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Microneedle patch designs to increase dose administered to human subjects
Journal of Controlled Release ( IF 10.5 ) Pub Date : 2021-09-29 , DOI: 10.1016/j.jconrel.2021.09.036
Wei Li 1 , Song Li 2 , Xiyi Fan 2 , Mark R Prausnitz 2
Affiliation  

Microneedle (MN) patches are being developed for many different kinds of drugs, but are often limited to delivering sub-milligram doses. This is because larger patches can be more difficult to apply to the skin, and acceptability of larger MN patches by human subjects has received limited study. Here, we fabricated 18 different large MN patch designs by laser microfabrication with different MN length (800–1500 μm), number of MNs (225 to 900 MNs per patch), space between MNs (600–1100 μm), and MN base diameter (200–250 μm). After manual application of these patches to human participants, we assessed dose delivery efficiency, total dose delivered, dose delivered per MN, depth of MN penetration and whole-MN delivery efficiency. We found that all of these parameters generally increased with decreased MN length, increased number of MNs (among those ≤1000 μm in length) and increased MN-MN spacing. All MN patch designs caused less pain than a pin prick sensation and were generally considered acceptable by the study participants. The MN patches induced mild, or sometimes moderate, transient erythema on skin. Study participants showed higher preference for MN patches for long-acting contraception compared with conventional options, indicating strong interest and acceptability of MN patches in this study.



中文翻译:

微针贴片设计以增加对人类受试者的给药剂量

正在为许多不同种类的药物开发微针 (MN) 贴片,但通常仅限于提供亚毫克剂量。这是因为较大的贴片可能更难以应用于皮肤,而人类受试者对较大的 MN 贴片的接受程度的研究有限。在这里,我们通过激光微加工制造了 18 种不同的大型 MN 贴片设计,具有不同的 MN 长度(800-1500 μm)、MN 数量(每个贴片 225 到 900 MN)、MN 之间的空间(600-1100 μm)和 MN 基底直径(200–250 微米)。在将这些贴剂手动应用于人类参与者后,我们评估了剂量递送效率、递送的总剂量、每 MN 递送的剂量、MN 穿透深度和整个 MN 递送效率。我们发现所有这些参数通常随着 MN 长度的减少而增加,MN 数量增加(其中长度≤1000 μm)并增加 MN-MN 间距。所有 MN 贴片设计引起的疼痛都比针刺感要小,研究参与者普遍认为是可以接受的。MN 贴片在皮肤上引起轻度或有时中度的暂时性红斑。与传统选择相比,研究参与者对长效避孕贴剂显示出更高的偏好,表明本研究中对 MN 贴剂的强烈兴趣和可接受性。

更新日期:2021-10-10
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