Dissolvable Microneedles with Their Design, Materials, and Limitations in Translation: a Technical Review.

Dissolvable microneedles (DMNs) have emerged as a groundbreaking drug delivery platform, offering a minimally invasive alternative to conventional parenteral and oral administration while enabling precise, pain-free, and patient-friendly therapeutic delivery. This review provides a comprehensive technical overview of the design, materials, and translational challenges of DMN systems. We begin by examining critical design parameters, including microneedle geometry, array configuration, mechanical strength, and drug distribution, that directly influence insertion efficiency, structural integrity, and dissolution kinetics. The role of mathematical modeling in optimizing DMN performance is also explored, offering insights into drug diffusion, structural mechanics, and dissolution kinetics. The materials section highlights the diverse natural and synthetic polymers used in DMN fabrication, along with additives and stabilizers that modulate drug release, improve biocompatibility, and ensure formulation stability. Despite significant advances in preclinical research, the translation of DMNs into clinical and commercial applications remains hindered by several factors, including limitations in drug loading capacity, manufacturing scalability, dose precision, long-term storage stability, and regulatory complexity. We also explore user-centric challenges, including ease of administration, patient compliance, and cost-effectiveness. The final section discusses current strategies to address these barriers, including the use of smart and stimuli-responsive polymers, next-generation microfabrication techniques, and packaging innovations designed to enhance shelf life and user handling. Through this, we aim to provide a critical perspective on the design, materials, and future potential of DMN technology, charting a path toward its successful integration into mainstream healthcare systems.