Ready-to-Use Phenylephrine Solution with Oxygen-Absorbing Packaging
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Solution Overview
Problem
Existing phenylephrine formulations face issues with physical and chemical degradation, require terminal sterilization, and contain antioxidants like sodium metabisulfite or chelating agents, leading to stability concerns and potential contamination risks, especially in ready-to-use solutions for treating hypotension.
Innovation Solution
A ready-to-use, sterile phenylephrine solution packaged with an oxygen absorber, free of sodium metabisulfite and EDTA, is developed in an infusion container, ensuring stability for 24 months at room temperature without terminal sterilization, using a multilayer polyolefin film and a twist-off closure system.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If phenylephrine formulations are made ready-to-use and sterile without terminal sterilization, then sterility and dosing accuracy are maintained, but the formulation requires advanced packaging with oxygen absorbers and special materials to prevent degradation
Solution Approach 1:
An oxygen absorber packet is introduced as an intermediary substance between the phenylephrine solution and atmospheric oxygen. This mediator prevents oxidation of the phenylephrine during storage without requiring terminal sterilization, thereby maintaining sterility and dosing accuracy while preventing chemical degradation through a separate mechanism.
Solution Approach 2:
The packaging system uses composite materials including multilayer polyolefin films and specialized oxygen-absorbing compounds. These composite materials provide both protective barriers against degradation and the necessary sterility maintenance, allowing the formulation to remain stable and sterile without terminal sterilization processes.
2Duration of action of stationary object
If phenylephrine is stored for 24 months or longer at room temperature, then extended shelf life is achieved, but the formulation may degrade physically and chemically without proper stabilization
Solution Approach 1:
The packaging system creates an inert environment by removing atmospheric oxygen through the oxygen absorber packet. This inert atmosphere prevents oxidation reactions during extended storage periods, maintaining the chemical stability of phenylephrine for 24 months or longer at room temperature without degradation.
Solution Approach 2:
The patent converts the harmful effect of oxygen (which causes oxidation and degradation) into a beneficial system by using oxygen absorbers. The oxygen that would otherwise cause chemical degradation is instead captured and removed by the absorber materials, transforming a harmful factor into a protective mechanism for long-term stability.
3Stability of the object's composition
If antioxidants like sodium metabisulfite or chelating agents like EDTA are added to phenylephrine formulations, then stability is improved, but contamination risks and additional costs increase
Solution Approach 1:
The patent extracts and removes the need for harmful additives like sodium metabisulfite and EDTA from the formulation. Instead of adding these stabilizing agents, the system uses physical packaging methods (oxygen absorbers and barrier materials) to achieve stability, thereby eliminating the contamination risks associated with these additives.
Solution Approach 2:
The patent replaces expensive and potentially harmful long-term stabilizing agents with disposable oxygen absorber packets. These single-use absorbers provide temporary protection during storage without requiring continuous presence in the formulation, eliminating contamination risks while maintaining stability throughout the shelf life.
4Reliability
If terminal sterilization is applied to phenylephrine formulations, then sterility is ensured, but the formulation may be compromised and dosing accuracy may be affected
Solution Approach 1:
The patent applies preliminary sterilization actions during the filling process rather than terminal sterilization after filling. The formulation is sterilized before packaging, and the sterile barrier is maintained through the packaging system itself, avoiding the need for terminal sterilization that could compromise the formulation and affect dosing accuracy.
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 solution provides a stable, ready-to-use phenylephrine formulation that maintains sterility and dosing accuracy, reducing contamination and overdosing risks, while being shelf-stable and compatible with infusion bags, suitable for prolonged storage and administration without reconstitution.
Implementation Method 1
packaged with an oxygen absorber that does not require sodium metabisulfite or another antioxidant or preservative or added chelating agent
Data Source
AI summary
The invention includes a phenylephrine product including an aqueous phenylephrine solution, a tonicity adjusting agent, at least one pH adjusting agent, at least one buffering agent and water for injection, wherein the phenylephrine solution is does not comprise sodium metabisulfite, wherein the phenylephrine product is sterile and ready-to-use and contain an oxygen absorber to keep the oxygen dissolved below 1 ppm. The invention includes methods of making and using the phenylephrine product.