School of Chemical Engineering, University of Birmingham, Edgbaston, Birmingham B15 2TT, UK.
School of Chemical Engineering, University of Birmingham, Edgbaston, Birmingham B15 2TT, UK; Biopharmaceutics, Pharmaceutical Development, PDS, MST, RD Platform Technology & Science, GSK, David Jack Centre, Park Road, Ware, Hertfordshire SG12 0DP, UK.
Adv Drug Deliv Rev. 2021 Nov;178:113924. doi: 10.1016/j.addr.2021.113924. Epub 2021 Aug 12.
Orally ingestible medical devices offer significant opportunity in the diagnosis and treatment of gastrointestinal conditions. Their development necessitates the use of models that simulate the gastrointestinal environment on both a macro and micro scale. An evolution in scientific technology has enabled a wide range of in vitro, ex vivo and in vivo models to be developed that replicate the gastrointestinal tract. This review describes the landscape of the existing range of in vitro tools that are available to characterize ingestible devices. Models are presented with details on their benefits and limitations with regards to the evaluation of ingestible devices and examples of their use in the evaluation of such devices is presented where available. The multitude of models available provides a suite of tools that can be used in the evaluation of ingestible devices that should be selected on the functionality of the device and the mechanism of its function.
口服医疗器械在胃肠道疾病的诊断和治疗方面提供了巨大的机会。它们的开发需要使用模拟宏观和微观胃肠道环境的模型。科学技术的发展使得能够开发出广泛的体外、离体和体内模型来复制胃肠道。本文综述了现有的可用于表征口服器械的各种体外工具。介绍了这些模型的优缺点，以及它们在评价口服器械方面的应用实例，只要有可用的实例就会展示。现有的多种模型提供了一套可用于评价口服器械的工具，应根据器械的功能和作用机制来选择。
