Pharmaceutical Bottle with Large Headspace for Complete Drug Transfer
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Solution Overview
Problem
Current packaging systems for intravenous pharmaceutical compositions, particularly those containing highly active drugs like Tacrolimus, face challenges in ensuring complete transfer of the drug into the infusion liquid while minimizing risk to healthcare personnel and reducing waste and overdosing, due to incomplete transfer and the cost and complexity of ampoule production.
Innovation Solution
A packaging system utilizing bottles with a large empty volume of 80-99% capacity, designed to facilitate complete transfer of pharmaceutical compositions into intravenous infusion liquids, using connectors with perforating spikes and collapsible containers to ensure safe and efficient administration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional ampoules are used for packaging highly active drugs, then safety for healthcare personnel is improved through direct connection systems, but complete transfer of the drug into infusion liquid is not achieved and waste occurs
Solution Approach 1:
The invention changes the volume parameter of the packaging container from traditional ampoule sizes to larger bottles with 80-99% empty volume. This parameter change enables complete wash-out transfer of the drug into the infusion bag while maintaining safety through the same connector system, resolving the contradiction between safety and complete transfer.
Solution Approach 2:
The invention transitions from small-volume ampoules to large-volume bottles with significant headspace, adding a dimensional aspect of volume ratio. This dimensional change allows the infusion liquid to effectively wash out and retrieve all drug residues, achieving complete transfer while maintaining the safety benefits of direct connection.
2Loss of substance
If syringe transfer method is used, then complete transfer of drug can be achieved, but risk of accidental pricking and contact with toxic drug increases for healthcare personnel
Solution Approach 1:
The invention extracts and eliminates the syringe and needle components from the transfer system, replacing them with a direct connector system that links the bottle directly to the infusion bag. This extraction removes the source of accidental pricking while maintaining complete drug transfer through the wash-out mechanism enabled by the large empty volume bottle.
Solution Approach 2:
The invention introduces a connector as an intermediary device that mediates the transfer process between the bottle and infusion bag. This intermediary enables direct liquid flow and complete drug transfer without requiring syringes or needles, thereby eliminating the risk of accidental pricking while achieving complete transfer.
3Reliability
If overdosing is used to minimize risk of underdosing, then patient safety regarding insufficient dosage is improved, but waste of expensive active principle and risk of overdosing increases
Solution Approach 1:
The invention creates a feedback mechanism where the large empty volume bottle allows complete retrieval of the drug through wash-out. The system feedback ensures that all drug is transferred to the infusion bag, eliminating the need for empirical overdosing strategies and enabling precise dosing without waste or risk of underdosing.
Solution Approach 2:
The invention replaces the mechanical syringe transfer system with a fluid dynamic wash-out system. The large empty volume enables the infusion liquid to flow through and retrieve all drug residues, substituting the mechanical withdrawal method with a fluid-based complete transfer mechanism that eliminates both waste and dosing uncertainty.
4Object-affected harmful factors
If connectors with perforating spikes are used for direct connection, then safety for healthcare personnel is improved, but complete transfer of pharmaceutical composition into infusion liquid is not achieved
Solution Approach 1:
The invention merges two previously separate systems: the safe direct connection system (connectors with spikes) and the complete transfer system (large empty volume bottles). By combining these elements, the invention achieves both safety through direct connection and complete transfer through the wash-out mechanism enabled by the bottle's large headspace.
Solution Approach 2:
The invention prepares the system in advance by using bottles with 80-99% empty volume from the outset. This preliminary configuration of the packaging system ensures that when the connector is applied and the wash-out process begins, complete drug transfer is automatically achieved, combining safety and completeness in a pre-configured system.
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 system achieves over 99% transfer of the active principle in a single wash, reducing the risk of accidental contact and overdosing, while minimizing waste and production costs, and ensuring the exact dosage is administered safely and efficiently.
Implementation Method 1
the liquid for infusion which is pushed upwards by compression of the infusion container, which in this case is made of collapsible material
Data Source
AI summary
The invention refers to a new system for packaging pharmaceutical compositions comprising active principles that may be administered intravenously, in particular it concerns a system for packaging in bottles which makes it possible to ensure the complete transfer of the content of the bottle into the liquid for intravenous infusion and at the same time prevent any accidental contact with the active principle by the health-care personnel preparing said intravenous infusion, and a complete kit for intravenous administration.