Sterilizing S-nitrosothiols via Ionizing Radiation
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Solution Overview
Problem
S-nitrosothiols, such as S-nitrosoglutathione, are highly unstable and sensitive to air, temperature, moisture, and electromagnetic radiation, making it challenging to maintain their purity and stability for pharmaceutical use, particularly in sterile parenteral forms, which is essential for safe and effective administration.
Innovation Solution
Exposing dry solid S-nitrosothiol or pharmaceutical pre-compositions to a sterilizing dose of ionizing radiation in a sealed environment minimizes degradation, allowing for the production of sterile S-nitrosothiols with maintained purity, suitable for clinical use, and enabling the creation of stable, ready-to-use pharmaceutical compositions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If S-nitrosothiols are stored under controlled air, radiation and temperature conditions, then stability is improved, but storage duration is limited to only 6-9 months
Solution Approach 1:
The patent applies inert atmosphere by storing S-nitrosothiols in sealed containers filled with inert gas (nitrogen or argon) to exclude oxygen and moisture. This creates a protective environment that prevents oxidative degradation and hydrolysis, extending storage duration from 6-9 months to at least 12 months while maintaining stability.
2Reliability
If S-nitrosothiols are sterilized by conventional methods, then sterility is achieved, but purity is significantly reduced due to degradation
Solution Approach 1:
The patent employs sterile filtration through 0.22 μm pore size filters as a disposable sterilization method. The filter physically removes microorganisms without exposing the S-nitrosothiol to degrading conditions (heat, radiation, chemicals), thereby achieving sterility while maintaining high purity and minimal degradation.
3Ease of operation
If S-nitrosothiols are formulated as liquid solutions, then ease of administration is improved, but stability deteriorates with quantitative decomposition within hours
Solution Approach 1:
The patent changes the physical state parameter from liquid solution to solid powder form. This phase transition dramatically improves stability, allowing the S-nitrosothiol to be stored as a stable solid that can be reconstituted into liquid form immediately before administration, thus resolving the contradiction between ease of administration and stability.
4Stability of the object's composition
If S-nitrosothiols are stored as solid particles, then stability is improved compared to liquid, but decomposition still occurs rapidly under physiological conditions
Solution Approach 1:
The patent segments the S-nitrosothiol into individual solid particles or powders that can be rapidly dissolved in sterile liquid media immediately before administration. This segmentation allows the stable solid form to be maintained during storage while enabling quick conversion to liquid form for extended duration of action during administration.
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 effectively sterilizes S-nitrosothiols without significant purity loss, ensuring the stability and efficacy of the active agent, overcoming the limitations of existing methods that fail to maintain purity and sterility, thus facilitating their use in pharmaceutical applications.
Implementation Method 1
exposing dry solid S-nitrosothiol or pharmaceutical pre-compositions to a sterilizing dose of ionizing radiation
Data Source
AI summary
This invention provides a method of sterilizing an S-nitrosothiol, for example S-nitrosoglutathione, without reduction of purity by more than about 5.0% through degradation. The invention allows sterile S-nitrosothiol or a sterile pharmaceutical pre-composition comprising S-nitrosothiol, wherein the S-nitrosothiol is in dry solid form, to be produced. The sterile pharmaceutical pre-composition is mixed with one or more diluents, excipients, carriers, additional active agents, or any combination thereof, for example sterile saline, to prepare a pharmaceutical composition of S-nitrosothiol for use.