Dissolvable Microneedle Arrays With Micromilled Molds for Dosage Control

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Solution Overview

Problem

Conventional microneedle-array based transdermal drug delivery systems face limitations in controlling dosage, quantity, and complexity in fabrication and testing, particularly in creating geometric features and materials for efficient bioactive molecule delivery.

Innovation Solution

The development of dissolvable microneedle arrays using micromilling techniques for producing mastermolds and spin-casting bioactive components, enabling flexible, rapid, and cost-effective production with precise control over microneedle geometry and bioactive delivery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If conventional lithographic and laser etching technologies are used to create mastermolds, then geometric features and material precision are improved, but fabrication complexity and cost increase significantly

Engineering Contradiction:
Improvegeometric features precisionVSAvoidfabrication complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The patent replaces complex lithographic and laser-based fabrication systems with a micromolding system that uses a simple mastermold. The mastermold is created once using conventional techniques, then used to produce multiple microneedle arrays through a straightforward molding process, eliminating the need for repeated complex lithographic and laser etching operations.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent creates a mastermold that serves as a template for producing multiple production molds, which in turn generate numerous microneedle arrays. This copying approach allows precise geometric features to be replicated across many units without repeating the complex fabrication process for each individual array.

Inventive Principle:
Principle #26Copying

2Quantity of substance

If hollow microneedles with reservoirs are used, then delivery quantity and precision are improved, but device complexity and fabrication difficulty increase

Engineering Contradiction:
Improvedelivered cargo quantityVSAvoidfabrication complexity
Core Design Contradiction:
Quantity of substanceVSDevice complexity

Solution Approach 1:

The patent combines the microneedle structure with the drug reservoir into a single integrated solid microneedle array. The bioactive components are incorporated directly into the microneedle material matrix, eliminating the need for separate hollow reservoirs and complex attachment mechanisms while maintaining controlled delivery capability.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The patent uses composite materials where bioactive components are embedded within the microneedle structure itself. This integration allows the microneedles to function both as structural elements for skin penetration and as reservoirs for drug delivery, simplifying the overall device architecture.

Inventive Principle:
Principle #40Composite materials

3Manufacturing precision

If surface-coated solid microneedles are used, then dosage control is improved, but delivered quantity is limited

Engineering Contradiction:
Improvedosage controlVSAvoiddelivered cargo quantity
Core Design Contradiction:
Manufacturing precisionVSQuantity of substance

Solution Approach 1:

The patent changes the parameter of drug incorporation from surface coating to bulk integration. By incorporating bioactive components throughout the entire microneedle volume rather than just on the surface, the system maintains precise dosage control through material composition while dramatically increasing the total drug payload capacity.

Inventive Principle:
Principle #35Parameter changes

4Ease of manufacture

If dissolvable microneedle arrays are used, then ease of manufacture and storage are improved, but manufacturing precision and geometric control were previously limited

Engineering Contradiction:
Improvefabrication simplicityVSAvoidgeometric features precision
Core Design Contradiction:
Ease of manufactureVSManufacturing precision

Solution Approach 1:

The patent uses a mastermold that precisely defines the desired microneedle geometry. This mastermold is then used to create production molds that replicate the precise geometric features across many microneedle arrays, maintaining high manufacturing precision while keeping the fabrication process simple and suitable for dissolvable materials.

Inventive Principle:
Principle #26Copying

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 allows for efficient, precise, and reproducible delivery of bioactive molecules to the skin, minimizing pain and bleeding, and enabling simultaneous delivery of antigens and adjuvants, with stable storage and distribution capabilities, making it suitable for broad clinical deployment.

Implementation Method 1

micromilling a mastermold to create a female production mold

Methodology Applied
Scientific EffectMaterial removal through micromilling: Abrasion

Implementation Method 2

spin-casting material (including bioactive components) into the production mold

Methodology Applied
Scientific EffectSpin casting: Spin Coating

Implementation Method 3

dissolvable microneedle arrays that can provide efficient, precise, and reproducible delivery of biologically active molecules

Methodology Applied
Scientific EffectDissolution: Solvation

Data Source

PatentUS11744927B2Dissolvable microneedle arrays for transdermal delivery to human skin
Publication Date: 2023.09.05 UNIV OF PITTSBURGH OF THE COMMONWEALTH SYST OF HIGHER EDUCATION
  • US11744927B2 patent drawing
  • US11744927B2 patent drawing
  • US11744927B2 patent drawing

AI summary

A method of forming a microneedle array can include forming a sheet of material having a plurality of layers and micromilling the sheet of material to form a microneedle array. At least one of the plurality of layers can include a bioactive component, and the microneedle array can include a base portion and plurality of microneedles extending from the base portion.