Microneedle & film-forming gel transdermal delivery strategy: A novel approach for vaccine delivery

Tiancheng Xiong; Yang Han; Zhiyun Qi; Sha Guo; Xueyan Hu; Cui Wang; Lingkun Li; Tianyu Ma; Jingyi Chen; Jinghui Li; Jing Han; Hao Wu

doi:10.1016/j.ijpharm.2025.125905

Microneedle & film-forming gel transdermal delivery strategy: A novel approach for vaccine delivery

Int J Pharm. 2025 Jun 25:125905. doi: 10.1016/j.ijpharm.2025.125905. Online ahead of print.

Authors

Tiancheng Xiong¹, Yang Han², Zhiyun Qi³, Sha Guo⁴, Xueyan Hu¹, Cui Wang¹, Lingkun Li¹, Tianyu Ma⁵, Jingyi Chen¹, Jinghui Li¹, Jing Han⁶, Hao Wu⁷

Affiliations

¹ School of Pharmaceutical Engineering, Shenyang Pharmaceutical University, Liaoning, China.
² School of Traditional Chinese Medicine, Shenyang Pharmaceutical University, Liaoning, China.
³ School of Pharmaceutical Engineering, Shenyang Pharmaceutical University, Liaoning, China; WHO Collaborating Centre for Standardization and Evaluation of Biologicals, State Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, National Institutes for Food and Drug Control, Beijing, China.
⁴ WHO Collaborating Centre for Standardization and Evaluation of Biologicals, State Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, National Institutes for Food and Drug Control, Beijing, China.
⁵ School of Life Sciences and Biopharmaceutical Sciences, Shenyang Pharmaceutical University, Liaoning, China.
⁶ School of Functional Food and Wine, Shenyang Pharmaceutical University, Liaoning, China. Electronic address: 102040201@syphu.edu.cn.
⁷ School of Pharmaceutical Engineering, Shenyang Pharmaceutical University, Liaoning, China. Electronic address: haowu@syphu.edu.cn.

PMID: 40578458
DOI: 10.1016/j.ijpharm.2025.125905

Abstract

The COVID-19 pandemic has underscored the significant challenges of vaccine distribution, particularly to low- and middle-income countries. Even when vaccines are made available through purchases or donations, issues such as insufficient trained medical personnel and inadequate infrastructure impede their widespread use. To address these challenges, we propose the Microneedle & Film-Forming Gel Transdermal Delivery Strategy (MFT strategy), which combines the minimally invasive nature of microneedles with the stability of film-forming gels that can be stored at room temperature. This strategy aimed to simplify vaccine production, reduce logistical burdens, and improve the efficiency of transdermal vaccine delivery while generating strong immune responses. In this study, we used ovalbumin as a model antigen and developed microneedles from methacrylic acid-modified hyaluronic acid, polyvinylpyrrolidone, and polyvinyl alcohol, in conjunction with a polyvinyl alcohol-borax (PVA-B) film-forming gel. In vitro experiments demonstrated that the MFT strategy has achieved an efficiency improvement of 202.75 % compared to previously reported strategies. Besides, PVA-B film forming gel displayed strong antimicrobial properties and effectively stabilized proteins over 30 days at 25 °C, preserving the antigenic structure essential for vaccine efficacy. In vivo tests revealed that the MFT strategy induced humoral immune responses comparable to those achieved by intramuscular injection, with histological analysis confirming good skin tolerance and safety. Overall, the MFT strategy represents a promising vaccine delivery method with substantial clinical potential.

Keywords: Film forming gel; Hydrogel microneedles; Intradermal injection strategy; Micropore recovery; Transdermal drug delivery; Vaccine.