Rouaz Khadija, Chiclana-Rodríguez Blanca, Nardi-Ricart Anna, Suñé-Pou Marc, Mercadé-Frutos Dèbora, Suñé-Negre Josep María, Pérez-Lozano Pilar, García-Montoya Encarna
Department of Pharmacy and Pharmaceutical Technology and Physical Chemistry, Faculty of Pharmacy and Food Sciences, University of Barcelona, Av. Joan XXIII, 27-31, 08028 Barcelona, Spain.
Pharmacotherapy, Pharmacogenetics and Pharmaceutical Technology Research Group Bellvitge Biomedical Research Institute (IDIBELL), Av. Gran via de l'Hospitalet, 199-203, 08090 Barcelona, Spain.
Pharmaceutics. 2021 Mar 13;13(3):387. doi: 10.3390/pharmaceutics13030387.
This theoretical study seeks to critically review the use of excipients in the paediatric population. This study is based on the rules and recommendations of European and American drug regulatory agencies. On the one hand, this review describes the most frequent excipients used in paediatric medicine formulations, identifying the compounds that scientific literature has marked as potentially harmful regarding the side effects generated after exposure. On the other hand, this review also highlights the importance of carrying out safety -checks on the excipients, which, in most cases, are linked to toxicity studies. An excipient in the compilation of paediatric population databases is expected to target safety and toxicity, as in the STEP database. Finally, a promising pharmaceutical form for child population, ODT (Orally Disintegrating Tablets), will be studied.
本理论研究旨在批判性地审视辅料在儿科人群中的使用情况。本研究基于欧美药品监管机构的规则和建议。一方面，本综述描述了儿科药物制剂中最常用的辅料，确定了科学文献中标记为在接触后产生的副作用方面具有潜在危害的化合物。另一方面，本综述还强调了对辅料进行安全性检查的重要性，在大多数情况下，这与毒性研究相关。正如STEP数据库那样，预计在儿科人群数据库的编制中，一种辅料将以安全性和毒性为目标。最后，将研究一种适用于儿童群体的有前景的剂型——口腔崩解片（ODT）。
