Ready-to-use Tranexamic Acid IV Solution Stability
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Solution Overview
Problem
Tranexamic acid solutions for injection require dilution before use, leading to stability issues, potential contamination, and dosage errors, and are only stable for short periods, making them inconvenient and unsafe for medical use.
Innovation Solution
Development of ready-to-use, stable pharmaceutical compositions of tranexamic acid with specific pH and tonicity agents, eliminating the need for dilution and improving stability and safety.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If tranexamic acid solution is diluted before use, then it can be administered to patients, but it becomes unstable after 24 hours at 2-8°C or 4 hours at room temperature
Solution Approach 1:
The patent changes the pH parameter of the tranexamic acid solution to a specific range (pH 3.5-6.5) to achieve both immediate readiness for use and long-term stability. This parameter modification allows the solution to remain stable for at least one year at room temperature without dilution, resolving the contradiction between ease of operation and stability.
2Ease of operation
If tranexamic acid solution is diluted, then it can be prepared for administration, but there is potential for contamination and dosage errors
Solution Approach 1:
The patent performs preliminary action by formulating the tranexamic acid solution with appropriate pH adjustment and tonicity agents during manufacturing, making it ready for immediate administration without requiring dilution. This eliminates the dilution step that could introduce contamination or dosage errors, thereby improving reliability while maintaining ease of operation.
3Duration of action of stationary object
If concentrated tranexamic acid solution is stored, then it can be used later, but it is only stable for short periods requiring refrigeration
Solution Approach 1:
The patent modifies the chemical parameters of the solution by adjusting pH to 3.5-6.5 and adding specific tonicity agents, which extends the storage duration to at least one year at room temperature. This eliminates the need for refrigeration and significantly increases the duration for which the solution remains stable without active cooling.
4Adaptability or versatility
If tranexamic acid is administered in diluted form, then dosage can be adjusted, but dosage errors may occur
Solution Approach 1:
The patent performs preliminary action by preparing the solution with precise pH adjustment and known concentrations during manufacturing. The solution is provided in predetermined volumes with accurate dosing, eliminating the need for healthcare providers to perform dilution calculations that could lead to dosage errors, while maintaining the ability to administer appropriate doses.
Data Source
AI summary
Ready-to-use, stable aqueous intravenous tranexamic acid compositions are provided.