School of Pharmacy, Queen's University Belfast, 97 Lisburn Road, Belfast, BT9 7BL, UK.
Drug Deliv Transl Res. 2022 Apr;12(4):838-850. doi: 10.1007/s13346-021-01033-1. Epub 2021 Jul 31.
Although microneedle array patch (MAP) technology is reaching ever closer to regulatory approval, it remains imperative that approaches to further improve patient acceptance are still explored. Addressing this perception, a water-filled reservoir was incorporated into a hydrogel-forming MAP system to provide a novel feedback mechanism. To confirm successful MAP skin insertion, the end user would both hear and feel the rupture of the water-filled reservoir. Interestingly, a 50-µL water-filled reservoir ruptured at 30.27 ± 0.39 N, which has previously been shown as the mean application force for MN insertion in human subjects following appropriate instruction. Importantly, no significant difference in % cumulative permeation of FITC-dextran 10 kDa and fluorescein sodium after 24 h was observed between a 50-µL reservoir and the current method of application that has been successfully used in both in vitro and in vivo studies (p > 0.05). Therefore, as drug delivery was not affected, this proof-of-concept study has shown that a water-filled reservoir feedback mechanism has the potential to serve as a viable tool for consistent MAP skin insertion.
尽管微针贴片（MAP）技术已越来越接近监管部门的批准，但仍有必要探索进一步提高患者接受度的方法。为了解决这一问题，我们在水凝胶形成的 MAP 系统中加入了一个充满水的储液器，以提供一种新的反馈机制。为了确认 MAP 皮肤插入的成功，最终用户将同时听到和感觉到充满水的储液器的破裂。有趣的是，50 μL 的充满水的储液器在 30.27 ± 0.39 N 处破裂，这已经被证明是在适当指导下，人体 MN 插入的平均应用力。重要的是，在 24 小时后，FITC-葡聚糖 10 kDa 和荧光素钠的累积渗透率之间没有观察到 50 μL 储液器和当前已成功用于体外和体内研究的应用方法之间有显著差异（p > 0.05）。因此，由于药物输送没有受到影响，这项概念验证研究表明，充满水的储液器反馈机制有可能成为一种可行的工具，用于实现一致的 MAP 皮肤插入。
