Ready-to-Use Phenylephrine Formulation With Oxygen Absorber

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Solution Overview

Problem

Existing phenylephrine formulations face issues with physical and chemical degradation, require reconstitution or dilution before use, and contain antioxidants like sodium metabisulfite, leading to stability concerns and potential contamination risks.

Innovation Solution

A ready-to-use, sterile phenylephrine solution packaged with an oxygen absorber, free of sodium metabisulfite and other preservatives, in a compatible infusion container that maintains stability for 24 months without terminal sterilization.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Duration of action of stationary object

If phenylephrine formulations are stored for extended periods, then shelf-life is improved, but physical and chemical degradation occurs

Engineering Contradiction:

Improveshelf-lifeVSAvoidchemical stability

Core Design Contradiction:

Duration of action of stationary objectVSStability of the object's composition

Solution Approach 1:

The patent removes traditional antioxidants (sodium metabisulfite) and chelating agents (EDTA) from the formulation, extracting the harmful elements that cause degradation. This allows the phenylephrine to be stored without these additives while maintaining stability through alternative means including oxygen absorbers in the packaging.

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The patent introduces oxygen absorbers as intermediary substances in the packaging system. These oxygen absorbers act as mediators that prevent oxygen from reaching and degrading the phenylephrine, thereby extending shelf-life without requiring harmful chemical stabilizers in the formulation itself.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Stability of the object's composition

If phenylephrine is packaged with antioxidants and chelating agents, then stability is improved, but contamination risk and dosing errors increase

Engineering Contradiction:

Improveformulation stabilityVSAvoidcontamination risk

Core Design Contradiction:

Stability of the object's compositionVSReliability

Solution Approach 1:

The patent extracts and eliminates antioxidants and chelating agents from the phenylephrine formulation. By removing these substances, the patent reduces contamination risk and dosing errors associated with their presence, while maintaining stability through packaging-based protection (oxygen absorbers).

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The patent employs disposable oxygen absorbers in the packaging that are consumed during storage. These single-use oxygen absorbers provide continuous protection against oxidation throughout the shelf-life without requiring persistent chemical stabilizers in the formulation, thereby reducing contamination and dosing risks.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

3Quantity of substance

If phenylephrine requires reconstitution or dilution, then concentration control is improved, but preparation time and error risk increase

Engineering Contradiction:

Improveconcentration controlVSAvoidpreparation time

Core Design Contradiction:

Quantity of substanceVSLoss of time

Solution Approach 1:

The patent performs preliminary action by pre-diluting phenylephrine to the desired concentration and packaging it as a ready-to-use formulation. This eliminates the need for on-site reconstitution or dilution, thereby reducing preparation time and the associated risk of dosing errors while maintaining accurate concentration control.

Inventive Principle:

Principle #10Preliminary action

4Reliability

If terminal sterilization is applied, then sterility is improved, but product stability and compatibility deteriorate

Engineering Contradiction:

ImprovesterilityVSAvoidproduct stability

Core Design Contradiction:

ReliabilityVSStability of the object's composition

Solution Approach 1:

The patent replaces terminal sterilization (autoclaving) with aseptic processing techniques. Instead of using thermal mechanical sterilization that degrades the product, the patent employs filtration and sterile packaging methods to achieve sterility, thereby maintaining product stability and compatibility while ensuring sterility.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

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 avoids contamination and dosing errors, ensuring accurate administration and prolonged shelf-life without the need for reconstitution or dilution.

Implementation Method 1

packaged with an oxygen absorber that does not require sodium metabisulfite or another antioxidant or preservative or added chelating agent

Methodology Applied

Scientific EffectOxygen absorption: Absorption (physical)

Data Source

PatentUS12383497B2Ready-to-use phenylephrine formulations and products

Publication Date: 2025.08.12 INFORLIFE SA

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.