Successful application of large microneedle patches by human volunteers.
Successful application of large microneedle patches by human volunteers.
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DOI：
10.1016/j.ijpharm.2017.02.011
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发表时间：
2017-04-15
影响因子：
5.8
通讯作者：
Donnelly RF
中科院分区：
文献类型：
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作者：
Ripolin A;Quinn J;Larrañeta E;Vicente-Perez EM;Barry J;Donnelly RF
我们首次描述了大型微针贴片的设计、生产和评价。这些系统基于16个单独的微针阵列(针高600g/μm)，由15%w/w Gantrez®S97和7.5%w/w聚乙二醇10000Da的水混合物制成。FTIR证实了酯基交联剂的存在，且机械强度良好。在一个经过验证的皮肤模型中，插入深度约为500xμm。10名人类志愿者在适当的指导下，成功地将这些较大贴片的微针插入他们的皮肤，并通过皮肤水分损失测量证实了这一点。在大斑块的面积上，平均插入深度在300~450μm之间。这与同一志愿者自行应用的单个单位MN贴片没有显著差异，这是令人鼓舞的。如果要将这项技术成功地转化到临床上用于药物递送，将需要比1-2平方厘米大得多的微针贴片。这里描述的工作表明，患者可以成功地使用这种较大的贴片，潜在地为显著扩大经皮给药的市场规模打开了可能性。
We describe, for the first time, the design, production and evaluation of large microneedle patches. Such systems, based on 16 individual microneedle arrays (needle height 600 μm), were prepared from aqueous blends of 15% w/w Gantrez® S97 and 7.5% w/w poly(ethyleneglycol) 10,000 Da. Ester-based crosslinking was confirmed by FTIR and mechanical strength was good. Insertion depths in a validated skin model were approximately 500 μm. Ten human volunteers successfully self-inserted the microneedles of these larger patches in their skin, following appropriate instruction, as confirmed by transepidermal water loss measurements. The mean insertion depth ranged between 300 and 450 μm over the area of the large patches. That this was not significantly different to a single unit MN patch self-applied by the same volunteers is encouraging. Microneedle patch sizes much larger than the 1–2 cm2 will be required if this technology is to be successfully translated to clinic for delivery of drug substances. The work described here suggests that use of such larger patches by patients can be successful, potentially opening up the possibility for a significant expansion of the size of the market for transdermal drug delivery.