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Related Concept Videos

Factors Affecting Dissolution: Particle Size and Effective Surface Area01:23

Factors Affecting Dissolution: Particle Size and Effective Surface Area

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Dissolution kinetics, an essential aspect of oral drug delivery, is significantly influenced by the drug's particle size. According to the Noyes-Whitney dissolution model, the dissolution rate correlates directly with the drug's surface area. The larger the surface area, the higher the drug's solubility in water, leading to a faster drug dissolution rate. Reducing particle size increases the effective surface area, enhancing the dissolution process. Micronization and nanosizing are...
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Related Experiment Video

Updated: Apr 3, 2026

Fabrication of a Master Mold for Microneedles with a Micron-sized Air-vent Hole
06:25

Fabrication of a Master Mold for Microneedles with a Micron-sized Air-vent Hole

Published on: December 5, 2025

546

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
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 analysisDissolving microneedlesIn vitro drug permeationIn vitro drug releaseMechanical propertiesMicroneedle disintegrationMicroneedles

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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.