Botulinum Toxin Prefilled Syringe Coating for Low-Force Delivery
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Solution Overview
Problem
Existing prefilled syringes for protein-based drugs like botulinum toxin face challenges in maintaining stability and functionality due to high sensitivity to pH, temperature, and chemical substances, leading to issues such as high sliding force, break loose force, and potential drug denaturation, which can result in inaccurate dosing and overdosing.
Innovation Solution
A botulinum toxin prefilled syringe system with a glass syringe barrel, plunger stopper, and closure device, featuring a normalized maximum gliding force of 20 N or less, low break loose force, and a lubricant layer to ensure smooth operation and stability over long-term storage, using fluoropolymer or silicone-free coatings to prevent drug interaction and degradation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional syringe materials are used to provide desired syringe functionality, then sliding force and break loose force are reduced, but protein-based drugs become unstable due to release of extractables and leachables
Solution Approach 1:
A lubricant layer is introduced as an intermediary substance between the plunger stopper and the syringe barrel. This lubricant layer reduces the sliding force to improve ease of operation while being chemically compatible with protein-based drugs, thereby preventing drug instability caused by extractables and leachables from conventional syringe materials.
2Reliability
If syringe materials compatible with protein stability are used, then drug stability is maintained, but sliding force and break loose force become too high
Solution Approach 1:
The lubricant layer serves as a mediator that decouples the relationship between syringe material compatibility and friction. It allows the use of chemically compatible syringe materials for maintaining drug stability while independently reducing break loose force and sliding force through its lubrication properties.
3Measurement precision
If prefilled syringes are used for botulinum toxin, then dosing accuracy and patient safety are improved, but injection force characteristics deteriorate with high gliding force and break loose force
Solution Approach 1:
The lubricant layer enables the prefilled syringe system to maintain dosing accuracy and patient safety benefits while resolving the injection force characteristics issue. By reducing gliding force, it allows for smoother plunger movement and more precise control during injection, eliminating the trade-off between dosing accuracy and ease of operation.
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 syringe system provides stable and accurate drug delivery with low gliding and break loose forces, ensuring convenient, safe, and precise administration of botulinum toxin over its shelf-life, minimizing waste and dosing errors.
Implementation Method 1
the inner surface of the syringe barrel is siliconized
Implementation Method 2
Botulinum toxin also generally has a high tendency to adsorb on syringe surfaces
Data Source
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AI summary
The present invention relates a botulinum toxin prefilled syringe system with desirable injection force characteristics, in particular low gliding force and low break loose force, comprising a syringe barrel of glass containing a liquid botulinum toxin composition, a plunger stopper and a closure device such as a tip cap or a needle shield. In addition, the present invention relates to a kit comprising the botulinum toxin prefilled syringe system, and optionally instructions for use, and to the use of the botulinum toxin prefilled syringe system in therapeutic and cosmetic applications.