Icodextrin Dialysis Fluid Segmentation for Stability
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Solution Overview
Problem
Current peritoneal dialysis fluids using icodextrin face challenges in maintaining stability during heat sterilization and storage, with pH levels affecting icodextrin decomposition and coloring, leading to reduced product value and increased risk of peritonitis.
Innovation Solution
A sterile peritoneal dialysis fluid is developed with a two-component system, where an acidic first liquid containing icodextrin and sodium chloride is mixed with an alkaline second liquid containing a pH regulator, allowing for aseptic mixing before use, with specific pH ranges to prevent decomposition and maintain physiological compatibility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the pH of peritoneal dialysis fluid is increased to physiological range (6.5-7.5), then safety and immunological defense are improved, but icodextrin decomposition and coloring increase
Solution Approach 1:
The peritoneal dialysis fluid is divided into two separate components: an acidic first liquid containing icodextrin (pH 5.0-5.5) and an alkaline second liquid containing pH regulators (pH 6.5-7.5). These components are stored separately to prevent icodextrin decomposition, then mixed aseptically immediately before use to achieve the desired physiological pH range while maintaining icodextrin stability during storage and heat sterilization.
2Stability of the object's composition
If icodextrin is stored at acidic pH (5.0-5.5), then icodextrin stability is maintained, but immunological defense mechanism is lowered and peritonitis risk increases
Solution Approach 1:
The two-component system is prepared in advance with the first liquid containing icodextrin at acidic pH for stability, and the second liquid containing alkaline pH regulators prepared separately. Both components are sterilized and stored ready for use, then mixed aseptically immediately before administration to achieve physiological pH that restores immunological defense while preventing premature icodextrin decomposition.
3Reliability
If a single-component peritoneal dialysis fluid with physiological pH is used, then safety is improved, but icodextrin decomposition and coloring occur during manufacture and storage
Solution Approach 1:
The fluid is segmented into two separate sterilizable components: the first liquid containing icodextrin at acidic pH that remains stable during manufacture and storage, and the second liquid containing alkaline pH regulators. This segmentation allows each component to be manufactured and stored independently under optimal conditions, then combined aseptically before use to achieve physiological pH without compromising icodextrin stability during the manufacturing process.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The solution effectively suppresses icodextrin decomposition and coloring, maintaining stability and safety by adjusting pH to physiological ranges, reducing glucose decomposition products and enhancing the fluid's osmotic pressure for effective dialysis.
Implementation Method 1
Icodextrin is not rapidly absorbed via the peritoneum due to a large molecular weight, and acts mainly as a colloid osmotic agent, and a dehydration effect can be obtained while maintaining the osmotic pressure with blood plasma.
Implementation Method 2
an alkaline second liquid containing an alkaline pH regulator, in which the first liquid after sterilization has a pH of 5.0 to 5.5, the second liquid after sterilization has a pH of 6.5 to 7.5, and a mixture of the first liquid and the second liquid after sterilization has a pH of 6.0 to 7.5
Data Source
AI summary
The present invention is a sterile peritoneal dialysis fluid, including an acidic first liquid containing 60.0 to 94.0 g/L of icodextrin and 0 to 2.34 g/L of sodium chloride, and an alkaline second liquid containing an alkaline pH regulator, in which the first liquid after sterilization has a pH of 5.0 to 5.5, the second liquid after sterilization has a pH of 6.5 to 7.5, and a mixture of the first liquid and the second liquid after sterilization has a pH of 6.0 to 7.5. The present invention can provide a peritoneal dialysis fluid containing icodextrin, in which the stability of icodextrin during the heat sterilization and the subsequent storage can be improved to the maximum, and the pH of the peritoneal dialysis fluid is close to the physiological range.