非处方鼻内给药中的人因与器械工程：GentleMist Technology™

文献信息

中文摘要

鼻内给药具有无创、起效迅速且适合自我给药的特点，然而鼻喷雾剂的实际性能取决于制剂、器械力学、鼻腔解剖结构与使用者技术之间的相互作用，而非仅取决于活性成分本身。本叙述性综述以GentleMist Technology™作为新兴以器械为中心开发的代表性实例，探讨气溶胶科学、区域靶向与人因如何共同塑造鼻内给药性能。计算流体动力学（CFD）与基于解剖学的体外模型表明，器械几何形状、羽流特征与给药角度可显著改变剂量沉积位置，而人因研究则确定预充、定位与角度是成功实现非处方（OTC）使用的关键决定因素。我们总结了早期可行性数据，提示角度优化给药可能增加后鼻咽部递送，且基本操作任务对非专业使用者可行，其中预充成为特定的可用性薄弱环节。我们还综述了基于马来酸氯苯那敏（CPM）的鼻内制剂在过敏性鼻炎与病毒性上呼吸道疾病中的初步临床证据。尽管最强的器械特异性发现仍属初步且需独立重复验证，但它们支持从以制剂为中心的模式向器械-制剂-使用者整合范式的新兴转变。

英文摘要

Intranasal drug delivery is noninvasive, rapid-acting, and well suited to self-administration, yet the real-world performance of nasal sprays depends on the interaction among formulation, device mechanics, nasal anatomy, and user technique rather than on the active ingredient alone. This narrative review examines how aerosol science, regional targeting, and human factors jointly shape intranasal performance, using GentleMist Technology™ as a representative example of emerging device-centered development. Computational fluid dynamics (CFD) and anatomically informed in vitro models indicate that device geometry, plume characteristics, and administration angle can significantly alter where a dose is deposited, while human factors research identifies priming, positioning, and angulation as key determinants of successful over-the-counter (OTC) use. We summarize early feasibility data suggesting that angle-optimized administration may increase posterior nasopharyngeal delivery and that essential tasks are feasible for lay users, with priming emerging as a specific usability vulnerability. We also review preliminary clinical evidence on a chlorpheniramine maleate (CPM)-based intranasal formulation in allergic rhinitis and viral upper respiratory illness. Although the strongest device-specific findings remain preliminary and require independent replication, they support an emerging shift from a formulation-centered model toward an integrated device-formulation-user paradigm.