Fibrin Sealant Formulation for Room-Temperature Stability
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Solution Overview
Problem
Existing fibrin sealants require extensive thawing and warming procedures, limiting their usability and leading to waste of scarce fibrinogen material due to instability at room temperature, necessitating improved formulations for enhanced flexibility and reduced preparation steps.
Innovation Solution
Development of fibrinogen and thrombin solutions stabilized at room temperature with additives like guanidine, arginine, and cyclodextrins to maintain viscosity and activity, respectively, allowing for prolonged storage and simplified preparation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If fibrin sealant is stored frozen and requires thawing and warming before use, then stability of the product is improved, but preparation time and complexity increase significantly
Solution Approach 1:
The patent changes the storage temperature parameter from frozen (−20°C) to refrigerated (2-8°C), allowing the fibrin sealant to be stored stably without freezing while significantly reducing thawing time. This parameter change enables the product to be prepared quickly by simply removing it from refrigeration without requiring extensive warming procedures.
2Ease of operation
If fibrin sealant is stored at room temperature, then preparation time is reduced, but viscosity instability and material waste increase
Solution Approach 1:
The patent optimizes the formulation parameters including pH (adjusted to 6.5-7.5 using buffers like HEPES or TRIS), ionic strength, and additive concentrations to ensure the fibrinogen solution remains stable at refrigerated temperatures. This parameter optimization allows the product to maintain consistent viscosity during storage and after removal from refrigeration, enabling flexible usage without excessive waste.
3Reliability
If extensive thawing and warming procedures are required, then product stability is maintained, but surgical workflow efficiency decreases
Solution Approach 1:
The patent changes the storage condition from frozen to refrigerated, allowing the fibrin sealant to be quickly removed from the refrigerator and used immediately or stored at room temperature for extended periods without degradation. This eliminates the need for time-consuming thawing and warming steps, significantly improving surgical workflow efficiency while maintaining product stability through optimized formulation.
4Ease of operation
If fibrinogen is stored in liquid form at room temperature, then accessibility and ease of use improve, but degradation and waste increase
Solution Approach 1:
The patent optimizes the formulation parameters including pH buffering (pH 6.5-7.5), ionic strength, and stabilizing additives to prevent fibrinogen degradation during storage. The optimized formulation allows the liquid fibrinogen to remain stable at refrigerated temperatures for extended periods and can be removed from refrigeration and stored at room temperature for several hours without significant degradation, reducing waste while maintaining accessibility.
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 maintain dynamic viscosity and thrombin activity within specified limits, enabling flexible usage and reducing preparation time, thus enhancing usability and minimizing waste.
Implementation Method 1
Development of fibrinogen and thrombin solutions stabilized at room temperature with additives like guanidine, arginine, and cyclodextrins to maintain viscosity and activity, respectively
Implementation Method 2
Development of fibrinogen and thrombin solutions stabilized at room temperature with additives like guanidine, arginine, and cyclodextrins to maintain viscosity and activity, respectively
Implementation Method 3
Their mode of action is based on the fact that the (soluble) fibrinogen contained in a ready-to-use, liquid tissue adhesive is converted by thrombin into (insoluble) fibrin
Data Source
AI summary
Disclosed are a fibrinogen solution and a thrombin solution. The fibrinogen solution comprises fibrinogen at a concentration of at least 40 mg/ml, factor XIII, pharmaceutically acceptable additives and water. The dynamic viscosity of the fibrinogen solution measured at 20° C. increases at most by 35% after storing the solution at 20° C. for 30 days. The thrombin solution comprises thrombin, pharmaceutically acceptable additives and water.