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Bicarbonate-based solution in two parts for peritoneal dialysis or substitution in continuous renal replacement therapy

A technology of bicarbonate and sodium bicarbonate is applied in peritoneal dialysis, devices that make medicines into special physical or oral forms, dialysis systems, etc. and other issues, to achieve the effect of low cost

Inactive Publication Date: 2002-02-20
BAXTER INT INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0017] The problem with both approaches is that bicarbonate based solutions require a gas barrier to act as the base container or outer cover
Of course, preparing bicarbonate solutions in hospitals is time consuming and creates problems with sterility
On the other hand, steam sterilizable gas barrier materials are more expensive and may lose their barrier properties unexpectedly due to damage during production and / or shipping

Method used

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  • Bicarbonate-based solution in two parts for peritoneal dialysis or substitution in continuous renal replacement therapy
  • Bicarbonate-based solution in two parts for peritoneal dialysis or substitution in continuous renal replacement therapy
  • Bicarbonate-based solution in two parts for peritoneal dialysis or substitution in continuous renal replacement therapy

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0083] Example 1. Preparation of a bicarbonate-based concentrate with a pH of 8.6. Further pH adjustments can be made during storage. However, an initial adjustment ensures that the pH is within the physiological range (6.5-7.6) after mixing.

[0084] The container is a two-compartment bag with each compartment separated by a sealing skin. The pH of the bicarbonate-containing solution and the dextrose-containing solution should be matched to ensure that after mixing (1:1 volume ratio mixing) the pH is within the physiological range. The compositions and pH adjustments of the sterile dextrose and bicarbonate concentrates are listed in Tables 8 and 9, respectively.

[0085] composition

Glucose.H 2 O g / l

85.00

CaCl 2 .2H 2 O g / l

0.368

MgCl 2 .6H 2 O g / l

0.102

pH at ambient conditions

2.0 *

[0086] composition

10.76

3.36

4.20

8.6

Sodi...

Embodiment 2

[0092] Example 2. The pH of the bicarbonate concentrate was adjusted to about 9.5 by adding sodium hydroxide. After mixing with acidified glucose solution, the pH of the resulting mixture remained in the physiological range throughout the 6-month study.

[0093] The container is a two-compartment bag with the compartments separated by a seal. The pH of the bicarbonate-containing solution and the dextrose-containing solution should be matched to ensure that the pH is within the physiological range after mixing (1:1 volume ratio). The compositions and pH adjustments of the tested sterile dextrose and bicarbonate concentrates are listed in Tables 11 and 12, respectively.

[0094] composition

[0095] composition

[0096] * : Adjust the pH of the solution with NaOH

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Abstract

The present invention provides devices and methods for stabilizing bicarbonate-based solutions for peritoneal dialysis or hemofiltration. The bicarbonate-based solutions of the present invention are formulated and stored in at least two parts - an alkaline bicarbonate concentrate and an acidic concentrate. The alkaline bicarbonate concentrate is adjusted to have a pH of about 8.6 to 10.0. The acidic concentrate is adjusted to have a stable, acidic pH ranging from about 1.0 to 3.0. Upon mixing, although some variation in the pH of the mixed bicarbonate solution exists, the inventors have discovered that with the appropriate selection of the parameters of the concentrates, the pH of the mixed solution is always within an acceptable physiological range.

Description

Background of the invention [0001] The present invention relates to peritoneal dialysis or renal replacement therapy, such as hemofiltration and hemodiafiltration. In particular, the invention relates to the preparation and storage of bicarbonate-based solutions for peritoneal dialysis and hemofiltration. [0002] To overcome the shortcomings of traditional hemodialysis, other techniques such as peritoneal dialysis and hemofiltration have been developed. Peritoneal dialysis uses the patient's own peritoneum as a semipermeable membrane. As the inner membrane of the body cavity, the peritoneum can be used as a natural semi-permeable membrane due to the richness of a large number of blood vessels and capillaries. [0003] During peritoneal dialysis, a catheter is used to introduce sterile dialysate into the peritoneal cavity. Solute exchange between dialysate and blood is achieved over a sufficiently long time. Fluid flow is achieved by forming an appropriate osmotic gradient...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61J3/00A61J1/05A61J1/10A61J1/20A61K33/10A61K33/14A61M1/14A61M1/16A61M1/28A61P13/12
CPCA61M1/1654A61K33/14A61M1/287A61K33/10A61K2300/00
Inventor 安尼克·杜蓬谢尔德克·费克特帕特里克·巴尔蒂让-皮埃尔·哈特曼利奥·马尔蒂斯弗朗切斯科·佩卢索
Owner BAXTER INT INC
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