Microneedle characterisation: the need for universal acceptance criteria and GMP specifications when moving towards commercialisation
Microneedle characterisation: the need for universal acceptance criteria and GMP specifications when moving towards commercialisation
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DOI：
10.1007/s13346-015-0237-z
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发表时间：
2015-08-01
影响因子：
5.4
通讯作者：
Donnelly, Ryan F.
中科院分区：
文献类型：
--
作者：
Lutton, Rebecca E. M.;Moore, Jessica;Donnelly, Ryan F.
自20世纪90年代末以来，人们对微针作为一种新型药物透皮给药系统的兴趣迅速增加（Margetts and Sawyer Contin Educ Anaesthesia Crit Care Pain. 7(5):171- 76,2007），各种不同设计和尺寸的微针系统已经被制造出来。然而，市面上的微针产品仍然很少。关于工业规模微针生产的一个主要问题是在良好生产规范（GMP）的背景下缺乏这种新剂型的具体质量标准。微针系统的研究人员使用一系列机械特性测试和微针插入分析技术来评估其各种设计的安全性和性能概况。由于缺乏用于证明微针机械性能和插入能力的标准化测试和设备，因此很难直接比较候选系统的使用性能。这篇综述强调了各种小组用来表征微针的机械测试和插入分析技术。这反过来又暴露了迫切需要在微针系统范围内保持一致性，以促进微针产品的创新和成功商业化。
With interest in microneedles as a novel drug transdermal delivery system increasing rapidly since the late 1990s (Margetts and Sawyer Contin Educ Anaesthesia Crit Care Pain. 7(5):171-76, 2007), a diverse range of microneedle systems have been fabricated with varying designs and dimensions. However, there are still very few commercially available microneedle products. One major issue regarding microneedle manufacture on an industrial scale is the lack of specific quality standards for this novel dosage form in the context of Good Manufacturing Practice (GMP). A range of mechanical characterisation tests and microneedle insertion analysis techniques are used by researchers working on microneedle systems to assess the safety and performance profiles of their various designs. The lack of standardised tests and equipment used to demonstrate microneedle mechanical properties and insertion capability makes it difficult to directly compare the in use performance of candidate systems. This review highlights the mechanical tests and insertion analytical techniques used by various groups to characterise microneedles. This in turn exposes the urgent need for consistency across the range of microneedle systems in order to promote innovation and the successful commercialisation of microneedle products.