Microneedle Patch With Diffusion-Proof Layer

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Solution Overview

Problem

Conventional transdermal drug delivery methods are not suitable for water-soluble drugs or vaccines due to the hydrophobic and negatively charged properties of the skin's stratum corneum, and existing microneedle patch manufacturing methods are complex, costly, and lack effective control over active ingredient distribution.

Innovation Solution

A microneedle patch with a substrate and needle parts featuring a diffusion-proof layer between the needle tip and base, composed of hyaluronic acid, polyvinylpyrrolidone, and carbohydrates, which controls the thickness and composition to limit active ingredients to the needle tip, preventing diffusion and ensuring accurate release.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If a conventional microneedle patch manufacturing method is used, then the patch can be produced, but the process complexity and cost increase due to multiple steps including adhesive application and alignment

Engineering Contradiction:
Improvemanufacturing process simplicityVSAvoidprocess steps
Core Design Contradiction:
Ease of manufactureVSDevice complexity

Solution Approach 1:

The invention merges the microneedle structure and drug reservoir into a single integrated body made of biodegradable polymer. The drug is embedded within the microneedle material itself during manufacturing, eliminating the need for separate adhesive application and alignment steps required in conventional methods where microneedles are attached to substrates separately.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The biodegradable polymer microneedle serves multiple functions simultaneously: it provides the structural needle component for skin penetration, acts as the drug reservoir through embedded active ingredients, and functions as the delivery mechanism. This multi-functionality consolidates what would otherwise require separate components and assembly steps.

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Manufacturing precision

If active ingredients are allowed to diffuse throughout the entire microneedle structure, then the microneedle maintains structural integrity, but the carrying quantity control is lost and active ingredients are wasted

Engineering Contradiction:
Improveactive ingredient distribution controlVSAvoidactive ingredient waste
Core Design Contradiction:
Manufacturing precisionVSLoss of substance

Solution Approach 1:

The invention implements local quality by concentrating the active ingredients specifically in the needle tip region where they are needed for drug delivery. The microneedle structure has non-uniform drug distribution with higher concentration at the tip and lower or zero concentration in the base, ensuring precise delivery to the target site while minimizing waste in non-functional regions.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The invention extracts the active ingredients from the entire microneedle structure and places them only in the specific region (needle tip) where they are needed for their intended function. This selective placement prevents diffusion throughout the whole structure and eliminates waste in areas where the ingredients would not contribute to therapeutic effect.

Inventive Principle:
Principle #2Taking out (Extraction)

3Ease of manufacture

If the microneedle patch uses a simple single-layer structure, then the manufacturing is easier, but the control over active ingredient release and delivery precision is insufficient

Engineering Contradiction:
Improvestructure simplicityVSAvoidactive ingredient localization
Core Design Contradiction:
Ease of manufactureVSManufacturing precision

Solution Approach 1:

The invention segments the microneedle structure into functionally distinct regions: the needle tip region containing concentrated active ingredients for delivery, and the base region providing structural support with minimal or no active ingredients. This segmentation within a single integrated structure enables precise active ingredient localization while maintaining manufacturing simplicity compared to multi-component assemblies.

Inventive Principle:
Principle #1Segmentation

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 microneedle patch effectively delivers active ingredients to the epidermis with controlled quantity and reduced waste, enhancing the delivery of both fat-soluble and water-soluble drugs and vaccines while maintaining mechanical strength to pierce the skin without breakage.

Implementation Method 1

a diffusion-proof layer of the needle part is formed between the needle tip and the base of the needle part; wherein the diffusion-proof layer of the substrate part and the diffusion-proof layer of the needle parts are one-piece structures

Methodology Applied
Scientific EffectDiffusion barrier: Diffusion Barrier

Data Source

PatentEP4129269B1Multi-layered microneedle patch and method of manufacturing the same
Publication Date: 2024.04.24 WIN COAT CORP
  • EP4129269B1 patent drawingFigure 1
  • EP4129269B1 patent drawingFigure 2
  • EP4129269B1 patent drawingFigure 3A

AI summary

Provided is a microneedle patch (1) comprising a substrate part (12) and multiple needle parts (11) protruding from the substrate part (12). The substrate part (12) consists of a diffusion-proof layer and a base, and each needle part (11) consists of a needle tip (111), a diffusion-proof layer and a base. The diffusion-proof layer of each needle part (112) is formed between the needle tip (111) and the base of the corresponding needle part (113). The diffusion-proof layer of the substrate part (122) and the diffusion-proof layer of needle part (112) are one-piece structures, and so are the base of the substrate part (123) and the base of the needle part (113). The diffusion-proof layer can prevent the active ingredients from diffusing to the base, limit the active ingredients to the needle tip and control the carrying quantity thereof.