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Review of paediatric gastrointestinal physiology relevant to the absorption of orally administered medicines
Advanced Drug Delivery Reviews ( IF 15.2 ) Pub Date : 2021-12-17 , DOI: 10.1016/j.addr.2021.114084
Erik Wollmer 1 , Anna-Lena Ungell 2 , Jean-Marie Nicolas 3 , Sandra Klein 1
Affiliation  

Despite much progress in regulations to improve paediatric drug development, there remains a significant need to develop better medications for children. For the design of oral dosage forms, a detailed understanding of the specific gastrointestinal (GI) conditions in children of different age categories and how they differ from GI conditions in adults is essential. Several review articles have been published addressing the ontogeny of GI characteristics, including luminal conditions in the GI tract of children. However, the data reported in most of these reviews are of limited quality because (1) information was cited from very old publications and sometimes low quality sources, (2) data gaps in the original data were filled with textbook knowledge, (3) data obtained on healthy and sick children were mixed, (4) average data obtained on groups of patients were mixed with data obtained on individual patients, and (5) results obtained using investigative techniques that may have altered the outcome of the respective studies were considered. Consequently, many of these reviews draw conclusions that may be incorrect. The aim of the present review was to provide a comprehensive and updated overview of the available original data on the ontogeny of GI luminal conditions relevant to oral drug absorption in the paediatric population. To this end, the PubMed and Web of Science metadatabases were searched for appropriate studies that examined age-related conditions in the oral cavity, esophagus, stomach, small intestine, and colon. Maturation was observed for several GI parameters, and corresponding data sets were identified for each paediatric age group. However, it also became clear that the ontogeny of several GI traits in the paediatric population is not yet known. The review article provides a robust and valuable data set for the development of paediatric in vitro and in silico biopharmaceutical tools to support the development of age-appropriate dosage forms. In addition, it provides important information on existing data gaps and should provide impetus for further systematic and well-designed in vivo studies on GI physiology in children of specific age groups in order to close existing knowledge gaps and to sustainably improve oral drug therapy in children.



中文翻译:

与口服药物吸收相关的小儿胃肠生理学综述

尽管在改善儿科药物开发的法规方面取得了很大进展,但仍然非常需要为儿童开发更好的药物。对于口服剂型的设计,必须详细了解不同年龄段儿童的特定胃肠道 (GI) 状况以及它们与成人胃肠道状况的区别。已经发表了几篇关于胃肠道特征的个体发育的评论文章,包括儿童胃肠道的管腔状况。然而,大多数这些评论中报告的数据质量有限,因为(1)信息来自非常古老的出版物,有时是低质量的来源,(2)原始数据中的数据空白由教科书知识填补,(3)数据在健康和生病的孩子身上获得的结果是混合的,(4) 将在患者组中获得的平均数据与从个体患者中获得的数据混合在一起,并且 (5) 考虑使用可能改变了各自研究结果的调查技术获得的结果。因此,许多这些评论得出的结论可能不正确。本综述的目的是对儿科人群中与口服药物吸收相关的胃肠道腔内疾病个体发育的可用原始数据提供全面和更新的概述。为此,在 PubMed 和 Web of Science 元数据库中搜索了适当的研究,这些研究检查了口腔、食道、胃、小肠和结肠中与年龄相关的状况。观察到几个 GI 参数的成熟度,并为每个儿科年龄组确定了相应的数据集。然而,同样清楚的是,儿科人群中几种胃肠道特征的个体发育尚不清楚。这篇评论文章为儿科的发展提供了一个强大而有价值的数据集体外计算机生物制药工具,以支持开发适合年龄的剂型。此外,它提供了有关现有数据差距的重要信息,并应为进一步系统和精心设计的特定年龄组儿童胃肠道生理学体内研究提供动力,以弥合现有知识差距并可持续改善儿童口服药物治疗.

更新日期:2021-12-17
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