Assessing the risk of a clinically significant infection from a Microneedle Array Patch (MAP) product

作者：Maria Dul, Mohammed Alali, Mahmoud Ameri, Matthew Douglas Burke, Christine M. Craig, Benjamin Paul Creelman, Lisa Dick, Ryan F. Donnelly, Michael N. Eakins, Collrane Frivold, Angus Harry Forster, Philippe‐Alexandre Gilbert, Stefan Henke, Sébastien Henry, Desmond G. Hunt, Hayley Lewis, Howard I. Maïbach, Jessica Joyce Mistilis, Jung‐Hwan Park, Mark R. Prausnitz, David Kenneth Robinson, Carmen Amelia Rodriguez Hernandez, Charles Warren Ross, Juyeop Shin, Tycho Joseph Speaker, Kevin Taylor, Darin Zehrung, James C. Birchall, Courtney Jarrahian, Siôn A. Coulman · 发表于：Journal of Controlled Release · 年份：2023 · DOI：10.1016/j.jconrel.2023.07.001 · 被引用次数：38 · 研究领域：Advancements in Transdermal Drug Delivery、Dermatology and Skin Diseases、Essential Oils and Antimicrobial Activity

Microneedle Array Patches (MAPs) are an emerging dosage form that creates transient micron-sized disruptions in the outermost physical skin barrier, the stratum corneum, to facilitate delivery of active pharmaceutical ingredients to the underlying tissue. Numerous MAP products are proposed and there is significant clinical potential in priority areas such as vaccination. However, since their inception scientists have hypothesized about the risk of a clinically significant MAP-induced infection. Safety data from two major Phase 3 clinical trials involving hundreds of participants, who in total received tens of thousands of MAP applications, does not identify any clinically significant infections. However, the incumbent data set is not extensive enough to make definitive generalizable conclusions. A comprehensive assessment of the infection risk is therefore advised for MAP products, and this should be informed by clinical and pre-clinical data, theoretical analysis and informed opinions. In this article, a group of key stakeholders identify some of the key product- and patient-specific factors that may contribute to the risk of infection from a MAP product and provide expert opinions in the context of guidance from regulatory authorities. Considerations that are particularly pertinent to the MAP dosage form include the specifications of the finished product (e.g. microbial specification), it's design features, the setting for administration, the skill of the administrator, the...