Flexible Biodegradable Microneedle Arrays for High Drug Loading
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Solution Overview
Problem
Existing microneedle arrays have limited drug loading capacity and lack flexibility, making them unsuitable for self-administration of drugs like loop diuretics, which require frequent hospital visits and are prone to infections with traditional administration methods.
Innovation Solution
A flexible microneedle array composed of biodegradable polymers like polylactic acid and polyglycolic acid, with a pharmaceutically active agent homogenously distributed, and a backing layer of alginate and polyol, allowing high drug loading and sustained release over 24 hours.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If microneedle arrays are made with traditional rigid materials and structures, then they can maintain structural integrity, but they lack flexibility making them unsuitable for patient self-administration
Solution Approach 1:
The microneedle array employs a flexible backing layer made of elastomeric material that can be repeatedly bent without cracking. This flexible substrate supports the microneedles while enabling the array to conform to body contours and be easily applied by patients, resolving the contradiction between flexibility and structural integrity.
2Quantity of substance
If microneedle arrays use conventional drug loading methods, then manufacturing is simpler, but drug loading capacity is limited and insufficient for treating conditions like congestive heart failure
Solution Approach 1:
The invention merges the drug incorporation step with the microneedle fabrication process by suspending the pharmaceutically active agent directly in the polymer solution before casting. This combined approach achieves high drug loading capacity (up to 40% w/w) without requiring separate, complex manufacturing steps.
Solution Approach 2:
The invention changes the concentration parameter of the drug in the polymer solution to achieve high drug loading. By optimizing the drug-to-polymer ratio in the suspension, the microneedles can contain significantly higher amounts of active agent while maintaining manufacturability through the same casting process.
3Reliability
If microneedles are made from non-biodegradable materials, then mechanical properties are more stable, but they require removal procedures increasing infection risk and treatment complexity
Solution Approach 1:
The microneedles are designed as biodegradable, single-use devices that decompose after drug delivery. The biodegradable polymer matrix provides sufficient mechanical stability during use, then safely degrades in the body, eliminating the need for removal procedures and associated infection risks.
Solution Approach 2:
The invention uses composite materials comprising biodegradable polymer and pharmaceutically active agent. This composite structure maintains adequate mechanical properties for skin penetration and drug delivery, while the biodegradable nature ensures safe degradation without requiring surgical removal.
4Quantity of substance
If drug is loaded only in microneedle tips, then application force is reduced, but drug loading capacity is insufficient for sustained release over 24 hours
Solution Approach 1:
The invention segments the drug distribution throughout the microneedle structure, incorporating active agent in the backing layer, shaft, and tip regions. This segmented distribution increases total drug loading capacity for sustained release while the overall microneedle design maintains acceptable application forces through optimized geometry and material properties.
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 array provides exceptional mechanical properties for safe patient application, enabling higher drug loading and controlled release, reducing the need for frequent hospital visits and minimizing infection risk.
Implementation Method 1
release the active agent, e.g., furosemide, in sustained fashion over at least 24 hours
Implementation Method 2
comprising a polyester selected from the group consisting cof polylactic acid, polyglycolic acid, poly(lactic-co-glycolic) acid
Implementation Method 3
said backing layer is flexible such that no cracks are formed when said microneedle array is bent over a central axis of said microneedle array by repetitively bringing together the opposing edges of the backing layer over 50 times
Implementation Method 4
said pharmaceutically active agent that is soluble in a solvent capable of dissolving said polyester
Data Source
AI summary
Disclosed herein are flexible microneedle arrays with improved characteristics, such as durability and high drug loading. Further disclosed methods of manufacturing the microneedle arrays, and uses thereof in treatment of a disease or a condition in a patient in need thereof.