Deformable Tray Microneedle Drug Delivery for Higher Payload Capacity
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Solution Overview
Problem
Existing microneedle technologies are limited by payload delivery capacity, incompatibility with existing automated filling lines, and difficulty in transitioning from lyophilized vial production to microneedle-based vaccines, necessitating a need for a versatile microneedle-based delivery system suitable for mass-production using standard equipment.
Innovation Solution
A freestanding microneedle technology with a deformable support and reservoir system, driven by posts that enhance penetration through skin engagement and utilize existing aseptic filling lines, allowing for controlled or sustained release of therapeutic agents.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If microneedle array patches are used to deliver drugs, then ease of handling and orientation are improved, but payload delivery capacity is limited due to small needle volume and incomplete penetration
Solution Approach 1:
The microneedle device is segmented into multiple individual needles arranged in an array, each capable of independent penetration. This segmentation allows the device to maintain ease of handling as a single unit while collectively delivering larger payloads through multiple penetration points simultaneously.
Solution Approach 2:
The microneedles are nested within a deformable backing layer that contains reservoirs. The needles can be fully inserted into the skin without being limited by the backing layer thickness, as the deformable material allows complete penetration while the reservoirs provide additional payload capacity.
2Force
If microneedles are made with larger aspect ratio to reduce insertion force, then ease of operation is improved, but penetration depth into skin is reduced due to skin stretching and elevation between needles
Solution Approach 1:
The backing layer is designed to be deformable rather than rigid, allowing it to dynamically adjust during penetration. As needles insert, the backing layer deforms to accommodate their movement, enabling full penetration depth without being constrained by the original thickness of the backing layer.
Solution Approach 2:
The deformable backing layer acts as a flexible substrate that can be stretched and deformed during the penetration process. This flexibility allows the microneedles to penetrate deeper into the skin than the initial thickness of the backing layer would suggest, as the material conforms to the penetration action rather than resisting it.
3Productivity
If existing automated aseptic filling lines are used for vaccine production, then productivity is improved, but compatibility with microneedle-based delivery systems is poor
Solution Approach 1:
The microneedle device is designed with universal features that allow it to be processed by existing automated aseptic filling lines. The device can be filled with vaccine formulations using standard filling equipment, and the deformable backing layer with integrated reservoirs can accommodate various filling methods, making the system compatible with current manufacturing infrastructure.
Solution Approach 2:
The deformable backing layer with reservoirs serves as an intermediary structure that bridges the gap between traditional liquid vaccine filling processes and solid microneedle delivery. The reservoirs can be filled with liquid vaccine using automated lines, and the microneedles can then deliver the payload from these reservoirs, combining the advantages of both liquid filling and solid needle delivery.
4Quantity of substance
If microneedles are coated with active ingredient to increase payload, then quantity of substance is improved, but manufacturing precision and control are reduced
Solution Approach 1:
The payload delivery system is segmented into separate components: the microneedles themselves and the reservoirs containing the active ingredient. This segmentation allows the reservoirs to be filled with precise amounts of drug using automated filling equipment, while the microneedles serve as the delivery mechanism, eliminating the need for difficult-to-control coating processes.
Solution Approach 2:
The reservoirs act as intermediaries between the filling process and the microneedle delivery system. They provide a controlled environment for containing and delivering the active ingredient, allowing for precise dosage control during manufacturing while simplifying the overall production process compared to direct coating of needles.
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
Enhances microneedle penetration depth and payload delivery, compatibility with existing vaccine production lines, and supports multiple formulations, reducing production costs and complexity.
Implementation Method 1
The deformable tray may be configured to adhesively engage the skin, thereby limiting the normal 'tenting' deformation of skin during penetration and thereby increasing control and uniformity of the microneedle penetration.
Implementation Method 2
moving the post structure relative to the deformable tray such that at least one post of the post structure moves toward an upper surface of the tray, through the at least one reservoir, and into at least one microneedle cavity so as to exert a force on contents of the at least one reservoir and to exert a force on a microneedle in the at least one cavity sufficient to drive the contents and the microneedle through the lower surface of the tray
Data Source
AI summary
A drug delivery device has a post structure having a base and at least one post protruding from the base. A deformable tray is movably coupled to the post structure and defines at least one cavity extending from an upper surface of the tray toward a lower surface of the tray. The at least one cavity tapers to a point at or near the lower surface of the tray. At least one microneedle is positioned within the at least one cavity. At least one reservoir is positioned directly above and axially aligned with the at least one cavity. The reservoir is configured to contain a therapeutic agent. An adhesive surface is positioned on the lower side of the deformable tray. The adhesive surface is configured to adhere to the skin and optionally remain on the skin when the microneedle device is withdrawn.


