In recent years, microneedles (MNs) have gained considerable interest in drug formulation due to their non-invasive and patient-friendly nature. Dissolving MNs have emerged as a promising approach to enhance drug delivery across the skin in a painless manner without generating sharp waste and providing the possibility for self-administration. Cyclodextrins, a group of cyclic oligosaccharides, are well-established in pharmaceutical products due to their safety and unique ability to form inclusion complexes with various drug molecules. In this manuscript, we report the development and characterization of dissolving MNs composed of cyclodextrins for intradermal delivery of a cyclodextrin-based nanoparticulate vaccine. Different cyclodextrins were tested and the most promising candidates were fabricated into MNs by micromolding. The MNs' piercing effectiveness and drug permeation across the skin were tested . Furthermore, studies were carried out to assess the skin's tolerance to cyclodextrin-based MNs, and to evaluate the immune response using a model peptide antigen in a mouse model. The data revealed that the MNs were well-tolerated and effective, even leading to dose-sparing effects. This study highlights the potential of cyclodextrin-based dissolving MNs as a versatile platform for intradermal vaccine delivery, providing a compatible matrix for nanoparticulate formulations to enhance immune responses.

中文翻译：

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用于递送基于纳米颗粒的肽抗原疫苗的环糊精微针

近年来，微针（MN）因其非侵入性和对患者友好的性质而在药物制剂领域引起了极大的兴趣。溶解微纳米粒子已成为一种有前途的方法，可以以无痛的方式增强药物在皮肤上的输送，不会产生尖锐的废物，并提供自我给药的可能性。环糊精是一组环状低聚糖，由于其安全性以及与各种药物分子形成包合物的独特能力，在医药产品中得到了广泛应用。在这篇手稿中，我们报告了由环糊精组成的溶解性微球的开发和表征，用于皮内递送基于环糊精的纳米颗粒疫苗。我们测试了不同的环糊精，并通过微成型将最有希望的候选环糊精制造成 MN。测试了 MN 的穿刺效果和药物在皮肤上的渗透性。此外，还进行了研究以评估皮肤对基于环糊精的 MN 的耐受性，并在小鼠模型中使用模型肽抗原评估免疫反应。数据显示，MN 具有良好的耐受性和有效性，甚至可以产生剂量节约效应。这项研究强调了基于环糊精的可溶性微球作为皮内疫苗递送的多功能平台的潜力，为纳米颗粒制剂提供兼容的基质以增强免疫反应。