Dual-Chamber Pack with Flexible Diaphragm for Drug Mixing
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Solution Overview
Problem
Conventional dual-chamber packs for pharmaceuticals face issues with contamination, limited capacity, and stability problems due to membrane fragmentation and moisture permeation, particularly for high-dose and moisture-sensitive drugs, which can lead to dosing errors and instability during storage.
Innovation Solution
A dual-chamber pack design with a prefilled container of pharmaceutically acceptable vehicle and a reservoir of solid active ingredient, featuring a biphasic connector, plunger, and breakable polymeric membrane that ensures complete mixing without membrane fragments entering the final product, maintaining content uniformity and stability by preventing moisture permeation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a breakable membrane is used to separate the two chambers, then the solid composition can be released into the liquid composition upon activation, but membrane fragments may detach and contaminate the final product
Solution Approach 1:
The disturbing element (breakable membrane) is extracted and replaced with a non-breakable flexible diaphragm that performs the separation function without fragmenting. The diaphragm is integrated with the plunger assembly, allowing it to be pushed into the first chamber to mix compositions without risking contamination from membrane fragments.
Solution Approach 2:
The invention uses a disposable dual-chamber pack where the entire assembly including the flexible diaphragm is designed for single use. This eliminates the need for the diaphragm to be durable across multiple uses, allowing optimization for low cost and single-use convenience while maintaining safety.
2Reliability
If the liquid composition is stored in contact with the solid composition across the membrane during storage, then the membrane provides separation, but liquid permeation through the membrane causes agglomeration of solid composition and affects content uniformity
Solution Approach 1:
The problematic permeable membrane is extracted and replaced with a flexible diaphragm that provides superior barrier properties. The diaphragm maintains complete separation between chambers during storage, preventing liquid permeation and solid composition agglomeration while allowing easy mixing upon activation.
Solution Approach 2:
The invention employs a flexible diaphragm made of elastomeric material that provides both separation integrity and flexibility. The diaphragm can be pushed into the first chamber to facilitate mixing while maintaining an effective barrier during storage to prevent composition permeation and maintain content uniformity.
3Ease of operation
If the membrane is made breakable to facilitate mixing, then the compositions can be combined upon activation, but the membrane may fragment and pose health hazards
Solution Approach 1:
The breakable membrane is extracted and replaced with a flexible diaphragm integrated into the plunger assembly. The diaphragm is pushed into the first chamber during activation to facilitate mixing without breaking or fragmenting, eliminating health hazards while maintaining mixing capability.
Solution Approach 2:
The flexible diaphragm made of elastomeric material provides both separation during storage and mixing capability upon activation. Its flexibility allows it to be pushed into the liquid composition to facilitate mixing while its integrity prevents fragmentation and health hazards.
4Device complexity
If the dual-chamber pack is designed with limited compartment capacity, then the structure remains simple, but it is not suitable for high-dose drugs or drugs requiring chronic administration
Solution Approach 1:
The dual-chamber pack is segmented into two separate chambers (first chamber for liquid composition, second chamber for solid composition) with distinct functions. This segmentation allows each chamber to be optimized for its specific purpose while maintaining overall structural simplicity and enabling high drug capacity through appropriate sizing.
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 dual-chamber pack ensures patient compliance, complete release of the solid composition, and stability of the active ingredient during storage, making it suitable for high-dose and moisture-sensitive drugs, while preventing contamination and maintaining the integrity of the final product.
Implementation Method 1
a breakable polymeric membrane... separating the liquid pharmaceutical composition in the first chamber from the solid composition of active ingredient in the second chamber
Implementation Method 2
The two compartments are separated by a breakable membrane which is ruptured by the depression of a plunger
Implementation Method 3
the solid composition of the active ingredient is mixed with the liquid pharmaceutical composition to form a liquid pharmaceutical composition
Data Source
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AI summary
The present invention relates to a dual-chamber pack with a first chamber comprising a container; and a second chamber comprising a reservoir, a biphasic connector, a plunger, and a plug with a breakable polymeric membrane. The container of the first chamber is prefilled with a pharmaceutically acceptable vehicle and the reservoir of the second chamber is prefilled with a solid composition of an active ingredient, wherein the solid composition of the active ingredient is mixed with the pharmaceutically acceptable vehicle to form a liquid pharmaceutical composition upon activation of the dual-chamber pack.