Microneedles for Transdermal Drug Delivery
Microneedles for Transdermal Drug Delivery
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DOI：
10.1002/9783527814633.ch10
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发表时间：
2019-11
期刊：
影响因子：
--
通讯作者：
Eman M. Migdadi;R. Donnelly
中科院分区：
文献类型：
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作者：
Eman M. Migdadi;R. Donnelly
经皮药物递送包括将药物施加到皮肤以产生全身效应。然而，相对较少的药物具有被动穿过皮肤皮层屏障的必要特性。微针（MN）技术是一种新型药物递送技术，其通过在皮肤内产生微孔来增加皮肤渗透性，药物通过所述微孔被动扩散至真皮微循环。这克服了有效药物渗透的障碍。具有不同策略的MN在体外、离体和体内均显示出增强具有不同理化性质的药物和生物分子的透皮递送的能力。随着MN产品的大规模生产、商业化以及最终患者使用，有几个优先事项必须得到解决。评价最终用户的意见和最终MN产品的期望是确保适当MN补片设计的重要步骤。这必须符合产品安全性和有效性方面的监管要求。此外，现在迫切需要可以转化为大规模生产的合适的制造方法，以将该技术从小规模实验室制造推向商业规模。MN技术有效性的证据已得到广泛证实，特别是在不同的动物模型和几个小型临床试验中。随着必要的制造技术的进步，需要进行广泛的临床试验。预计第一批MN产品将基于疫苗和小的亲水性药物化合物或MN诊断装置的递送，因为迄今为止，这些已经被最广泛地研究。
Transdermal drug delivery includes application of drug(s) to the skin for systemic effects. However, relatively few drugs possess the requisite characteristics to passively traverse the skin'sstratum corneumbarrier. Microneedle (MN) technology is a novel drug delivery technology that increases skin permeability by creating microscopic pores within the skin through which the passive drug diffusion to the dermal microcirculation occurs. This overcomes the barrier to efficient drug permeation. MNs, with different strategies, have shown the ability to enhance transdermal delivery of drugs and biomolecules with different physicochemical propertiesin vitro,ex vivo, andin vivo. Progressing toward large‐scale manufacture, commercialization, and, ultimately, patient use of a MN product, there are several priorities that must be addressed. Evaluation of end user opinion and expectations of a final MN product is an essential step to ensure appropriate MN‐patch design. This must be coincided with meeting regulatory requirements in terms of product safety and efficacy. Moreover, suitable manufacturing methods that can be translated to large‐scale production are now urgently needed to advance the technology from small‐scale laboratory fabrication to commercial scale. Evidence of MN technology efficacy has been widely demonstrated, particularly in different animal models and several small clinical trials. As the necessary manufacturing advancements are made, extensive clinical trials need to be conducted. It is expected that the first MN products will be based on the delivery of vaccines and small, hydrophilic drug compounds or a MN diagnostic device as, to date, these have been most extensively studied.