Comprehensive characterization and evaluation are essential for ensuring the safety, performance, and clinical applicability of 3D-printed microneedle (MN) platforms. This chapter reviews key analytical and testing approaches used to assess the structural, mechanical, and functional properties of MN devices. Imaging techniques like high-resolution microscopy are discussed for their role in evaluating microneedle geometry, surface morphology, and fabrication fidelity, alongside mechanical testing methods such as nano-indentation to assess strength and insertion capability. The chapter further highlights recent innovations in drug loading and release evaluation, including real-time release tracking and microfluid-based models that enable dynamic performance assessment. Advanced biological evaluation platforms, such as three-dimensional skin models and organ-on-chip systems, are examined as physiologically relevant alternatives to conventional testing methods. Finally, progress toward clinical translation is discussed, with emphasis on recent human studies and evolving regulatory milestones, providing a perspective on the pathway from laboratory-scale evaluation to clinical implementation of 3D-printed microneedle technologies.

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Characterization and Evaluation of 3D-Printed Microneedles

  • Md Jasim Uddin

摘要

Comprehensive characterization and evaluation are essential for ensuring the safety, performance, and clinical applicability of 3D-printed microneedle (MN) platforms. This chapter reviews key analytical and testing approaches used to assess the structural, mechanical, and functional properties of MN devices. Imaging techniques like high-resolution microscopy are discussed for their role in evaluating microneedle geometry, surface morphology, and fabrication fidelity, alongside mechanical testing methods such as nano-indentation to assess strength and insertion capability. The chapter further highlights recent innovations in drug loading and release evaluation, including real-time release tracking and microfluid-based models that enable dynamic performance assessment. Advanced biological evaluation platforms, such as three-dimensional skin models and organ-on-chip systems, are examined as physiologically relevant alternatives to conventional testing methods. Finally, progress toward clinical translation is discussed, with emphasis on recent human studies and evolving regulatory milestones, providing a perspective on the pathway from laboratory-scale evaluation to clinical implementation of 3D-printed microneedle technologies.