Dual-Chamber Pack Membrane Extraction for Contamination Control
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Solution Overview
Problem
Conventional dual-chamber packs for pharmaceutical compositions face issues with contamination, dosing errors, limited capacity, and stability due to membrane fragmentation and moisture permeation, particularly for high-dose and moisture-sensitive drugs.
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, where the plunger ensures the membrane adheres to the plug during activation, preventing contamination and maintaining content uniformity, and incorporating moisture barrier additives to prevent 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 active ingredient can be released into the vehicle upon activation, but membrane fragments may detach and contaminate the final product
Solution Approach 1:
The invention extracts the harmful membrane material from the final product by designing a system where the membrane remains attached to the plunger during activation. The plunger with attached membrane is withdrawn after piercing the seal, leaving no membrane fragments in the reconstituted solution.
Solution Approach 2:
The plunger acts as an intermediary that carries the membrane during activation. The membrane is transferred from its original position to the plunger, which then serves as a carrier to remove the membrane from the system without contaminating the final product.
2Stability of the object's composition
If the liquid composition permeates into the solid composition across the membrane during storage, then mixing occurs prematurely, but this leads to agglomeration of the solid composition and affects content uniformity
Solution Approach 1:
The invention performs preliminary sealing of the system before use. The membrane is positioned and sealed in advance to prevent any permeation during storage, ensuring complete separation until the moment of activation when the seal is intentionally broken.
3Stability of the object's composition
If the liquid composition permeates across the membrane during storage, then mixing occurs, but moisture-sensitive drugs lose stability
Solution Approach 1:
The system is pre-sealed with the membrane in place before storage. This preliminary sealing action prevents moisture permeation during the entire storage period, protecting moisture-sensitive drugs until activation occurs.
4Adaptability or versatility
If conventional dual-chamber packs are used, then two compositions can be stored separately and mixed at use, but the capacity is limited and not suitable for high-dose drugs or chronic administration
Solution Approach 1:
The invention segments the system into two distinct chambers (first chamber for vehicle, second chamber for solid composition) that can be scaled independently. This segmentation allows each chamber to be designed with appropriate capacity for high-dose applications while maintaining the separation and mixing functionality.
5Productivity
If the plunger is designed to rupture the membrane during activation, then mixing is achieved, but membrane fragments may fall into the final product causing contamination
Solution Approach 1:
The harmful membrane fragments are extracted from the final product by attaching them to the plunger. After the membrane is ruptured to enable mixing, the plunger with the membrane attached is withdrawn, taking the fragments out of the system and preventing contamination.
Solution Approach 2:
The plunger serves as an intermediary carrier that holds the membrane during the activation process. This intermediary role allows the membrane to be broken for mixing purposes while ensuring the fragments are removed with the plunger rather than falling into the product.
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
Ensures safe, contamination-free, and stable mixing of the active ingredient with the vehicle, suitable for high-dose and moisture-sensitive drugs, maintaining content uniformity and stability during storage and administration.
Implementation Method 1
the plug with the breakable polymeric membrane prevents permeation of moisture from the first chamber into 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 active ingredient remains in the dissolved or dispersed form in a pharmaceutically acceptable vehicle
Implementation Method 4
Liquid pharmaceutical compositions are generally in the form of a solution or a suspension
Data Source
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.