Department of Pharmacy and Pharmacology, University of Bath, Claverton Down, Bath, BA2 7AY, UK.
Pharmaceutical Technology and Development, Astra Zeneca, Macclesfield, UK.
AAPS J. 2020 Mar 4;22(2):54. doi: 10.1208/s12248-020-0432-9.
Medicine co-administration with food or drink vehicles is a common administration practice in paediatrics. The aims of this review were (i) to describe the current recommended strategies for co-administration of paediatric medicines with food and drinks (vehicles); (ii) to compare current administration recommendations from different countries; and (iii) to obtain a global perspective on the rationale behind the choice of recommended vehicle, in the context of the physicochemical properties of the drug and formulation. This study used a defined search strategy on the practices of paediatric medicine co-administration with vehicles, recommended in a commonly used paediatric and neonatal handbook, in addition to the information previously gathered from UK formularies. Logistic regression analysis was performed to further understand the biopharmaceutical basis of the choice of recommended vehicle for medicine co-administration. Differences were identified in the type of vehicles globally recommended for medicine co-administration. Ultimately, a statistical model was developed which provided an understanding on which vehicle is recommended for use with drugs/formulations, with basis on their biopharmaceutical properties. Overall, this review highlights the areas where further information is needed to support standardised procedures and guide the recommendation of age-appropriate and acceptable vehicles for use in the co-administration of paediatric medicines. Unified requirements are needed for harmonisation of the practice of medicine co-administration with vehicles. In vitro and/or in silico tools should be developed to evaluate the potential clinical outcomes of this practice during paediatric drug development.
将药物与食物或饮料载体共同给药是儿科中的常见给药方法。本综述的目的是:(i) 描述目前推荐的儿科药物与食物和饮料(载体)共同给药的策略;(ii) 比较不同国家的现行给药建议;以及 (iii) 在药物和制剂的理化性质背景下,从全球角度了解推荐载体选择背后的原理。本研究使用了一种定义明确的搜索策略,针对常用儿科和新生儿手册中推荐的儿科药物与载体共同给药的实践,以及之前从英国处方集收集的信息。进行了逻辑回归分析,以进一步了解药物共同给药时推荐载体选择的生物制药基础。在全球范围内,推荐用于药物共同给药的载体类型存在差异。最终,开发了一个统计模型,该模型基于药物/制剂的生物制药特性,了解了推荐使用哪种载体与药物共同给药。总的来说,本综述强调了需要进一步信息的领域,以支持标准化程序并指导推荐适合儿科药物共同给药的年龄适宜和可接受的载体。需要统一的要求来协调药物与载体共同给药的实践。应开发体外和/或计算工具,以在儿科药物开发期间评估这种给药实践的潜在临床结果。