Stable Liquid Thrombin via High Glycerol Concentration
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Solution Overview
Problem
Existing liquid thrombin compositions are unstable due to thrombin's autocatalytic function, requiring storage as powders or frozen liquids, which complicates handling and sterility.
Innovation Solution
A stable liquid thrombin composition is achieved by incorporating more than 50% v/v glycerol, which enhances thrombin stability and activity, allowing for sterilization by filtration at elevated temperatures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If thrombin is stored as liquid without stabilizing agents, then it maintains high activity, but it becomes unstable due to autocatalytic function
Solution Approach 1:
Glycerol acts as an intermediary substance that mediates between the conflicting requirements of maintaining thrombin activity and preventing autocatalytic degradation. The high concentration of glycerol creates a protective environment that stabilizes thrombin without requiring additional stabilizing agents that would reduce activity.
Solution Approach 2:
The invention changes the physical-chemical parameters of the liquid composition by using more than 50% v/v glycerol as the primary component. This parameter change fundamentally alters the stability characteristics of thrombin, allowing it to remain stable in liquid form without additional stabilizers.
2Stability of the object's composition
If stabilizing agents are added to liquid thrombin, then storage stability improves, but thrombin activity is reduced due to inhibition
Solution Approach 1:
Glycerol serves as a unique intermediary that provides stabilization without the inhibitory effects associated with traditional stabilizing agents. It creates a protective microenvironment for thrombin while maintaining full enzymatic activity, unlike conventional stabilizers that would compromise function.
Solution Approach 2:
By changing the compositional parameters to use more than 50% v/v glycerol, the invention achieves a state where stabilization and activity are compatible. This parameter change eliminates the need for separate stabilizing agents that would otherwise inhibit thrombin function.
3Stability of the object's composition
If thrombin is provided as powder or frozen liquid, then stability is maintained, but handling complexity and sterility issues increase
Solution Approach 1:
The invention changes the storage parameters by using high concentration glycerol (>50% v/v) as the liquid medium, which allows thrombin to remain stable in liquid form at various temperatures. This eliminates the need for freezing or powder form, greatly simplifying handling while maintaining sterility through filtration capability.
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 high glycerol concentration maintains thrombin activity at elevated temperatures, facilitating sterile production, improved handling, and enhanced hemostatic efficacy.
Implementation Method 1
The high glycerol concentration maintains thrombin activity at elevated temperatures
Implementation Method 2
allowing for sterilization by filtration at elevated temperatures
Data Source
AI summary
The present invention provides methods for large scale preparation of sterile stable liquid thrombin composition comprised of glycerol; stable liquid thrombin compositions; and hemostatic composition and kits. The present invention further provides hemostatic compositions comprised of liquid thrombin, glycerol and gelatin. Further provided herein is a method for the large-scale production of a sterile liquid thrombin composition comprised of glycerol.