Sterilizing Polysaccharide Solutions via Beta-Lactone
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Solution Overview
Problem
Current sterilization methods for aqueous polysaccharide solutions, such as gamma radiation and chemical agents, lead to polymer degradation, inhomogeneous viscosity, and residual toxicity, making it difficult to achieve sterile solutions suitable for visco-supplementation without significant side effects.
Innovation Solution
The method involves adding β-lactone to an aqueous polysaccharide solution with a buffer, storing it at 4° C to 40° C for at least 24 hours, which effectively inactivates microorganisms without significant polymer degradation or viscosity changes, maintaining the solution's pH and rheological properties.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If gamma radiation sterilization is used, then sterilization effectiveness is improved, but polymer degradation and viscosity inhomogeneity increase
Solution Approach 1:
The patent changes the sterilization parameter from high-energy gamma radiation to chemical sterilization using peracetic acid at controlled concentrations (0.01-5% w/v) and temperatures (20-80°C), which achieves sterilization without the polymer degradation caused by ionizing radiation
Solution Approach 2:
The patent introduces peracetic acid as an intermediary sterilizing agent that acts on microorganisms without directly attacking polymer chains, unlike gamma radiation which causes direct bond breaking in polysaccharides
2Reliability
If oxidizing agents are used for sterilization, then sterilization effectiveness is improved, but oxidative degradation of hyaluronic acid increases
Solution Approach 1:
The patent optimizes the oxidation potential by using peracetic acid at controlled low concentrations (0.01-5% w/v) and controlled temperatures (20-80°C), achieving sterilization while minimizing oxidative degradation through precise parameter control
Solution Approach 2:
The patent uses a partial oxidation approach with peracetic acid, applying just enough oxidizing power to kill microorganisms (sterilization) without excessive oxidation that would degrade the hyaluronic acid polymer chains
3Reliability
If sterile filtration is used, then removal of microbial life forms is improved, but virus inactivation fails and processing difficulty increases due to high viscosity
Solution Approach 1:
The patent replaces the mechanical filtration method with chemical sterilization using peracetic acid, which can inactivate viruses through chemical action on viral structures, unlike physical filtration that only removes particles based on size
4Reliability
If formaldehyde or glutardialdehyde sterilization is used, then sterilization effectiveness is improved, but residual toxicity increases requiring removal steps
Solution Approach 1:
The patent changes from aldehyde-based sterilization to peracetic acid sterilization, where the byproducts (acetic acid and water) are non-toxic and do not require removal, eliminating the residual toxicity problem associated with aldehyde sterilization
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 ensures minimal polymer degradation and maintains the viscosity and pH of the polysaccharide solutions, providing sterile products suitable for visco-supplementation with no discolouration or residual toxicity, thus ensuring effective sterilization without the drawbacks of existing methods.
Implementation Method 1
a β-lactone is added to an aqueous solution of a polysaccharide in the presence of a buffer, and the mixture is stored at a temperature of 4° C. to 40° C. for a period of at least 24 hours
Implementation Method 2
the aqueous solution contains a buffer system whose buffering capacity is sufficient to buffer the 3-hydroxypropanoic acid generated by hydrolysis of the β-lactone such that the pH value of the sterilized aqueous polysaccharide solution is equal to that of the unsterilized polysaccharide solution
Implementation Method 3
buffer the 3-hydroxypropanoic acid generated by hydrolysis of the β-lactone
Data Source
AI summary
Sterilization method according to which an aqueous polysaccharide solution is stored in the presence of a lactone and a buffer system for a period of at least 24 hours, and a sterile polysaccharide solution produced in this way.