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Safety Evaluation of Solid Polymer Microneedles in Human Volunteers at Different Application Sites

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单位: [1]Beijing Laboratory of Biomedical Materials, College of Materials Science and Engineering, Beijing University of Chemical Technology, Beijing 100029, People’s Republic of China [2]Department of Dermatology, China-Japan Friendship Hospital, East Street Cherry Park, Chaoyang District, Beijing 100029, People’s Republic of China
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关键词: solid microneedles human study pretreatment pain skin irritation

摘要:
The focus of solid microneedles technology to date has largely been on cosmetology, vaccination, and insulin delivery, etc. However, limited information is available about the safety of solid polymer microneedles applied in different parts of the human body. In consideration of the different application sites of cosmetology, vaccination, and insulin delivery involved with microneedles technique, factors influencing user acceptance to microneedles including the length and density as well as the size of microneedle patches were systematically investigated by applying different microneedle patches on the forehead, forearm, and abdomen skins of 18 healthy human participants. Multiple insertion tests demonstrated that solid microneedles with a length of 400 mu m, a density of 100 MN/cm(2), and an array size of 10 x 10 were optimal for forehead pretreatment. Microneedles with lengths of 400 and 600 mu m, densities of 49 and 100 MN/cm(2), and an array size of 10 x 10 caused less pain and slight skin irritation in the forearm, whereas 400 mu m height, 49 and 100 MNs/cm(2) densities, and 5 x 5, 10 x 10, and 10 x 20 arrays of the solid microneedles were not considered painful and were well-tolerated in abdomen insertion. In conclusion, the optimization of the dimensions of microneedles according to application sites could improve medication compliance and the safety of clinical use of solid microneedles.

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最新[2025]版:
大类 | 3 区 材料科学
小类 | 4 区 材料科学:生物材料 4 区 纳米科技
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Q2 MATERIALS SCIENCE, BIOMATERIALS Q2 NANOSCIENCE & NANOTECHNOLOGY

影响因子: 最新[2023版] 最新五年平均[2021-2025] 出版当年[2017版] 出版当年五年平均[2013-2017] 出版前一年[2016版]

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第一作者单位: [1]Beijing Laboratory of Biomedical Materials, College of Materials Science and Engineering, Beijing University of Chemical Technology, Beijing 100029, People’s Republic of China
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