Lee Jing Yi, Dong Shi Hui, Ng Keng Wooi, Goh Choon Fu
Discipline of Pharmaceutical Technology, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Minden, Penang, 11800, Malaysia.
School of Pharmacy, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, NE1 7RU, UK.
Drug Deliv Transl Res. 2025 May 31. doi: 10.1007/s13346-025-01888-8.
With the rapid advancements in microneedle technology, the translation of microneedles to end users is now achievable. However, concerns about microneedle product quality persist due to the absence of standard guidelines. This study aims to evaluate the integrity, mechanical properties and skin penetration performance of commercially available polymeric-based cosmetic microneedle patches. The patches were characterised for needle geometry/dimension, mechanical strength and insertion capabilities using in vitro Parafilm M and ex vivo porcine skin models. Ten microneedle patches investigated have needle height of ~ 180-500 μm, base width of ~ 100-270 μm and interneedle spacing of ~ 320-686 μm with fracture force up to 14 N. Some microneedles showed deformed needles due to poor packaging protection. Despite most microneedle patches showed good insertion into Parafilm M, only 7 patches demonstrated ex vivo porcine skin insertion in OCT analysis. Nevertheless, only 1 microneedle patch demonstrated full skin insertion ratio due to a lower needle density. This study highlights the critical role of needle geometry, mechanical properties and packaging in ensuring microneedle functionality. More importantly, microneedle products are a significant 'innovation' that must prioritise puncture performance and packaging to ensure effectiveness and avoid being dismissed as a mere 'fad'.
随着微针技术的迅速发展，微针现在已能够应用于终端用户。然而，由于缺乏标准指南，对微针产品质量的担忧依然存在。本研究旨在评估市售聚合物基美容微针贴片的完整性、机械性能和皮肤穿透性能。使用体外Parafilm M和离体猪皮模型对贴片的针几何形状/尺寸、机械强度和插入能力进行了表征。所研究的10种微针贴片的针高约为180 - 500μm，基部宽度约为100 - 270μm，针间距约为320 - 686μm，断裂力高达14N。一些微针由于包装保护不佳而出现针变形的情况。尽管大多数微针贴片在Parafilm M中显示出良好的插入效果，但在OCT分析中，只有7种贴片在离体猪皮上实现了插入。然而，由于针密度较低，只有1种微针贴片实现了完全皮肤插入率。本研究强调了针的几何形状、机械性能和包装在确保微针功能方面的关键作用。更重要的是，微针产品是一项重大的“创新”，必须优先考虑穿刺性能和包装，以确保有效性，避免被视为仅仅是一种“时尚”而遭摒弃。
