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Related Concept Videos

Confocal Fluorescence Microscopy01:16

Confocal Fluorescence Microscopy

Confocal microscopy is an advanced microscopic technique. The prime advantage of the confocal microscope over other microscopy techniques is its ability to block the out-of-focus light from the illuminated samples using pinholes. It is widely used with fluorescence optics to obtain high-resolution, sharp contrast images. Unlike optical microscopes, confocal microscopes use a focused beam of light laser to scan the entire sample surface at different z-planes. These microscopes are, therefore,...

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Deep-Learning-Enabled SEM Image Segmentation Coupled with Laser Confocal Raman Microscopy: Elucidating Microstructure

Wei Zhang1,2, Zhihong Xu1,3, Li Jiang1

  • 1Innovation Center of Advanced Drug Delivery System and Biotech Drugs in Universities of Shandong, Key Laboratory of Molecular Pharmacology and Drug Evaluation, Ministry of Education, School of Pharmacy, Yantai University, Yantai 264005, China.

Pharmaceuticals (Basel, Switzerland)
|June 26, 2026
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Summary
This summary is machine-generated.

Novel methods using SEM-DLIS and LCRS precisely characterize microsphere microstructure and API distribution. This reveals how structure, including pore size and API location, dictates drug release kinetics for sustained-release formulations.

Keywords:
deep learning image segmentationdrug distributionlaser confocal Raman spectroscopymicrospherespore structurescanning electron microscopy

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Analytical Chemistry

Background:

  • Characterizing microsphere microstructure and physicochemical properties is crucial for understanding drug release.
  • Current methods face limitations in providing in-depth analysis of the process-structure-performance relationship.

Purpose of the Study:

  • To develop and validate novel methods for detailed microstructural and physicochemical characterization of sustained-release microspheres.
  • To establish a link between microsphere attributes and drug release mechanisms.

Main Methods:

  • Scanning electron microscopy (SEM) combined with deep learning-based image segmentation (DLIS) for pore structure analysis.
  • Laser confocal Raman spectroscopy (LCRS) for in situ, non-destructive 3D visualization and mapping of active pharmaceutical ingredient (API) distribution.

Main Results:

  • SEM-DLIS quantified significant variations in pore structure across different manufacturers and particle sizes.
  • LCRS identified diverse API distribution patterns (uniform, outer-layer enriched, heterogeneous).
  • Initial burst release correlates with surface porosity and API surface enrichment; sustained release depends on internal pores, particle size, and API distribution.

Conclusions:

  • Microsphere microstructure directly dictates drug release behavior.
  • Structural variations are linked to critical process parameters (CPPs), supporting the "process determines structure" hypothesis.
  • The developed methodology enables reverse engineering, quality assessment of generics, and optimization of novel drug products.