Solution for peritoneal dialysis

• US 6,277,815 B1
• Filed: 10/30/1998
• Issued: 08/21/2001
• Est. Priority Date: 10/31/1997
• Status: Expired due to Term

• Current Assignee: Fresenius Medical Care Deutschland GmbH (Fresenius Medical Care AG)
• Original Assignee: Fresenius Medical Care Deutschland GmbH (Fresenius Medical Care AG)
• Inventors: Knerr, Thomas
• Primary Examiner(s): Gitomer, Ralph
• Assistant Examiner(s): KHARE, DEVESH
• Application Number:
  US09/183,225
• Time in Patent Office: 1,026 Days
• Field of Search: 514/2, 514/23, 514/53, 514/54, 424/676
• US Class Current: 514/5.5
• 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 33/10 Carbonates; Bicarbonates
• CPC Class Codes: A61K 33/14 Alkali metal chlorides; Alkaline earth metal chlorides
• CPC Class Codes: A61M 1/287 Dialysates therefor
• CPC Class Codes: A61M 1/3458 having electrolytes not present in the dialysate
• 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 solution for peritoneal dialysis or for infusion comprises two single solutions which, after heat sterilization, are brought together and dispensed, with the first single solution containing calcium ions, additional electrolytic salts and glucose in an osmotically effective concentration and the second single solution containing bicarbonate and a weak acid with pKa<5. To provide a biocompatible solution, in particular for use as a peritoneal dialysis solution, the first single solution is acidified with a physiologically compatible acid to a pH of below 3.2. The second single solution contains bicarbonate only in a proportion which does not exceed 10 mmol/l.

Claims

1. A solution for peritoneal dialysis or infusion comprising:

a first single solution comprising calcium ions, additional electrolytic salts and glucose in an osmotically effective concentration, the first single solution being acidified with a physiologically compatible acid to a pH of below 3.2; and

a second single solution comprising bicarbonate and the salt of a weak acid with a pKa<

5, the bicarbonate of the second single solution not exceeding a concentration of 10 mmol/l;

wherein the first and second single solutions are brought together after heat sterilization to form a dispensable finished solution.

2. The solution as recited in claim 1 wherein the first single solution has a pH I of 2.8 to 3.2 and the second single solution has a pH of 8 to 8.5, the first and second single solutions being brought together at a ratio of about 1 to 1, by weight, so that the finished solution has a pH of approximately 7.2 to 7.4.

3. The solution as recited in claim 2 wherein the first single solution has a pH of 3.0.

4. The solution as recited in claim 1 wherein the first single solution includes sodium ions, magnesium ions, H⁺ excess ions and chloride ions.

5. The solution as recited in claim 1 wherein the second solution contains hydrocarbonate ions and sodium salts of weak acids selected from the group consisting of pyruvate and lactate.

6. The solution as recited in claim 1 wherein the physiologically compatible acid is hydrochloric acid.

7. The solution as recited in claim 1 wherein the first single solution comprises constituents in concentrations as follows:

8. The solution as recited in claim 1 wherein the second single solution comprises the constituents in the concentrations as follows:

9. The solution as recited in claim 7 wherein the first single solution comprises the constituents in the concentrations as follows:

10. The solution as recited in claim 8 wherein the second single solution comprises constituents in concentrations as follows:

11. The solution as recited in claim 1 wherein the two single solutions are stored separately in a double-chamber bag before being brought together.

12. The solution of claim 5 wherein the second solution contains hydrocarbonate ions and sodium α

-ketoglutarate.

13. A method of making a solution for peritoneal dialysis or infusion comprising:

a) providing a first solution comprising calcium ions, additional electrolytic salts and glucose in an osmotically effective concentration, the first single solution being acidified with a physiologically compatible acid to a pH of below 3.2;

b) providing a second solution comprising bicarbonate and the salt of a weak acid with a pKa<

5, the bicarbonate of the second single solution not exceeding a concentration of 10 mmol/l;

c) heat sterilizing the first solution;

d) heat sterilizing the second solution;

e) bringing the first and second solutions together to form a finished solution.