Biochemically balanced peritoneal dialysis solutions

• US 7,011,855 B2
• Filed: 09/17/2001
• Issued: 03/14/2006
• Est. Priority Date: 07/01/1994
• Status: Expired due to Fees

• Current Assignee: Baxter International Inc.
• Original Assignee: Baxter International Inc.
• Inventors: Martis, Leo, Henderson, Lee W.
• Primary Examiner(s): KEYS, ROSALYND ANN
• Application Number:
  US09/955,248
• Publication Number:
  US 20020037329A1
• Time in Patent Office: 1,639 Days
• Field of Search: 514/557, 514/578, 210/645, 604/29, 424/665, 424/680, 424/682, 424/700, 424/717, 424/722
• US Class Current: 424/717
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/19 Carboxylic acids, e.g. valproic acid salicylic acid A61K31/60
• CPC Class Codes: A61K 31/7004 Monosaccharides having only carbon, hydrogen and oxygen atoms
• CPC Class Codes: A61K 33/00 Medicinal preparations containing inorganic active ingredients
• CPC Class Codes: A61K 33/10 Carbonates; Bicarbonates
• CPC Class Codes: A61K 33/14 Alkali metal chlorides; Alkaline earth metal chlorides
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61M 1/287 Dialysates therefor
• CPC Class Codes: A61P 13/12 of the kidneys
• CPC Class Codes: A61P 3/00 Drugs for disorders of the metabolism of the blood or the extracellular fluid A61P7/00
• CPC Class Codes: A61P 7/08 Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock artificial tears A61P27/04

Abstract

A peritoneal dialysis solution that is biochemically balanced to correct metabolic acidosis associated with chronic renal failure in a more physiological manner. The peritoneal dialysis solution has a physiological pH, e.g., pH of 7.0 to 7.4, and contains bicarbonate at a concentration that is found in normal blood. Additionally, the solution contains carbon dioxide at a partial pressure that is similar to partial pressure of carbon dioxide found in normal blood. The peritoneal dialysis solution also contains a weak acid with a pKa of less than 5.0.

Claims

1. A peritoneal dialysis solution including bicarbonate at a level of less than or equal to 30 mM/L, having a carbon dioxide partial pressure that is less than 60 mmHg and including a weak acid at a level of between approximately 15 mEq/L and approximately 20 mEq/L selected from the group consisting of:

lactate;

citrate;

isocitrate;

cis-aconitase;

α

-ketoglutarate;

succinate;

fumarate;

malate; and

oxaloacetate.

2. The peritoneal dialysis solution of claim 1 wherein bicarbonate is present in the solution at 25 mM/L.

3. The peritoneal dialysis solution of claim 1 wherein the carbon dioxide partial pressure of the solution is approximately the same as the carbon dioxide partial pressure of blood.

4. The peritoneal dialysis solution of claim 1 wherein the solution has a pH of approximately 7.0 to about 7.4.

5. The peritoneal dialysis solution of claim 1 wherein the weak acids have a pKa of <

5.0.

6. A peritoneal dialysis solution comprising:

Dextrose (hydrous) (g/dl) 

1.5–

4.25Sodium (mEq/L)100–

140Chloride (mEq/L) 

70–

110Calcium (mEq/L)0.0–

4.0Magnesium (mEq/L)0.0–

4.0Bicarbonate (mEq/L)20.0–

30.0Weak acid (mEq/L)10.0–

20.0

wherein the weak acid is chosen from the group consisting of;

lactate;

citrate;

isocitrate;

cis-aconitase;

α

-ketoglutarate;

succinate;

fumarate;

malate; and

oxaloacetate, the solution having a carbon dioxide partial pressure that is less than 60 mmHg.

7. The peritoneal dialysis solution of claim 6 wherein the solution has a pH of approximately 7.0 to about 7.4.

8. The peritoneal dialysis solution of claim 6 wherein the weak acids have a pKa of <

5.0.

9. The peritoneal dialysis solution of claim 6 wherein the carbon dioxide partial pressure of the solution is approximately the same as the carbon dioxide partial pressure of normal blood.

10. A peritoneal dialysis solution comprising:

Dextrose (hydrous) (g/dl) 

1.5–

4.25Sodium (mEq/L)100–

140Chloride (mEq/L) 

70–

110Calcium (mEq/L)0.0–

4.0Magnesium (mEq/L)0.0–

4.0Bicarbonate (mEq/L)20.0–

30.0Weak acid (mEq/L)10.0–

20.0

wherein the weak acid is chosen from the group consisting of;

lactate;

citrate;

isocitrate;

cis-aconitase;

α

-ketoglutarate;

succinate;

fumarate;

malate; and

oxaloacetate, and the solution has a carbon dioxide partial pressure that is substantially similar to the carbon dioxide partial pressure of a normal subject'"'"'s blood and the solution has a pH of approximately 7.0 to about 7.4.

11. A method for correcting metabolic acidosis in a dialysis patient suffering or likely to suffer from same comprising the step of:

administering to a patient a peritoneal dialysis solution that has a bicarbonate level and carbon dioxide partial pressure that are substantially similar to that found in the normal persons blood wherein the solution comprises;

Dextrose (hydrous) (g/dl) 

1.5–

4.25Sodium (mEq/L)100–

140Chloride (mEq/L) 

70–

110Calcium (mEq/L)0.0–

4.0Magnesium (mEq/L)0.0–

4.0Bicarbonate (mEq/L)20.0–

30.0Weak acid (mEq/L)10.0–

20.0

wherein the weak acid is chosen from the group consisting of;

lactate;

citrate;

isocitrate;

cis-aconitase;

α

-ketoglutarate;

succinate;

fumarate;

malate; and

oxaloacetate.

12. The method of claim 11 including the step of administering to the patient a weak acid that is present in the solution in an amount that offsets the daily hydrogen production of approximately 1 mEq/kg/day.

13. The method of claim 12 wherein the weak acid have a pKa of <

5.0.

14. The method of claim 11 wherein the solution has a pH of approximately 7.0 to about 7.4.

15. The method of claim 11 wherein the solution does not include lactate.