Collapsible COP Packaging for Low-Permeation Drug Storage
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Solution Overview
Problem
Existing primary packagings for pharmaceutical liquids face issues with high water vapor permeability, contamination from additives, limited mechanical strength, and short storage duration, particularly in parenteral administration.
Innovation Solution
A primary packaging composed of a collapsible container with a connector element, utilizing cyclic olefin polymers for the first layer and optionally a fluoropolymer second layer, which provides enhanced barrier characteristics and mechanical strength, along with a septum or plug for secure liquid access and sealing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional plastics materials (polyvinyl chloride or ethylene vinyl acetate copolymer) are used for the container, then the packaging can be easily manufactured and sterilized, but the water vapor permeability is relatively high and additives can escape to contaminate pharmaceutical compositions
Solution Approach 1:
The patent applies composite materials by using a fluoropolymer layer (such as polyvinyl fluoride or polytetrafluoroethylene) in combination with cyclic olefin polymer. The fluoropolymer layer provides excellent barrier properties against water vapor and oxygen, while the cyclic olefin polymer provides structural integrity and ease of manufacturing. This composite structure resolves the contradiction by achieving low permeability without sacrificing manufacturability.
Solution Approach 2:
The patent changes the material parameters by selecting fluoropolymers with specific molecular structures and properties. The fluoropolymer layer has inherently low permeability to water vapor and oxygen due to its molecular structure, and the cyclic olefin polymer is selected for its chemical inertness and lack of additive migration. This parameter change resolves the contradiction by achieving both low permeability and contamination-free storage.
2Strength
If conventional plastics materials are used for the connector element, then the packaging can be easily manufactured, but the mechanical strength and tearing resistance are relatively low
Solution Approach 1:
The connector element is made from cyclic olefin polymer, which provides both high mechanical strength and good processability. The material's inherent properties allow for easy injection molding while maintaining high tearing resistance and mechanical strength, thus resolving the contradiction between strength and ease of manufacture.
Solution Approach 2:
The patent selects cyclic olefin polymer with specific molecular weight and composition parameters that optimize both mechanical strength and manufacturability. The material can be processed using conventional injection molding techniques while achieving the required mechanical properties, resolving the contradiction between strength and ease of manufacture.
3Duration of action of stationary object
If the primary packaging uses materials with high water vapor permeability, then the packaging can be easily manufactured and sterilized, but the storage duration of pharmaceutical agents is relatively limited
Solution Approach 1:
The fluoropolymer layer provides an excellent barrier against water vapor ingress, while the cyclic olefin polymer layer provides structural support and ease of manufacturing. This composite structure enables long-term storage of pharmaceutical agents by preventing water vapor penetration, thus resolving the contradiction between storage duration and permeability.
Solution Approach 2:
The patent changes the permeability parameters by using fluoropolymer materials with inherently low water vapor transmission rates. This material selection achieves both long storage duration and resistance to water vapor ingress without compromising manufacturability or sterilization capability.
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 packaging ensures prolonged storage of pharmaceutical agents by minimizing contamination and maintaining sterility, while meeting regulatory requirements and ensuring efficient filling and sealing processes.
Implementation Method 1
the materials that are commonly used still exhibit relatively high permeability to water vapor
Implementation Method 2
They are commonly formed from two foil parts which are welded together at their four sides
Data Source
AI summary
A primary packaging for a liquid is presented including an at least partially collapsible container and a connector element for connection of the primary packaging to a withdrawal device. The connector element has at least one connector channel which is in fluid communication with an interior space of the container. The container is composed at least partially of a foil which is constructed from a first layer which, during intended use of the primary packaging, comes into direct contact with the liquid. Both the first layer and the connector element are composed of a plastics material including at least one cyclic olefin polymer.