European Paediatric Formulation Initiative (EUPFI), University College London School of Pharmacy, London WC1N 1AX, UK.
School of Pharmacy and Biomolecular Sciences, RCSI University of Medicine and Health Sciences, Dublin 2, Ireland.
Adv Drug Deliv Rev. 2022 Nov;190:114507. doi: 10.1016/j.addr.2022.114507. Epub 2022 Aug 29.
Selecting the appropriate formulation and solubility-enabling technology for poorly water soluble drugs is an essential element in the development of formulations for paediatric patients. Different methodologies and structured strategies are available to select a suitable approach and guide formulation scientists for development of adult formulations. However, there is paucity of available literature for selection of technology and overcoming the challenges in paediatric formulation development. The need for flexible dosing, and the limited knowledge of the safety of many formulation excipients in paediatric subjects, impose significant constraints and in some instances require adaptation of the approaches taken to formulating these drugs for the adult population. Selection of the best drug delivery system for paediatrics requires an efficient, systematic approach that considers a drug's physical and chemical properties and the targeted patient population's requirements. This review is a step towards development of a strategy for the design of solubility enhancing paediatric formulations of highly insoluble drugs. The aim of this review is to provide an overview of different approaches and strategies to consider in order to assist development of paediatric formulation for poorly water-soluble drugs with the provision of examples of some marketed products. In addition, it provides recommendations to overcome the range of challenges posed by these strategies and adaptations of the adult approach/product presentation required to enable paediatric drug development and administration.
为儿童患者开发制剂时，选择合适的制剂和溶出增强技术是至关重要的。有不同的方法和结构化策略可用于选择合适的方法，并为开发成人制剂的制剂科学家提供指导。然而，在选择技术和克服儿科制剂开发中的挑战方面，相关文献却很少。需要灵活的给药剂量，以及对许多儿科受试者中制剂辅料的安全性的了解有限，这对儿科制剂开发构成了重大限制，在某些情况下，需要对为成年人群体开发这些药物的方法进行调整。选择最适合儿科的药物输送系统需要一种高效、系统的方法，该方法需要考虑药物的物理和化学性质以及目标患者群体的需求。本综述旨在制定一种策略，用于设计高难溶性药物的增溶儿科制剂。本综述的目的是概述为开发儿童用制剂时需要考虑的不同方法和策略，并提供一些已上市产品的实例。此外，它还提供了克服这些策略带来的一系列挑战的建议，以及对成人方法/产品剂型的调整，以促进儿科药物的开发和管理。
