Thrombocyte Stabilization Formulations at Ambient Temperatures

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Solution Overview

Problem

Existing methods fail to maintain the stability and functionality of thrombocytes at ambient temperatures for extended periods, making accurate analysis and storage challenging for research, diagnostic, and therapeutic purposes.

Innovation Solution

Formulations comprising a pH buffer, an anticoagulant, a non-reducing sugar, a polyol, and a functionalized carbohydrate are used to stabilize thrombocytes in an inactivated state at ambient temperatures for at least 24 hours, ensuring their functionality and ability to be activated post-collection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If anti-coagulants are added to maintain thrombocytes in an inactivated state at ambient temperatures, then thrombocyte aggregation is prevented, but thrombocyte stability and functionality are lost after 24 hours

Engineering Contradiction:
Improvethrombocyte stabilityVSAvoidstorage duration
Core Design Contradiction:
Stability of the object's compositionVSDuration of action of stationary object

Solution Approach 1:

The invention changes the chemical parameters of the storage medium by incorporating specific concentrations of glucose (5.5-27.7 mM), fructose (5.5-27.7 mM), and EDTA (0.02-0.2 mM) to create optimal conditions for thrombocyte stabilization. This parameter optimization allows thrombocytes to remain stable and functional at ambient temperatures for extended periods up to 7 days

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The invention uses a composite formulation combining multiple substances (glucose, fructose, EDTA, and other components) working together to achieve thrombocyte stabilization. This composite approach addresses the limitations of single anti-coagulants by providing both aggregation prevention and long-term stability through synergistic interactions among the components

Inventive Principle:
Principle #40Composite materials

2Ease of operation

If thrombocytes are stored at ambient temperatures, then storage and shipping logistics are simplified, but thrombocyte activation and aggregation occur rapidly

Engineering Contradiction:
Improvestorage convenienceVSAvoidthrombocyte inactivation
Core Design Contradiction:
Ease of operationVSStability of the object's composition

Solution Approach 1:

The invention introduces EDTA as an intermediary substance that mediates between the thrombocytes and the ambient environment. EDTA chelates calcium ions, preventing calcium-dependent activation pathways while allowing the thrombocytes to remain in an inactivated state during ambient temperature storage and shipping

Inventive Principle:
Principle #24Intermediary (Mediator)

3Duration of action of stationary object

If thrombocytes are maintained in an inactivated state for extended periods, then storage time is increased, but post-collection activation capability is reduced

Engineering Contradiction:
Improvestorage timeVSAvoidactivation capability
Core Design Contradiction:
Duration of action of stationary objectVSReliability

Solution Approach 1:

The invention provides beforehand cushioning by incorporating protective agents (glucose, fructose, EDTA) in the storage formulation that prevent irreversible damage to thrombocytes during extended storage. These agents cushion against metabolic stress and maintain membrane integrity, ensuring that thrombocytes retain their activation capability even after 7 days of ambient temperature storage

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

Data Source

PatentUS20250160319A1Stabilization of thrombocytes at ambient temperatures
Publication Date: 2025.05.22 BIOMATRICA INC

AI summary

Provided herein are formulations and methods for the stabilization of one or more thrombocytes at ambient temperatures. Also provided are formulations and methods for the stabilization of one or more thrombocytes in an inactivated state in a blood sample at ambient temperatures. Further provided are articles of manufacture and kits and methods for substantially stable storage of one or more thrombocyte at ambient temperatures.