超越针头：以微针给药系统变革传统医疗

文献信息

中文摘要

背景： 在当今时代，现代给药系统在确保药物系统性地进入体内并到达预期靶点方面发挥着基础性作用。近几十年来，给药系统已从简单的口服和注射制剂，演变为与多种已开发技术相互融合，从而构建出更安全、有效且患者依从性更好的创新治疗方法。纳米颗粒、微粒、脂质体、聚合物基系统、3D打印和生物载体等进步技术，已被广泛与特异性靶向给药技术相结合，应用于感染性、肿瘤性、肺部和神经系统疾病。微针透皮贴片也同步取得进展。它们因能够超越角质层、微创性、独立给药和患者依从性而受到关注。本综述提供转化视角，将微针材料与器械工程同给药性能、患者可用性、临床证据、生产可扩展性和监管考量相结合，以考察微针技术从实验室开发走向真实世界医疗实施的进展。微针被制成不同类型，如固体、涂层、空心、溶解性和水凝胶基微针，以提高给药精度、改善渗透性并适用于多样人群；同时设计用于复杂分子，如蛋白质、肽类、激素、疫苗和美容制剂。此外，研究表明微针被老年和儿科群体广泛接受，可减轻焦虑，并对恐针症个体、口服剂量吞咽困难者以及静脉功能受损者显著有益，此外还有助于打破社会不平等。微针诱导的微通道可短暂增加皮肤通透性，并可能根据微针几何形状、制剂、应用条件、皮肤部位和个体皮肤特征促进持续或受控给药。这些微通道的持续存在及其安全性特征取决于器械和制剂特性。微针是新型给药系统的关键组成部分，解决了传统给药引起的并发症，并被证明侧重于改善药代动力学参数、以患者为中心的治疗、靶向递送和真实世界可及性。微针技术的进一步变革可带来具有临床前景的给药系统，用于长期治疗管理并促进下一代疗法。

英文摘要

In the present era, modern drug delivery systems play a fundamental role in ensuring the systematic delivery of the drug into the body, reaching the desired targets. Across recent decades, the drug delivery system has evolved from simple oral and injectable formulations to interpolating with various developed techniques to fabricate innovative treatment approaches for safer, effective, and better patient compliance. Progressive techniques like nanoparticles, microparticles, liposomes, polymer-based systems, 3D printing, and biological carriers have been extensively combined with specifically targeted drug-delivery techniques across infectious, oncological, pulmonary, and neurological conditions. Microneedle transdermal patches have advanced in tandem. They have gained attention for their advancement to surpass the stratum corneum, minimal invasiveness, independent delivery, and patient compliance. This review provides a translational perspective by integrating MN materials and device engineering with drug-delivery performance, patient usability, clinical evidence, manufacturing scalability, and regulatory considerations to examine the progression of MN technologies from laboratory development toward real-world healthcare implementation. Microneedles are fabricated in different types, such as solid, coated, hollow, dissolving, and hydrogel-based, to enhance precision in dosing, better permeability, and suitability across diverse populations, and complex molecules are designed, such as proteins, peptides, hormones, vaccines, and cosmetic agents. Moreover, studies suggest MN are widely accepted by geriatric and pediatric groups, reduce anxiety, and significantly benefit individuals with trypanophobia, swallowing difficulties in the case of oral doses, and compromised venous action, in addition to breaking social inequity. MN-induced microchannels can transiently increase skin permeability and may facilitate sustained or controlled drug delivery depending on MN geometry, formulation, application conditions, skin site, and individual skin characteristics. The persistence of these microchannels and their safety profile are dependent on both device and formulation characteristics. MN is a pivotal part of the novel drug delivery system, addresses the complications arising due to conventional drug delivery, and proves to focus on the improvement of pharmacokinetic parameters, patient-centric therapy, target delivery, and real-world accessibility. Further transformation in the enhancement of MN technology can lead to clinically promising drug delivery systems for the management of long-term treatment and boost next-generation therapies.