Elastomeric Pharmaceutical Container With Thermoplastic Lining
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Solution Overview
Problem
Conventional pharmaceutical containers fail to provide adequate protection against moisture and gas penetration, leading to contamination and instability of medicinal compositions, and lack sufficient mechanical strength and resealability after needle puncture.
Innovation Solution
A flexible drug containment vessel made of pharmaceutical-grade thermoset elastomer rubber with an internal thermoplastic lining, providing a barrier against the elastomeric material and allowing for unique shapes, high resistance to breakage, and resealability after puncture, with features like multiple chambers and pneumatic expulsion of contents.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional medicine containers are used, then they are simple in structure and easy to manufacture, but they permit penetration of moisture or gas leading to contamination and instability
Solution Approach 1:
The container employs a composite structure consisting of an inner container made of flexible elastomeric material and an outer container made of rigid or semi-rigid material. This composite construction combines the flexibility and sealability of elastomers with the mechanical strength and barrier properties of the outer container, effectively preventing moisture and gas penetration while maintaining structural integrity.
Solution Approach 2:
The inner container is nested within the outer container, creating a multi-layer protective system. The inner elastomeric container provides flexibility and self-sealing capability, while the outer container provides structural support and additional barrier protection. This nested arrangement allows the container to maintain reliability without excessive complexity.
2Reliability
If conventional medicinal bags made of thermoplastic materials are used, then they are easy to manufacture, but they have issues with drug compatibility and lack sufficient barrier properties
Solution Approach 1:
The flexible elastomeric material used for the inner container combines drug compatibility with effective barrier properties against moisture and gas. This material selection resolves the contradiction by providing both the necessary chemical inertness for drug compatibility and the physical barrier properties needed, while still allowing for practical manufacturing processes.
3Strength
If conventional medicinal bags are used, then they are simple in structure, but they lack sufficient mechanical strength and resealability after needle puncture
Solution Approach 1:
The combination of flexible elastomeric inner container with rigid or semi-rigid outer container provides both the mechanical strength needed for needle puncture and resealability, while distributing the functional requirements across different material layers rather than requiring a single complex material system.
Solution Approach 2:
The flexible elastomeric inner container can deform to accommodate needle puncture and then return to its original shape, enabling self-sealing. This flexibility is combined with the structural support of the outer container to achieve both strength and resealability without excessive complexity.
4Reliability
If sealed vials with plastic or glass bodies are used, then they provide good protection, but they are rigid and cannot be compressed for expulsion of contents
Solution Approach 1:
The inner flexible elastomeric container provides the compressibility needed for content expulsion, while the outer rigid or semi-rigid container maintains structural integrity and protection. This composite approach allows the container to be compressed for expulsion while maintaining reliability and protection.
Solution Approach 2:
The flexible elastomeric inner container can be compressed to expel contents through a needle or access port, while the outer container provides structural support. This combination enables both the flexibility needed for compression and the protection required for reliable containment.
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 protects pharmaceutical compositions from contamination, maintains stability, and allows for efficient extraction and storage of multiple doses without compromising the container's integrity, even at extreme temperatures.
Implementation Method 1
a lining comprising a thermoplastic material covering at least a portion of an inner surface of the body portion... the lining is configured to provide a barrier between the elastomeric material and the pharmaceutical composition
Implementation Method 2
a body portion comprising an elastomeric material... provides a flexible containment structure
Implementation Method 3
provides high resistance to breakage, due to the strength of the elastomeric containment structure
Data Source
AI summary
A container for storing a pharmaceutical composition includes a body portion having an elastomeric material, and an inner lining having a thermoplastic material covering at least a portion of an inner surface of the body portion. The container forms an internal chamber for storing the pharmaceutical composition, where the internal chamber is bounded by the inner surface of the body portion. The inner lining provides a barrier between the elastomeric material and the pharmaceutical composition, thus protecting the pharmaceutical composition. Associated methods of storing the pharmaceutical composition within the container, as well as manufacturing the container, are also described.