Osaka University, Graduate School of Pharmaceutical Sciences, Laboratory of Biotechnology and Therapeutics, 1-6 Yamadaoka, Suita, Osaka 565-0871, Japan.
Expert Opin Drug Deliv. 2013 Apr;10(4):485-98. doi: 10.1517/17425247.2013.760542. Epub 2013 Jan 15.
Vaccination, which is the major fundamental prophylaxis against illness and death from infectious disease, has greatly contributed to the global improvement of human health. However, the disadvantages of conventional injection systems hamper the delivery of vaccination technologies to developing countries. The imminent practice of easy-to-use vaccination methods is expected to overcome certain issues associated with injectable vaccinations. One innovative method is the transcutaneous immunization (TCI) system.
Two major strategies for TCI are discussed in this review. One is to promote antigen permeation of the skin barrier by patch systems or nanoparticles. The other is the delivery of antigens into the skin by electroporation and microneedles in order to physically overcome the skin barrier. Moreover, adjuvant development for TCI is discussed.
Many different approaches have been developed for TCI, which have the potential to be effective, easy-to-use and painless methods of vaccination. However, in practical terms, the guidelines concerning the manufacturing processes and clinical trial evaluation of the procedures have not kept pace with the development of these novel formulations. The accumulation of information regarding skin characteristics and the properties of TCI devices will help refine TCI system development guidelines and thus lead to the improvement of transcutaneous vaccination.
疫苗接种是预防传染病导致疾病和死亡的主要基本措施,为全球人类健康的改善做出了巨大贡献。然而,传统注射系统的缺点阻碍了疫苗接种技术在发展中国家的推广。即将采用的易用型疫苗接种方法有望克服与可注射疫苗相关的某些问题。一种创新方法是经皮免疫(TCI)系统。
本文综述了 TCI 的两种主要策略。一种是通过贴剂系统或纳米颗粒促进抗原穿透皮肤屏障。另一种是通过电穿孔和微针将抗原递送入皮肤,从而物理克服皮肤屏障。此外,还讨论了 TCI 的佐剂开发。
已经开发出许多不同的 TCI 方法,这些方法具有成为有效、易用和无痛的疫苗接种方法的潜力。然而,在实践中,关于这些新型制剂制造过程和临床试验评估的指南并没有跟上这些新配方的发展步伐。关于皮肤特征和 TCI 设备性能的信息的积累将有助于完善 TCI 系统开发指南,从而促进经皮疫苗接种的改进。