Pyrophosphate Dialysis Solutions Stabilized by Bicarbonate Buffer

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Solution Overview

Problem

Patients undergoing dialysis therapies often suffer from pyrophosphate deficiencies, leading to vascular calcification, which existing dialysis solutions fail to adequately address due to instability of pyrophosphate during sterilization and storage.

Innovation Solution

Development of stable dialysis solutions containing a therapeutically effective amount of pyrophosphate, heat sterilized using techniques like autoclave or steam, with specific formulations that include bicarbonate buffers to maintain pH above 6, ensuring pyrophosphate stability during sterilization and storage, and provided in single or multi-part containers for easy administration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If pyrophosphate is added to dialysis solutions to prevent vascular calcification, then therapeutic efficacy is improved, but pyrophosphate stability deteriorates during sterilization and storage

Engineering Contradiction:
Improvetherapeutic efficacyVSAvoidpyrophosphate stability
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The patent introduces bicarbonate buffer as an intermediary substance that mediates between pyrophosphate and the sterilization/storage environment. The bicarbonate buffer system maintains pH above 6, which creates a protective chemical environment that prevents pyrophosphate degradation while allowing the pyrophosphate to perform its therapeutic function of preventing vascular calcification.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent changes the pH parameter of the dialysis solution by using bicarbonate buffer to maintain pH above 6. This parameter change fundamentally alters the stability characteristics of pyrophosphate, transforming it from an unstable compound that degrades during sterilization to a stable compound that remains therapeutically effective throughout storage and administration.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If heat sterilization is applied to dialysis solutions to ensure sterility, then reliability is improved, but pyrophosphate stability deteriorates

Engineering Contradiction:
ImprovesterilityVSAvoidpyrophosphate stability
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The patent applies preliminary action by establishing the bicarbonate buffer system and adjusting pH above 6 before the heat sterilization process. This preliminary chemical preparation creates a protective environment that prevents pyrophosphate degradation during the subsequent sterilization, allowing the solution to achieve both sterility and pyrophosphate stability.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent changes the pH parameter to above 6 using bicarbonate buffer before sterilization. This parameter change transforms the chemical environment from one that causes pyrophosphate degradation during heat exposure to one that protects pyrophosphate stability, enabling successful heat sterilization without compromising the therapeutic agent.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If pyrophosphate is included in dialysis solutions to address vascular calcification, then therapeutic benefit is improved, but storage stability deteriorates

Engineering Contradiction:
Improvetherapeutic benefitVSAvoidstorage stability
Core Design Contradiction:
ReliabilityVSDuration of action of stationary object

Solution Approach 1:

The patent changes the pH parameter to above 6 and maintains it throughout storage using bicarbonate buffer. This parameter change extends the duration of action by preventing pyrophosphate degradation over time, allowing the solution to remain stable during extended storage periods while maintaining therapeutic efficacy for preventing vascular calcification.

Inventive Principle:
Principle #35Parameter changes

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 solutions effectively maintain a stable and therapeutically effective amount of pyrophosphate, reducing vascular calcification risks and providing improved dialysis treatments by ensuring pyrophosphate stability during sterilization and storage, thus enhancing patient care.

Implementation Method 1

The dialysis solution can have a pH of above 6 to reduce the degradation of the pyrophosphate

Methodology Applied
Scientific EffectBuffering:

Implementation Method 2

The dialysis solution is heat sterilized, for example, using a technique such as autoclave, steam or a combination thereof

Methodology Applied
Scientific EffectHeat sterilization: Heating

Data Source

PatentEP2211874B1Sterilised dialysis solutions containing pyrophosphate
Publication Date: 2013.12.11 BAXTER INT INC

AI summary

Dialysis solutions comprising pyrophosphates and methods of making and using the dialysis solutions are provided. In an embodiment, the present disclosure provides a dialysis solution comprising a stable and therapeutically effective amount of pyrophosphate. The dialysis solution can be sterilized, for example, using a technique such as autoclave, steam, high pressure, ultra-violet, filtration or combination thereof. The dialysis solution can be in the form of a concentrate.