of dextrose, a sorbent and a surfactant dissolved or dispersed in the water.  
     
     
         30 . A method for making an aqueous composition useful as a dialysate, comprising, dissolving into water (i) a plurality of electrolytes in an amount effective to provide an electrolyte concentration in the water of from about 256.4 mEq/L to about 324.5 mEq/L, the electrolytes proportioned for dialysis of a patient and (ii) an iron complex comprising one or more divalent or trivalent iron ions and one or more anions and having a molecular weight of less than about 50,000 in an amount effective to provide an iron concentration in the water of from about 1 to about 250 μg/dl, to provide an aqueous composition.  
     
     
         31 . The method in accordance with  claim 30 , further comprising dissolving glucose in the water.  
     
     
         32 . The method in accordance with  claim 30 , wherein the plurality of electrolytes comprises a plurality of members selected from the group consisting of sodium ions, chloride ions and acetate ions.  
     
     
         33 . The method in accordance with  claim 30 , wherein the plurality of electrolytes comprises a plurality of members selected from the group consisting of magnesium ions, potassium ions, sodium ions, chloride ions, acetate ions and bicarbonate ions.  
     
     
         34 . The method in accordance with  claim 30 , further comprising dissolving calcium ions into the water.  
     
     
         35 . The method in accordance with  claim 30 , further comprising introducing into the water a member selected from the group consisting of dextrose, a sorbent and a surfactant.  
     
     
         36 . A method for making an aqueous composition useful as a dialysate, comprising: 
 providing a first aqueous solution of electrolytes, the electrolytes having a concentration in the solution of from about 256.4 mEq/L to about 324.5 mEq/L and the electrolytes being proportioned for dialysis of a patient; and    introducing into the first solution an iron complex comprising one or more divalent or trivalent iron ions and one or more anions and having a molecular weight of less than about 50,000, to provide a second aqueous solution useful as a dialysate, the second aqueous solution having an iron concentration of from about 1 to about 250 μg/dl.    
     
     
         37 . The method in accordance with  claim 36 , wherein the complex is introduced in a predetermined amount, the amount being selected based upon the iron needs of a given patient.  
     
     
         38 . An aqueous composition, comprising: 
 water;    a plurality of electrolytes dissolved in the water; and    an iron complex dissolved in the water, the complex comprising one or more divalent or trivalent iron ions and one or more anions and having a molecular weight of less than about 50,000;    wherein the electrolytes and the iron complex have concentrations in the water whereby the composition is effective for dilution to provide a dialysate having an electrolyte concentration of from about 256.4 mEq/L to about 324.5 mEq/L and an iron concentration of from about 1 to about 250 μg/dl.    
     
     
         39 . The composition in accordance with  claim 38 , further comprising glucose dissolved in the water.  
     
     
         40 . The composition in accordance with  claim 38 , wherein said plurality of electrolytes comprises a plurality of members selected from the group consisting of sodium ions, chloride ions and acetate ions.  
     
     
         41 . The composition in accordance with  claim 38 , wherein said plurality of electrolytes comprises a plurality of members selected from the group consisting of magnesium ions, potassium ions, sodium ions, chloride ions, acetate ions and bicarbonate ions.  
     
     
         42 . The composition in accordance with  claim 38 , further comprising calcium ions dissolved in the water.  
     
     
         43 . The composition in accordance with  claim 38 , further comprising a member selected from the group consisting of dextrose, a sorbent and a surfactant dissolved or dispersed in the water.  
     
     
         44 . The composition in accordance with  claim 38 , wherein the electrolytes have a concentration in the water of from about 7692 mEq/L to about 12,980 mEq/L.  
     
     
         45 . A method for making an aqueous composition useful as a dialysate concentrate, comprising, dissolving into water (i) a plurality of electrolytes and (ii) an iron complex comprising one or more divalent or trivalent iron ions and one or more anions and having a molecular weight of less than about 50,000, to provide an aqueous composition; 
 wherein the electrolytes and the iron complex have concentrations in the water whereby the composition is effective for dilution to provide a dialysate having an electrolyte concentration of from about 256.4 mEq/L to about 324.5 mEq/L and an iron concentration of from about 1 to about 250 μg/dl.    
     
     
         46 . The method in accordance with  claim 45 , wherein the electrolytes have a concentration in the water of from about 7692 mEq/L to about 12,980 mEq/L and wherein the iron complex has a concentration in the water effective to provide an iron concentration in the water of from about 0.03 to about 10 mg/dl.  
     
     
         47 . The method in accordance with  claim 45 , further comprising dissolving glucose in the water.  
     
     
         48 . The method in accordance with  claim 45 , wherein the plurality of electrolytes comprises a plurality of members selected from the group consisting of sodium ions, chloride ions and acetate ions.  
     
     
         49 . The method in accordance with  claim 45 , wherein the plurality of electrolytes comprises a plurality of members selected from the group consisting of magnesium ions, potassium ions, sodium ions, chloride ions, acetate ions and bicarbonate ions.  
     
     
         50 . The method in accordance with  claim 45 , further comprising dissolving calcium ions into the water.  
     
     
         51 . The method in accordance with  claim 45 , further comprising introducing into the water a member selected from the group consisting of dextrose, a sorbent and a surfactant.  
     
     
         52 . A method for making an aqueous composition useful as a dialysate concentrate, comprising: 
 providing a first aqueous solution of electrolytes, the electrolytes having a concentration in    the solution of from about 7692 mEq/L to about 12,980 mEq/L; and    introducing into the first solution an iron complex comprising one or more divalent or trivalent iron ions and one or more anions and having a molecular weight of less than about 50,000, to provide a second aqueous solution useful as a dialysate concentrate, the second aqueous solution having an iron concentration of from about 0.03 to about 10 mg/dl.    
     
     
         53 . An aqueous composition, comprising: 
 water;    a plurality of electrolytes dissolved in the water, the electrolytes proportioned for dialysis of a patient; and    an iron complex dissolved in the water, the complex comprising one or more divalent or trivalent iron ions and one or more anions and having a molecular weight of less than about 50,000, the iron complex having a concentration in the water to provide an iron concentration of from about 1 to about 250 μg/dl.    
     
     
         54 . The aqueous composition in accordance with  claim 53 , wherein the aqueous composition is substantially hypertonic.  
     
     
         55 . The aqueous composition in accordance with  claim 53 , wherein the electrolytes are proportioned to prevent excessive ion removal from a patient's blood during dialysis of the blood with the composition.  
     
     
         56 . The aqueous composition in accordance with  claim 53 , wherein the iron complex comprises ferrous gluconate.