Thromboplastin Reagent Stabilization Using Polyphenol Complexation
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current thromboplastin reagents in liquid form lack stability, requiring additional time-consuming and costly reconstitution steps and posing risks of quality impairment due to instability, which is a challenge in maintaining consistent prothrombin time measurements over storage and use.
Innovation Solution
The addition of at least one water-soluble polyphenol with a catechol function to thromboplastin reagents comprising tissue factor and phospholipids enhances stability, allowing for consistent prothrombin time measurements even after extended storage, with preferred concentrations of 0.15 to 10 mM for polyphenols like catechin or chlorogenic acid.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If thromboplastin reagents are provided in liquid form for ease of use, then ease of operation is improved, but stability of the reagent deteriorates
Solution Approach 1:
A polyphenol compound is introduced as an intermediary substance to stabilize the tissue factor in liquid thromboplastin reagents. The polyphenol forms a protective complex with tissue factor, preventing degradation while maintaining the reagent in a ready-to-use liquid state without requiring freeze-drying or reconstitution steps.
Solution Approach 2:
The chemical environment of the reagent is modified by adjusting parameters such as pH, ionic strength, and adding specific polyphenol compounds. These parameter changes create optimal conditions for tissue factor stability in liquid form, enabling long-term storage without freeze-drying while maintaining reagent activity.
2Stability of the object's composition
If freeze-drying and reconstitution steps are used to stabilize reagents, then stability is improved, but loss of time and device complexity increase
Solution Approach 1:
The unstable tissue factor component is extracted and stabilized through complexation with polyphenol compounds. This extraction and stabilization process allows the reagent to be stored in liquid form without requiring subsequent reconstitution steps, eliminating time-consuming operations while maintaining stability.
Solution Approach 2:
The tissue factor is pre-stabilized with polyphenol compounds during manufacturing, creating a ready-to-use liquid reagent. This preliminary stabilization action eliminates the need for later reconstitution steps, saving time and reducing the risk of errors associated with freeze-drying and reconstitution procedures.
3Stability of the object's composition
If freeze-drying and reconstitution steps are used to stabilize reagents, then stability is improved, but manufacturing cost increases
Solution Approach 1:
The invention replaces expensive and complex freeze-drying equipment and procedures with a simpler liquid formulation approach using polyphenol stabilizers. This substitution reduces manufacturing infrastructure requirements and operational costs while maintaining reagent stability, making the production process more economically viable.
Solution Approach 2:
By modifying the chemical parameters of the reagent formulation (adding polyphenol stabilizers, adjusting pH and ionic composition), the invention enables stable liquid storage without requiring expensive freeze-drying infrastructure. This parameter change transforms the manufacturing process from capital-intensive to operationally simpler and more cost-effective.
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 use of polyphenols stabilizes thromboplastin reagents, ensuring prothrombin time measurements remain within 25% of initial values after 12 months at 2-8°C and providing a quicker stability assessment at 37°C, indicating stability at standard storage temperatures for an extended period.
Implementation Method 1
The stability of a thromboplastin reagent may be understood to be for example the constancy of the prothrombin time for a defined plasma, e.g. a normal plasma over time.
Implementation Method 2
addition of at least one polyphenol having at least one catechol function to a thromboplastin reagent which comprises tissue factor and phospholipids
Data Source
AI summary
The present invention is in the area of coagulation analysis and relates to a reagent which is based on recombinant or native tissue factor and phospholipids and which can be stabilized by adding a polyphenol.