Buffered compositions for dialysis

Abstract

Acid concentrates, and dialysate compositions prepared therefrom, contain citric acid and an effective amount of a buffering agent selected from acetate and/or lactate. The buffering agent allows a physiologically acceptable amount of citrate to maintain the desired pH of the dialysate.

What is claimed is: 
     
         1 .- 15 . (canceled) 
     
     
         16 . A buffered dialysate composition consisting essentially of treated water; chloride at a concentration ranging from about 20 to about 200 mEq/L; citrate at a concentration ranging from about 0.5 to about 30 mEq/L, wherein the citrate is present in a form of one or more of citric acid, sodium dihydrogen citrate, disodium hydrogen citrate, trisodium citrate, trisodium citrate dihydrate, potassium dihydrogen citrate, dipotassium hydrogen citrate, calcium citrate, and magnesium citrate; a buffer comprising a buffering anion selected from acetate and lactate at a concentration ranging from about 0.2 to about 0.5 mEq/L; base including bicarbonate; and at least one physiologically-acceptable cation selected from a group consisting of hydrogen, sodium, potassium, calcium, magnesium, and combinations thereof. 
     
     
         17 . (canceled) 
     
     
         18 . The dialysate composition of  claim 16  wherein the base further includes at least one of carbonate, lactate salt, citrate salt, and acetate salt at a concentration ranging from about 25 to about 45 mEq/L. 
     
     
         19 . (canceled) 
     
     
         20 . The dialysate composition of  claim 16 , further consisting essentially of a sugar selected from glucose, poly(glucose) and fructose, at a concentration of less than about 45 g/L. 
     
     
         21 . The dialysate composition of  claim 16  wherein the water meets or exceeds the purity requirements established by AAMI for dialysate and all other components have at least USP-grade purity. 
     
     
         22 . The dialysate composition of  claim 16  wherein the pH is about 5 to about 8.5 at a temperature of about 25° C. to about 40° C. 
     
     
         23 .- 24 . (canceled) 
     
     
         25 . The dialysate composition of  claim 16  consisting essentially of chloride at a concentration ranging from about 60 to about 120 mEq/L; citrate at a concentration ranging from about 2 to about 3 mEq/L, wherein the citrate is present in a form of one or more of citric acid, sodium dihydrogen citrate, disodium hydrogen citrate, trisodium citrate, trisodium citrate dihydrate, potassium dihydrogen citrate, dipotassium hydrogen citrate, calcium citrate, and magnesium citrate; acetate at a concentration ranging from about 0.2 to about 0.5 mEq/L; bicarbonate at a concentration ranging from about 25 to about 45 mEq/L; at least one physiologically-acceptable cation selected from hydrogen, sodium at a concentration ranging from about 70 to about 150 mEq/L, potassium at a concentration of less than about 5 mEq/L, calcium at a concentration of less than about 5 mEq/L, and magnesium at a concentration of less than about 2 mEq/L; and glucose at a concentration of less than about 45 g/L, where the composition meets or exceeds the AAMI-quality standard set for dialysate. 
     
     
         26 .- 56 . (canceled) 
     
     
         57 . A dialysate composition consisting essentially of treated water; chloride at a concentration ranging from about 20 to about 200 mEq/L; citrate at a concentration ranging from about 0.5 to about 30 mEq/L, wherein the citrate is present in a form of one or more of citric acid, sodium dihydrogen citrate, disodium hydrogen citrate, trisodium citrate, trisodium citrate dihydrate, potassium dihydrogen citrate, dipotassium hydrogen citrate, calcium citrate, and magnesium citrate; acetate or lactate at a concentration ranging from about 0.01 to about 4.5 mEq/L; bicarbonate at a concentration ranging from about 25 to about 45 mEq/L; and at least one physiologically-acceptable cation. 
     
     
         58 . A dialysate composition consisting essentially of treated water; chloride at a concentration ranging from about 20 to about 200 mEq/L; citrate at a concentration ranging from about 0.5 to about 30 mEq/L, wherein the citrate is present in a form of one or more of citric acid, sodium dihydrogen citrate, disodium hydrogen citrate, trisodium citrate, trisodium citrate dihydrate, potassium dihydrogen citrate, dipotassium hydrogen citrate, calcium citrate, and magnesium citrate; acetate or lactate at a concentration ranging from about 0.01 to about 4.5 mEq/L; bicarbonate at a concentration ranging from about 25 to about 45 mEq/L; and at least one physiologically-acceptable cation selected from hydrogen, sodium at a concentration ranging from about 60 to about 190 mEq/L, potassium at a concentration of less than about 5 mEq/L, calcium at a concentration of less than about 5 mEq/L and magnesium at a concentration of less than about 2 mEq/L. 
     
     
         59 . A dialysate composition consisting essentially of treated water; chloride at a concentration ranging from about 20 to about 200 mEq/L; citrate at a concentration ranging from about 0.5 to about 30 mEq/L, wherein the citrate is present in a form of one or more of citric acid, sodium dihydrogen citrate, disodium hydrogen citrate, trisodium citrate, trisodium citrate dihydrate, potassium dihydrogen citrate, dipotassium hydrogen citrate, calcium citrate, and magnesium citrate; acetate or lactate at a concentration ranging from about 0.01 to about 4.5 mEq/L; bicarbonate at a concentration ranging from about 25 to about 45 mEq/L; and at least one physiologically-acceptable cation selected from hydrogen, sodium at a concentration ranging from about 60 to about 190 mEq/L, potassium at a concentration of less than about 5 mEq/L, calcium at a concentration of less than about 5 mEq/L and magnesium at a concentration of less than about 2 mEq/L; and glucose at a concentration of less than about 45 g/L.