Dissolvable Microneedle Arrays With Precise Bioactive Dose Loading
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Solution Overview
Problem
Conventional microneedle-array based drug delivery systems face limitations in dosage control, fabrication complexity, and cost, which hinder their widespread application, particularly in delivering biologics and vaccines effectively.
Innovation Solution
The development of dissolvable microneedle arrays fabricated using micromilling technology, allowing for precise and efficient delivery of bioactive components, with a novel fabrication process that includes forming a mastermold and spin-casting material into a production mold, using biocompatible materials like carboxymethylcellulose, enabling rapid and low-cost production.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If solid or hollow microneedle arrays with no active component are used to pre-condition the skin, then skin permeability is significantly increased, but the ability to control dosage and quantity of delivered drugs is limited
Solution Approach 1:
The microneedle arrays are pre-loaded with bioactive components during fabrication, performing the drug loading action in advance. This eliminates the need for separate drug application steps and ensures precise dosage control from the outset, resolving the contradiction between skin permeability enhancement and dosage control capability
Solution Approach 2:
The invention merges the microneedle structure with the bioactive component into a single integrated device. The microneedles are fabricated with the active ingredient incorporated into their matrix, combining the physical penetration function with the drug delivery function, thereby achieving both skin permeability enhancement and precise dosage control simultaneously
2Manufacturing precision
If solid microneedles surface-coated with drug are used, then dosage control is improved, but the quantity of drug delivered is greatly limited
Solution Approach 1:
The invention changes the drug loading parameter from surface coating to bulk incorporation. By integrating the bioactive component throughout the microneedle matrix rather than just on the surface, the total drug capacity is dramatically increased while maintaining precise dosage control through controlled fabrication parameters
Solution Approach 2:
The microneedles are constructed as composite materials combining the structural matrix material with the bioactive component. This composite structure allows the active ingredient to be distributed throughout the microneedle body, significantly increasing the deliverable drug quantity while maintaining dosage precision through controlled composition ratios
3Productivity
If hollow microneedles attached to a reservoir of biologics are used, then delivery speed and precision as well as quantity of cargo are increased, but fabrication complexity and specialized application settings increase
Solution Approach 1:
The invention extracts and eliminates the complex reservoir attachment system from conventional hollow microneedle designs. By using solid microneedles with bioactive components directly incorporated into the matrix, the design removes the need for separate reservoirs, attachments, and complex filling procedures, thereby reducing fabrication complexity while maintaining delivery effectiveness
Solution Approach 2:
The microneedle arrays are designed as disposable, single-use devices with bioactive components integrated directly into the microneedle structure. This eliminates the need for complex, reusable reservoir systems that require specialized fabrication and maintenance, simplifying the overall system while enabling high-speed, precise delivery
4Manufacturing precision
If lithographic and laser-based technologies are used to create mastermolds, then geometric precision is achieved, but the range of geometric features and materials is limited and fabrication cost and time increase
Solution Approach 1:
The invention replaces lithographic and laser-based fabrication technologies with micro-molding techniques. This mechanical substitution allows for the creation of mastermolds using conventional machining methods that can produce a broader range of geometric features and are compatible with diverse materials, while reducing fabrication cost and time without sacrificing geometric precision
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 arrays provide painless and bloodless delivery of bioactive components to human skin, facilitating efficient and simultaneous delivery of antigens and adjuvants, with stable storage and transport capabilities, suitable for broad clinical deployment.
Implementation Method 1
a variety of microneedle-array based drug delivery devices have been developed. For example, one conventional method employs solid or hollow microneedles arrays with no active component. Such microneedle arrays can pre-condition the skin by piercing the stratum corneum and the upper layer of epidermis
Implementation Method 2
Yet another conventional method involves using solid microneedle arrays that are biodegradable and dissolvable
Implementation Method 3
This method combines the physical toughness of solid microneedles with relatively high bioactive material capacity
Data Source
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.