Oral drug delivery strategies for development of poorly water soluble drugs in paediatric patient population

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 methodolo-gies 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 for-mulating 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 chal-lenges posed by these strategies and adaptations of the adult approach/product presentation required to enable paediatric drug development and administration.(c) 2022 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Automated summary

Selecting the appropriate formulation and solubility-enabling technology is crucial for developing formulations for paediatric patients. However, there is a lack of literature in this area, and the need for flexible dosing and adaptations for paediatric subjects pose challenges. An efficient and systematic approach is required to select the best drug delivery system that considers the drug's properties and patient requirements.