The transdermal delivery of nanoparticle-based biomolecules is limited by the skin barrier and instability during microneedle fabrication. In conventional single-layer dissolving microneedles, drug loading induces particle aggregation and weakens mechanical strength. To overcome this, a double-layered dissolving microneedle (DMN) was developed with drug-loaded lower and reinforced upper layers. DMNs were fabricated by a two-step casting process using conical PDMS molds. Upper layer consisted of polyvinylpyrrolidone (PVP K-30) and polyvinyl alcohol (PVA 500) at ratios of 1:0.5, 1:1, and 1:2, while the lower layer contained sodium hyaluronate (HA; 5, 10, and 15%) and nanoparticles (0.005, 0.05, and 0.5%). Microneedle morphology, mechanical strength, and penetration capability were evaluated using a microscope, texture analyzer, and parafilm insertion tests, while nanoparticle stability and transdermal delivery were assessed by dynamic light scattering and Franz diffusion studies. A PVP K-30/PVA 500 ratio of 1:0.5 provided optimal bending resistance. Uniform lower-layer filling was achieved with 15% HA, and 0.05% nanoparticle loading maintained stability below 200 nm without aggregation. The optimized DMN showed sufficient insertion capability, and Franz diffusion studies confirmed approximately 14.9% membrane permeation. This double-layered architecture effectively separates mechanical support and drug loading functions, improving nanoparticle stability and transdermal delivery.
2026 Spring Convention