Amphiphilic Interlayers for Oxygen-Barrier COP/COC Containers
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Solution Overview
Problem
COP or COC based pharmaceutical containers suffer from high oxygen gas permeability, leading to degradation of oxygen-sensitive medications and potential drug shortages due to poor adhesion between hydrophilic and hydrophobic polymer layers.
Innovation Solution
A triple-layered polymer structure is introduced, comprising cyclic olefin polymers or copolymers as outer layers and an amphiphilic polymer as the middle layer with specific Hansen Solubility Parameter distances, enhancing adhesion and oxygen barrier properties.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If hydrophilic polymers with high oxygen barrier properties (such as EVOH) are co-injection molded onto the outer surfaces of COP/COC containers, then oxygen barrier properties are improved, but adhesion between layers deteriorates due to poor bonding between hydrophilic polymer and hydrophobic COP/COC surfaces
Solution Approach 1:
The patent introduces a hydrophobic polymer layer as an intermediary between the hydrophobic COP/COC container and the hydrophilic oxygen barrier polymer. This intermediate layer acts as a mediator that is compatible with both the hydrophobic container surface and the hydrophilic barrier layer, enabling strong interlayer adhesion while maintaining the oxygen barrier properties of the hydrophilic polymer.
Solution Approach 2:
The patent creates a multi-layer composite structure consisting of COP/COC outer layers, a hydrophobic polymer interlayer, and a hydrophilic oxygen barrier polymer. This composite material approach combines materials with different properties (hydrophobic and hydrophilic) in a layered configuration, allowing each layer to perform its specific function while maintaining strong interlayer bonding through the hydrophobic intermediate layer.
2Strength
If COP or COC containers are used, then break resistance and pH stability are improved, but oxygen gas permeability increases leading to medication degradation
Solution Approach 1:
The patent creates a multi-layer composite structure where the outer COP/COC layers provide mechanical strength and break resistance, while the inner hydrophilic oxygen barrier polymer layer blocks oxygen gas permeability. This composite approach allows the container to simultaneously achieve high mechanical strength from the COP/COC layers and low oxygen permeability from the hydrophilic barrier layer, preventing medication degradation.
Solution Approach 2:
The patent segments the container wall into multiple functional layers: outer COP/COC layers for mechanical strength and break resistance, and an inner hydrophilic polymer layer for oxygen barrier properties. This segmentation allows each layer to independently perform its specific function, with the COP/COC layers providing structural integrity and the inner layer providing oxygen protection, thereby solving the problem of high oxygen permeability in single-material COP/COC containers.
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 layered structure significantly reduces gas permeability, allowing for longer storage of oxygen-sensitive therapeutics by effectively blocking oxygen ingress.
Implementation Method 1
The amphiphilic polymer used in the interlayer has a hydrophilic component with a Hansen Solubility Parameter distance of 8 MPa1/2 or greater from oxygen gas, while at the same time having a hydrophobic component with a Hansen Solubility_parameter distance of 8 MPa1/2 or less from COC or COP
Data Source
AI summary
Layered polymer materials include a first layer including a first cyclic olefin polymer or a first cyclic olefin copolymer, a third layer including a second cyclic olefin polymer or a second cyclic olefin copolymer, and a second layer including an amphiphilic polymer having a hydrophilic component with a Hansen Solubility Parameter distance of 8 MPa1/2 or greater from oxygen gas, while at the same time having a hydrophobic component with a Hansen Solubility Parameter distance of 8 MPa1/2 or less from COC or COP. The second layer can be in contact with and be between the first layer and the third layer. The layered polymer material can be used to construct the body of a vial or a syringe. Methods of making the layered polymer material and kits containing the layered polymer material or containers having a body constructed from the layered polymer material are also described.