Multilayer Liquid Container Barrier Seal for Drug Stability
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Solution Overview
Problem
Soft bag pharmaceutical products face challenges with drug adsorption and permeation issues due to the use of certain resins, leading to storage stability and impact resistance problems, especially when containing drugs like nitroglycerin, proteins, hyaluronic acid, vitamins, and radical scavengers.
Innovation Solution
A multilayer film or sheet with a barrier layer made of polycycloolefin-based resin having a glass transition temperature higher than the thermal treatment or steam sterilization temperature, adjacent to a seal layer of polyethylene-based resin, enhances drug storage stability and impact resistance by preventing adsorption and permeation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a polyethylene-based resin layer is used as the seal layer in contact with the drug liquid, then the container exhibits good impact resistance and flexibility, but the drug components are adsorbed or permeated through the resin layer
Solution Approach 1:
The seal layer is divided into two functional sections: a polyethylene-based resin layer providing impact resistance and flexibility, and an adjacent polycycloolefin-based resin layer preventing drug adsorption and permeation. This segmentation allows each layer to perform its specific function without compromising the other.
Solution Approach 2:
The seal layer uses a composite structure combining polyethylene-based resin and polycycloolefin-based resin in adjacent layers. The polyethylene layer provides mechanical properties (impact resistance), while the polycycloolefin layer provides chemical stability (prevents drug interaction), creating a composite material system that achieves both requirements simultaneously.
2Reliability
If a polycycloolefin-based resin layer is used as the barrier layer, then the container prevents drug adsorption and permeation, but the resin exhibits high hardness and fragility
Solution Approach 1:
The container structure is segmented into distinct functional layers: the polycycloolefin-based resin layer serves as the barrier layer for drug stability, while the polyethylene-based resin layer provides impact resistance. This segmentation allows the brittle barrier material to be protected by the tougher outer layer.
Solution Approach 2:
Different regions of the container wall have different properties: the barrier layer has high chemical stability and low permeability to drugs, while the seal layer has high impact resistance and flexibility. Each layer is optimized for its specific local function rather than requiring the entire container to have all properties simultaneously.
3Reliability
If the seal layer thickness is reduced to minimize drug adsorption, then the amount of drug contact is reduced, but the mechanical strength and impact resistance are compromised
Solution Approach 1:
The seal layer is segmented into two functional zones: a thin polycycloolefin-based resin layer (5-50 μm) that minimizes drug contact and prevents permeation, and a thicker polyethylene-based resin layer that provides the necessary mechanical strength. This segmentation allows the barrier function to be achieved with minimal thickness while the structural function is handled by the thicker layer.
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 effectively prevents drug adsorption and permeation, maintaining storage stability and impact resistance, even under high-pressure steam sterilization and thermal treatment, making it suitable for soft bag pharmaceutical products.
Implementation Method 1
drugs including nitroglycerin, proteins (e.g., albumin and a hormone), hyaluronic acid, vitamins, trace elements, and radical scavengers are known to be adsorbed by or to permeate a film produced by molding vinyl chloride resin or a polyolefin-based resin
Implementation Method 2
drugs including nitroglycerin, proteins (e.g., albumin and a hormone), hyaluronic acid, vitamins, trace elements, and radical scavengers are known to be adsorbed by or to permeate a film produced by molding vinyl chloride resin or a polyolefin-based resin
Implementation Method 3
a multilayer film or sheet with a barrier layer made of polycycloolefin-based resin having a glass transition temperature higher than the thermal treatment or steam sterilization temperature, adjacent to a seal layer of polyethylene-based resin
Data Source
AI summary
To provide a liquid container, which exhibits excellent storage stability and impact resistance and which can be used for producing a soft bag pharmaceutical product of an injection liquid containing nitroglycerin, a protein, hyaluronic acid, a vitamin, a trace element, a radical scavenger, and the like. The liquid container of the invention formed of a multilayer film and/or multilayer sheet, characterized in that the multilayer film and/or multilayer sheet has a barrier layer containing, as a predominant component, a polycycloolefin-based resin having a glass transition temperature higher by 5°C or more than the temperature at which the container is subjected to thermal treatment or high-pressure steam sterilization, and a seal layer containing, as a predominant component, a polyethylene-based resin or a polypropylene-based resin, and the barrier layer being provided adjacent to the seal layer.