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微针贴片设计以增加给予人体受试者的剂量。

Microneedle patch designs to increase dose administered to human subjects.

机构信息

School of Chemical and Biomolecular Engineering, Georgia Institute of Technology, Atlanta, GA, USA; School of Pharmaceutical Sciences, Wuhan University, Wuhan, Hubei Province, China.

School of Chemical and Biomolecular Engineering, Georgia Institute of Technology, Atlanta, GA, USA.

出版信息

J Control Release. 2021 Nov 10;339:350-360. doi: 10.1016/j.jconrel.2021.09.036. Epub 2021 Sep 29.


DOI:10.1016/j.jconrel.2021.09.036
PMID:34597745
Abstract

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.

摘要

微针 (MN) 贴片正在被开发用于许多不同种类的药物,但通常仅限于传递亚毫克剂量。这是因为较大的贴片可能更难以应用于皮肤,并且较大的 MN 贴片的可接受性已经受到了有限的研究。在这里,我们通过激光微加工制造了 18 种不同的大 MN 贴片设计,其 MN 长度(800-1500 μm)、MN 数量(每个贴片 225 到 900 个 MN)、MN 之间的间距(600-1100 μm)和 MN 基底直径(200-250 μm)不同。在手动将这些贴片应用于人体参与者后,我们评估了剂量传递效率、总传递剂量、每个 MN 的传递剂量、MN 穿透深度和整个 MN 传递效率。我们发现,所有这些参数通常随着 MN 长度的减小、MN 数量的增加(在 ≤1000 μm 长度范围内)和 MN-MN 间距的增加而增加。所有 MN 贴片设计引起的疼痛均小于刺痛感,并且通常被研究参与者认为是可接受的。MN 贴片在皮肤引起轻度,有时是中度的短暂红斑。研究参与者对 MN 贴片在长效避孕方面的偏好高于传统选择,这表明 MN 贴片在这项研究中具有强烈的兴趣和可接受性。

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