Lyophilized Hemostatic Composition Merging Thrombin and Polymer
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Solution Overview
Problem
Existing hemostatic compositions require separate reconstitution and mixing of thrombin and biocompatible polymer components, which can lead to stability issues and increased handling complexity, especially in intensive care settings, due to differing sterilization requirements and potential enzymatic activity loss during harsh sterilization methods.
Innovation Solution
A process involving a dry preparation of a coagulation-inducing agent and a biocompatible polymer, mixed under controlled conditions to form a wet paste, followed by freezing and lyophilization, resulting in a stable, combined dry composition that can be easily reconstituted with a pharmaceutically acceptable diluent for medical use.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If thrombin and biocompatible polymer are manufactured and provided separately to maintain their stability, then storage stability is improved, but device complexity and handling steps increase
Solution Approach 1:
The patent combines separately manufactured thrombin and biocompatible polymer components into a single final container after lyophilization. The thrombin-containing solution is mixed with the granular matrix material, frozen, and lyophilized together to create a unified dry hemostatic composition that maintains the stability benefits of separate manufacturing while eliminating the need for separate handling and mixing steps at the point of use.
2Reliability
If powerful sterilization methods are used for the matrix material, then sterilization effectiveness is improved, but enzymatic activity of thrombin is lost
Solution Approach 1:
The patent applies different sterilization methods to different components at different stages. The biocompatible polymer matrix material undergoes powerful sterilization methods (autoclaving, gamma-irradiation) during manufacturing. The thrombin component is sterilized by filtration or other gentle methods that preserve enzymatic activity. The components are then combined and lyophilized together, ensuring both sterilization effectiveness and preservation of thrombin activity.
3Object-generated harmful factors
If thrombin is treated with gentle handling to preserve enzymatic activity, then enzymatic activity is maintained, but sterilization effectiveness decreases
Solution Approach 1:
The patent segments the sterilization process by applying gentle sterilization methods (filtration, low-temperature processing) specifically to the thrombin component to preserve enzymatic activity, while applying powerful sterilization methods to the biocompatible polymer matrix material separately. The two sterilized components are then combined through lyophilization to achieve overall sterilization effectiveness without compromising thrombin activity.
4Stability of the object's composition
If separate reconstitution and mixing steps are required, then component stability is maintained, but time consumption and handling complexity increase
Solution Approach 1:
The patent merges the reconstitution process by combining the thrombin-containing solution with the granular matrix material in a single mixing step after lyophilization. Both components are already in their final container, so adding the diluent and mixing creates a ready-to-use hemostatic composition without requiring separate reconstitution and mixing steps, reducing time consumption while maintaining component stability through the lyophilization 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
This method provides a convenient, storage-stable hemostatic composition with reduced handling steps and minimized enzymatic activity loss, allowing for efficient delivery of a ready-to-use product with enhanced storage stability and ease of administration.
Implementation Method 1
freezing and lyophilizing said paste in said container
Implementation Method 2
freezing and lyophilizing said paste in said container thereby obtaining a dry and stable hemostatic composition
Data Source
AI summary
Described is a process for making a dry and stable hemostatic composition, said process comprisinga) providing a first component comprising a dry preparation of a coagulation inducing agent,b) providing a second component comprising a dry preparation of a biocompatible polymer suitable for use in hemostasis,c) mixing said first component and said second component under conditions effective to form a wet paste while essentially preventing degradation of the second component by said first component in a final container or transferring said wet paste into a final container,d) freezing and lyophilizing said paste in said container thereby obtaining a dry and stable hemostatic composition comprising said first and said second component in lyophilized form, ande) finishing said dry and stable hemostatic composition in said final container to a storable pharmaceutical device containing said first component and said second component in a combined form as a dry and stable hemostatic composition.