Solvent-Cast Biodegradable Microneedle Arrays for Temperature-Sensitive Actives
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Solution Overview
Problem
There is a need for simpler and more effective methods to manufacture polymeric microneedle arrays, particularly those made of biodegradable polymers, that can operate at low temperatures to accommodate temperature-sensitive active ingredients.
Innovation Solution
The method involves creating an array of microprotrusions with a mold, casting a biocompatible solution comprising different polymers and an active ingredient, and avoiding bubble formation through various techniques such as surface treatments and pressure control, allowing for the production of arrays with multiple layers for enhanced drug delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If conventional microneedle array manufacturing methods are used, then manufacturing precision and structural integrity are improved, but device complexity and manufacturing cost increase
Solution Approach 1:
The manufacturing process is divided into distinct stages: mold preparation, solution casting, solvent removal, and demolding. Each stage is optimized independently to achieve high precision microneedle arrays while maintaining process simplicity. The mold itself is segmented into cavity structures that define the microneedle geometry.
Solution Approach 2:
The microneedle array structure is created by casting a solution into negative cavities of a mold, effectively copying the mold's cavity geometry into the final microneedle structure. This copying approach ensures high manufacturing precision while using simple, reusable molds.
2Ease of manufacture
If high temperature processing is used during manufacturing, then polymer processing and solvent removal are improved, but temperature-sensitive active ingredients are degraded
Solution Approach 1:
The manufacturing process uses low temperature parameters throughout. The solvent removal step is conducted at temperatures below those that would degrade temperature-sensitive actives, while still achieving complete solvent evaporation. This parameter optimization allows easy manufacturing of biodegradable polymers without thermal damage to active ingredients.
Solution Approach 2:
A biocompatible solvent acts as an intermediary medium that allows polymer processing and active ingredient incorporation at low temperatures. The solvent enables casting and shaping of the polymer matrix without requiring high temperature processing, thereby protecting temperature-sensitive components.
3Adaptability or versatility
If multiple layers with different polymers are incorporated, then drug delivery functionality and adaptability are improved, but manufacturing complexity increases
Solution Approach 1:
The microneedle array is constructed with multiple distinct layers, each containing different polymers and potentially different active ingredients. This segmentation allows each layer to be optimized for specific drug delivery functions while maintaining a relatively simple overall manufacturing process through sequential casting.
Solution Approach 2:
The multi-layer structure provides universal drug delivery functionality by accommodating different polymers and active ingredients in each layer. The same basic casting process can be used for each layer, making the manufacturing method universally applicable to various drug delivery configurations.
4Reliability
If disposable microneedle arrays are manufactured, then device reliability and ease of operation are improved, but manufacturing cost and productivity challenges arise
Solution Approach 1:
The microneedle arrays are designed as disposable single-use devices, manufactured using simple, low-cost processes. The biodegradable polymer construction and straightforward casting method enable economical production of disposable arrays that ensure device integrity and eliminate the need for sterilization and storage infrastructure.
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 the efficient and cost-effective production of biodegradable microneedle arrays that can deliver temperature-sensitive actives, improving skin penetration efficiency and ensuring the integrity of the drug delivery system.
Implementation Method 1
casting a solution comprising a biocompatible material and a solvent atop the mold. (c) removing the solvent
Data Source
AI summary
In an aspect of the invention, an array of microprotrusions is formed by providing a mold with cavities corresponding to the negative of the microprotrusions, casting atop the mold a first solution comprising a biocompatible material and a solvent, removing the solvent, casting a second solution atop the first cast solution, removing the solvent from the second solution, and demolding the resulting array from the mold. The first solution preferably contains an active ingredient.