How can oral paediatric formulations be improved? A challenge for the XXI century

Abstract

Paediatric oral formulations need to be improved. This is an indisputable fact that has gain attention from the regulators, the medical staff, and researchers. The lack of adequate medicines developed for children, resulted in several off-label and unlicensed prescriptions, increasing the risks of adverse drug reactions. When formulating a paediatric medicine, it is necessary to consider the product acceptability determined by the characteristics of both product and user (Gerrard et al., 2019). In the last decades, the regulators have issued guidelines to facilitate the development of medicines specialized for children. The use of oral solid dosage forms instead of liquid dosage forms has been preferred due to advantages, e.g., increase stability and shelf-life. However, palatability and size are common difficulties in solid forms. Many aspects need to be considered when developing a new oral paediatric formulation, although, palatability is recognized as a common reason for non-compliance among children. There are many methods that can be used to improve palatability; however, innovative approaches are still needed. In this review, an overview on oral paediatric formulations with emphasis on their palatability is given. Some of the most innovative approaches are discussed, for example, the use of crystal engineering to improve drug palatability, the development of candy-like pharmaceutical forms, and the use of 3D printing to develop personalized medicines for children.

Keywords: Candy-like formulations; Crystal engineering; Drug palatability; Formulations acceptability; Oral paediatric formulations; Personalized medicine.