School of Pharmacy, Queen's University Belfast, Belfast, UK.
Department of Pharmaceutical Sciences and Technology, Institute of Chemical Technology, Nathalal Parekh Marg Matunga, Mumbai, Maharashtra, India.
Handb Exp Pharmacol. 2024;284:93-111. doi: 10.1007/164_2023_653.
In the last 20 years, protein, peptide and nucleic acid-based therapies have become the fastest growing sector in the pharmaceutical industry and play a vital role in disease therapy. However, the intrinsic sensitivity and large molecular sizes of biotherapeutics limit the available routes of administration. Currently, the main administration routes of biomacromolecules, such as parenteral, oral, pulmonary, nasal, rectal and buccal routes, each have their limitations. Several non-invasive strategies have been proposed to overcome these challenges. Researchers were particularly interested in microneedles (MNs) and polymeric films because of their less invasiveness, convenience and greater potential to preserve the bioactivity of biotherapeutics. By facilitating with MNs and polymeric films, biomacromolecules could provide significant benefits to patients suffering from various diseases such as cancer, diabetes, infectious and ocular diseases. However, before these devices can be used on patients, how to upscale MN manufacture in a cost-effective and timely manner, as well as the long-term safety of MN and polymeric film applications necessitates further investigation.
在过去的 20 年中,基于蛋白质、肽和核酸的疗法已成为制药行业增长最快的领域,在疾病治疗中发挥着至关重要的作用。然而,生物治疗剂的固有敏感性和较大的分子尺寸限制了可用的给药途径。目前,生物大分子的主要给药途径,如注射、口服、肺部、鼻腔、直肠和口腔途径,各有其局限性。已经提出了几种非侵入性策略来克服这些挑战。由于微针(MNs)和聚合物膜的侵入性较小、方便且更有可能保持生物治疗剂的生物活性,研究人员对其特别感兴趣。通过促进 MNs 和聚合物膜的使用,生物大分子可以为患有各种疾病(如癌症、糖尿病、传染病和眼部疾病)的患者带来显著的益处。然而,在这些装置可以用于患者之前,需要进一步研究如何以具有成本效益和及时的方式扩大 MN 的制造规模,以及 MN 和聚合物膜应用的长期安全性。