30 January 2024 | Daisuke Ando, Megumi Miyatsui, Hideyuki Sakoda, Eiichi Yamamoto, Tamaki Miyazaki, Tatsuo Koide, Yoji Sato and Ken-ichi Izutsu
This study investigates the factors affecting the mechanical strength of dissolving microneedles (MNs), focusing on their mechanical characterization. Dissolving MNs are a promising transdermal drug delivery system that can be self-administered without pain. The study used micromolding to fabricate PVA-based MN patches with eight different cone-shaped geometries. The mechanical properties of the MNs were evaluated using axial force mechanical characterization tests, which involved applying a force perpendicular to the base plate of the MN patches. The results showed that the needle fracture force was significantly affected by the compression speed and the number of needles compressed during the test. The fracture force decreased as the number of needles increased, and it was also negatively correlated with the aspect ratio of the needles. Additionally, higher residual water content or higher loading of lidocaine hydrochloride significantly decreased the needle fracture force. The study highlights the importance of setting appropriate methods and parameters for characterizing the mechanical properties of dissolving MNs to ensure their safety and effectiveness. The findings suggest that the mechanical strength of dissolving MNs is influenced by factors such as needle dimensions, water content, and drug content, and that these factors should be carefully considered in the design and evaluation of dissolving MNs. The study also emphasizes the need for standardized test methods and quality control protocols for dissolving MNs to ensure their consistent performance and safety.This study investigates the factors affecting the mechanical strength of dissolving microneedles (MNs), focusing on their mechanical characterization. Dissolving MNs are a promising transdermal drug delivery system that can be self-administered without pain. The study used micromolding to fabricate PVA-based MN patches with eight different cone-shaped geometries. The mechanical properties of the MNs were evaluated using axial force mechanical characterization tests, which involved applying a force perpendicular to the base plate of the MN patches. The results showed that the needle fracture force was significantly affected by the compression speed and the number of needles compressed during the test. The fracture force decreased as the number of needles increased, and it was also negatively correlated with the aspect ratio of the needles. Additionally, higher residual water content or higher loading of lidocaine hydrochloride significantly decreased the needle fracture force. The study highlights the importance of setting appropriate methods and parameters for characterizing the mechanical properties of dissolving MNs to ensure their safety and effectiveness. The findings suggest that the mechanical strength of dissolving MNs is influenced by factors such as needle dimensions, water content, and drug content, and that these factors should be carefully considered in the design and evaluation of dissolving MNs. The study also emphasizes the need for standardized test methods and quality control protocols for dissolving MNs to ensure their consistent performance and safety.