Aqueous peritoneal dialysis solution

• US 5,827,820 A
• Filed: 06/27/1997
• Issued: 10/27/1998
• Est. Priority Date: 04/06/1992
• Status: Expired due to Fees

• Current Assignee: Baxter International Inc.
• Original Assignee: Baxter International Inc.
• Inventors: Muller-Derlich, Jutta, duMoulin, Axel
• Primary Examiner(s): Russel, Jeffrey E.
• Application Number:
  US08/884,557
• Time in Patent Office: 487 Days
• Field of Search: 604/29, 210/646, 210/647, 435/1.1, 435/284.1, 435/297.1, 514/2, 514/21, 514/23, 514/561, 206/0.5, 206/219, 206/221, 206/524.5
• US Class Current: 514/15.4
• 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 31/195 having an amino group
• CPC Class Codes: A61K 33/10 Carbonates; Bicarbonates
• CPC Class Codes: A61K 38/02 Peptides of undefined number of amino acids; Derivatives thereof
• CPC Class Codes: A61M 1/287 Dialysates therefor

Abstract

The subject matter of this invention concerns an aqueous peritoneal dialysis solution which is obtained immediately prior to administration from two individual solutions, the first of which contains an osmotically active substance and the second of which contains bicarbonate ions, with the first individual solution containing anions of mono- and/or dicarboxylic acids and having a pH value of 4.5-5.8 and with the second individual solution containing an amino acid component or a peptide component and having a pH value of 7.2 to 10.0, and with the ready-to-use solution containing 23 to 26 mmoles/L bicarbonate ions and having a CO₂ partial pressure of 25-70 mmHg and a pH value of 7.2 to 7.6

Claims

1. A multi-part aqueous peritoneal dialysis solution comprising:

a first part comprising a first solution, the first solution comprising an osmotically active substance and carboxylic acid anions selected from the group consisting of;

monocarboxylic acid anions;

dicarboxylic acid anions; and

a mixture of monocarboxylic and dicarboxylic anions, the first solution having a pH value of 4.5 to 5.8; and

a second part comprising a second solution, the second solution comprising bicarbonate ions and a component selected from the group consisting of;

an amino acid component and a peptide component, the second solution having a pH value of 7.2 to 10;

the first part and the second part being mixed prior to administration.

2. The solution of claim 1 wherein the two parts are contained in separate chambers of a bag with two chambers.

3. The aqueous peritoneal dialysis solution of claim 1 wherein the second solution contains an amino acid component and the amino acid component is a single amino acid or a mixture of amino acids.

4. The aqueous peritoneal dialysis solution of claim 1 wherein the second solution contains a peptide component and the peptide component is a single peptide or a mixture of peptides.

5. The aqueous peritoneal dialysis solution of claim 1 wherein the osmotically active substance in the first solution is selected from the group consisting of:

glucose;

galactose;

polyglucose;

fructose;

glycerol; and

sorbitol.

6. The aqueous peritoneal dialysis solution of claim 1 wherein the carboxylic acid anion in the first solution is selected from the group consisting of:

lactate;

acetate;

citrate; and

formate.

7. The aqueous peritoneal dialysis solution of claim 1 wherein the peritoneal dialysis solution further contains ions in addition to bicarbonate ions.

8. The aqueous peritoneal dialysis solution of claim 7 wherein the ions are Na⁺, Cl^-, Ca²⁺, Mg²⁺, or K⁺.

9. A method for preparing an aqueous peritoneal dialysis solution comprising the steps of:

providing a first individual solution in a first container, the first individual solution comprising an osmotically active substance, carboxylic acid anions selected from the group consisting of;

monocarboxylic acid anions;

dicarboxylic acid anions; and

a mixture of monocarboxylic and dicarboxylic acid anions, and having a pH value of 4.5 to 5.8;

providing a second individual solution in a second container, the second individual solution comprising bicarbonate ions, a component selected from the group consisting of;

amino acid component and peptide component, and having a pH value of 7.2 to 10;

mixing the first individual solution with the second individual solution immediately prior to patient administration in a final container, the dialysis solution containing 23 to 26 mmol/L bicarbonate ions, having a CO₂ partial pressure of 27-70 mmHg, and having a pH value of 7.2 to 7.6.

10. The method of claim 9 wherein the second individual solution contains an amino acid component, the amino acid component selected from the group consisting of:

a single amino acid; and

a mixture of amino acids.

11. The method of claim 9 wherein the osmotically active substance in the first individual solution is selected from the group consisting of:

glucose;

galactose;

polyglucose;

fructose;

glycerol; and

sorbitol.

12. The method of claim 9 wherein the carboxylic acid anion is selected from the group consisting of:

lactate;

acetate;

citrate; and

formate.

13. The method of claim 9 further including the step of adding ions selected from the group consisting of:

Na⁺, Cl^-, Ca²⁺, Mg²⁺, and K⁺ to the dialysis solution.

14. The method of claim 9 further comprising mixing the first individual solution with the second individual solution in a ratio of 3:

1 to 1;

3 by volume.

15. The method of claim 9 wherein the carboxylic acid anions are present in the peritoneal dialysis solution in a concentration of 5 to 100 mmol/L.

16. The method of claim 9 wherein the amino acid component or the peptide component is present in the peritoneal dialysis solution in a concentration of 0.05 wt % to 2 wt %.

17. An apparatus for performing peritoneal dialysis comprising:

a first chamber containing a first solution, the first solution comprising an osmotically active substance and carboxylic anions selected from the group consisting of;

monocarboxylic acids;

dicarboxylic acids; and

mixtures of monocarboxylic and dicarboxylic acids, and having a pH value of 4.5 to 5.8;

a second chamber containing a second solution, the second solution comprising bicarbonate ions and a component selected from the group consisting of;

an amino acid component and a peptide component, and having a pH value of 7.2 to 10;

means for combining the first solution and the second solution to form an aqueous peritoneal dialysis solution, the aqueous peritoneal dialysis solution comprising 23 to 26 mmol/L bicarbonate ions, has a CO₂ partial pressure of 27-70 mmHg and has a pH value of 7.2 to 7.6.

18. The apparatus of claim 17 wherein the means for combining is a valve between the first chamber and the second chamber which can be opened to mix the first and second solutions together.

19. The apparatus of claim 17 wherein the component in the second chamber is the peptide component.

20. A method for preparing an aqueous peritoneal dialysis solution comprising the steps of:

providing a first individual solution in a first container, the first individual solution comprising an osmotically active substance, carboxylic acid anions selected from the group consisting of;

monocarboxylic acid anions;

dicarboxylic acid anions; and

a mixture of monocarboxylic and dicarboxylic acid anions; and

having a pH value of 4.5 to 5.8;

providing a second individual solution in a second container, the second individual solution comprising bicarbonate ions and a peptide component selected from the group consisting of;

a single peptide; and

a mixture of peptides; and

having a pH value of 7.2 to 10;

mixing the first individual solution with the second individual solution immediately prior to patient administration in a final container to form the aqueous peritoneal dialysis solution, the aqueous peritoneal dialysis solution containing 23 to 26 mmol/L bicarbonate ions, having a CO₂ partial pressure of 27-70 mmHg, and having a pH value of 7.2 to 7.6.