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Technical Challenges And Quality Considerations For Dissolving Microneedles.

Home
Technical Challenges And Quality Considerations For Dissolving Microneedles.

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Published on: December 5, 2025

Technical challenges and quality considerations for dissolving microneedles.

Nahid S Kamal¹, Samuel Acheampong¹, Rokon Uz Zaman¹

¹Office of Pharmaceutical Quality Research, Office of Pharmaceutical Quality (OPQ), CDER, FDA, USA.

International Journal of Pharmaceutics

|April 1, 2026

View abstract on PubMed

Summary

This summary is machine-generated.

Optimizing polyvinyl alcohol (PVA) concentration in dissolving microneedles (DMNs) enhances structural integrity and controls drug release. The polymer-to-API ratio impacts drug distribution and release kinetics for improved transdermal delivery systems.

Keywords:

Artificial intelligence assisted image analysis Dissolving microneedles In vitro drug permeation In vitro drug release Mechanical properties Microneedle disintegration Microneedles

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Polymeric Microneedle Array Fabrication by Photolithography

Polymeric Microneedle Array Fabrication by Photolithography

Published on: November 17, 2015

Area of Science:

Pharmaceutical Sciences
Biomaterials Engineering
Drug Delivery Systems

Background:

Dissolving microneedles (DMNs) offer transdermal drug delivery by penetrating the stratum corneum.
Challenges exist in optimizing DMN formulations for mechanical properties and drug release.
Lack of standardized quality control hinders DMN product development.

Purpose of the Study:

To investigate testing methods for DMNs.
To evaluate the impact of polymer-to-API ratio on DMN critical quality attributes (CQAs).
To understand how CQAs influence drug release and skin permeation.

Main Methods:

DMNs formulated with varying polyvinyl alcohol (PVA) concentrations and metoprolol succinate.
Microscopic imaging with AI segmentation for morphological analysis.

Intensity-distance analysis for drug distribution assessment.

Mechanical testing (fracture force) and in vitro drug release/permeation studies.

Main Results:

Pyramidal DMNs with consistent dimensions were successfully fabricated.
Increased PVA content enhanced microneedle fracture force and structural integrity.
Polymer-to-API ratio did not affect skin insertion or disintegration.
Higher PVA content slowed drug release, identifying polymer as a key release controller.
Drug permeation correlated with spatial drug distribution within the microneedles.

Conclusions:

Optimizing the PVA-to-drug ratio is crucial for controlling DMN drug release and permeation.
Controlling drug distribution within DMNs is essential for enhancing transdermal delivery performance.
Standardized testing methods are needed to address quality control challenges in DMN development.