Acidic Haemostatic Composition With PVA for Stable Viscosity
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Solution Overview
Problem
Existing haemostatic compositions are not effective for diverse tissue applications, have suboptimal viscosity for handling, and lack long-term stability, particularly when combining metal chlorides with polyvinyl alcohol (PVA) due to incompatibility issues.
Innovation Solution
A haemostatic composition comprising ferric chloride, aluminium chloride, polyvinyl alcohol, ethanol, and water, formulated to be highly acidic with a pH of 1-3, providing stability and enhanced efficacy despite acidic conditions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If metal chlorides (ferric chloride, aluminium chloride) are combined with polyvinyl alcohol to improve viscosity and handling, then the composition becomes unstable due to incompatibility between metal salts and PVA
Solution Approach 1:
The patent introduces ethanol as an intermediary solvent that mediates between the metal chlorides and polyvinyl alcohol. The ethanol-water mixture serves as a compatible medium that allows PVA to dissolve and provide viscosity enhancement without causing precipitation or instability that would occur with direct combination of metal salts and PVA in aqueous solutions alone.
Solution Approach 2:
The patent changes the solvent system parameters by using a specific ethanol-water mixture ratio and controlling the pH at highly acidic levels (pH 1-3). These parameter changes create optimal conditions where PVA remains stable and provides desired viscosity while being compatible with the metal chloride haemostatic agents.
2Reliability
If highly acidic environment (pH 1-3) is created to enhance haemostatic effect of metal chlorides, then stability of the composition deteriorates
Solution Approach 1:
The patent creates a composite formulation combining metal chlorides, polyvinyl alcohol, ethanol, and water in specific proportions. This composite material structure allows the highly acidic environment to maintain haemostatic efficacy while the overall composition remains stable due to the synergistic interactions between components, particularly the ethanol-PVA-metal chloride compatibility.
Solution Approach 2:
Ethanol acts as a stabilizing intermediary that allows the composition to tolerate highly acidic conditions. The ethanol molecules help stabilize the metal chloride complexes and maintain PVA solubility even at pH 1-3, preventing decomposition or precipitation that would otherwise occur in such extreme acidity.
3Reliability
If conventional haemostatic compositions are used, then they provide basic haemostatic effect, but they lack improved viscosity for easy application and long-term stability
Solution Approach 1:
The patent merges multiple conventional haemostatic agents (ferric chloride and aluminium chloride) with a viscosity-providing polymer (polyvinyl alcohol) in a unified formulation. This combination allows the composition to simultaneously deliver enhanced haemostatic effect from the metal chlorides and improved application properties from the PVA-based viscosity, creating a single product that addresses both efficacy and ease of use.
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 composition achieves stable, effective haemostasis with improved viscosity for easy application, maintaining stability over time and promoting wound healing without epithelial damage.
Implementation Method 1
The haemostatic effect in this case may be related to its hydrolysis to HCl
Implementation Method 2
Haemostasis is thought to result from denaturation and agglutination of proteins (such as fibrinogen) by ferric ions, boosted by the low pH and the subsulphate group
Implementation Method 3
Haemostasis is thought to result from denaturation and agglutination of proteins (such as fibrinogen) by ferric ions
Implementation Method 4
polyvinyl alcohol in an amount comprised in the range 5-15 wt% and the pharmaceutically acceptable excipients ethanol in an amount comprised in the range 10-25 wt% and water, wherein the composition has a pH comprised between 1 and 3
Data Source
Figure 1A~1B
AI summary
The present invention relates to a haemostatic composition comprising the combination of ferric chloride or a hydrate thereof and aluminium chloride or a hydrate thereof as haemostatic active agents, polyvinyl alcohol as viscosifying agent and a mixture of ethanol and water as solvent. The invention also relates to the use of this composition for promoting haemostasis, for example, after minor surgical procedures.