Multilayer Nano-Cell Transdermal Botulinum Toxin Delivery
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Solution Overview
Problem
Current methods for delivering botulinum neurotoxin, particularly for therapeutic and cosmetic applications, face challenges due to the large molecular weight of the toxin, leading to invasive and painful needle injections, and there is a risk of contamination from animal-derived ingredients used in fermentation processes.
Innovation Solution
A method involving the production of botulinum neurotoxin A with a small molecular weight using a non-animal-derived fermentation medium, followed by sequential purification using dialysis and chromatography, and encapsulating the toxin in multilayer nano-cells for transdermal delivery, which includes an innermost water phase core with biomolecules like hyaluronic acid and peptides, alternating oil and water phase layers, and an outermost cream layer for enhanced skin penetration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If needle injection is used to deliver botulinum neurotoxin, then the toxin can be delivered effectively, but the procedure becomes invasive, painful and unsafe with low patient compliance
Solution Approach 1:
The patent changes the physical parameters of the toxin by reducing its molecular weight through enzymatic degradation, transforming it from a large protein complex (960 kDa) to smaller fragments that can penetrate skin barriers. This parameter change enables transition from invasive injection to non-invasive transdermal delivery, resolving the contradiction between delivery effectiveness and patient compliance
Solution Approach 2:
The patent introduces an intermediary delivery system consisting of nanocapsules and transdermal patches that mediate between the toxin and the skin barrier. These intermediaries facilitate toxin penetration through the skin without requiring needle injection, thereby maintaining delivery effectiveness while improving patient compliance
2Productivity
If animal-derived ingredients are used in fermentation medium, then the botulinum toxin can be produced, but there is risk of viral contamination
Solution Approach 1:
The patent extracts and removes the harmful animal-derived components from the fermentation medium while retaining the essential nutrients needed for toxin production. By replacing animal-derived ingredients with synthetic or plant-based alternatives, the patent eliminates viral contamination risks while maintaining productivity
Solution Approach 2:
The patent employs disposable, single-use fermentation systems with defined synthetic media that eliminate the need for complex animal-derived ingredients. This approach reduces contamination risks while maintaining efficient toxin production through optimized synthetic nutrient formulations
3Reliability
If large molecular weight botulinum toxin is used, then the toxin maintains high potency, but it requires invasive needle injection for delivery
Solution Approach 1:
The patent segments the large molecular weight toxin into smaller fragments through controlled enzymatic degradation. This segmentation reduces the molecular weight to enable transdermal penetration while preserving the essential neurotoxic activity in the fragmented structure, thereby simplifying the delivery method from injection to topical application
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
This approach enables a safer, more efficient, and painless delivery of botulinum neurotoxin A, reducing the risk of contamination and improving patient compliance by utilizing a non-invasive transdermal method, while maintaining high potency and stability of the toxin.
Implementation Method 1
encapsulating the toxin in multilayer nano-cells for transdermal delivery, which includes an innermost water phase core with biomolecules like hyaluronic acid and peptides, alternating oil and water phase layers
Implementation Method 2
enables a safer, more efficient, and painless delivery of botulinum neurotoxin A, reducing the risk of contamination and improving patient compliance by utilizing a non-invasive transdermal method
Implementation Method 3
sequential purification using dialysis and chromatography
Implementation Method 4
sequential purification using dialysis and chromatography
Data Source
AI summary
A multilayer nano-cell includes an innermost water phase core including biomolecules in an aqueous solution; a first layer, including an oil phase layer encapsulating the innermost water phase core, thereby forming a water-in-oil structure, the oil phase layer including caprylic/capric triglyceride and macrogol-35-glycerol-rizinoleat; a second layer, including a water phase layer encapsulating the first layer, the water phase layer including hyaluronic acid, Cu-GHK tripeptide, palmitoyl-KTTKS pentapeptide, and hexapeptide argireline; a third layer, including another oil phase layer encapsulating the second layer; a fourth layer, including another water phase layer encapsulating the third layer; a fifth layer, including another oil phase layer encapsulating the fourth layer; and a sixth layer, including an outmost cream layer encapsulating the fifth layer.