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Published on: February 3, 2023
Formulation factors affecting acceptability of oral medicines in children
Fang Liu1, Sejal Ranmal2, Hannah K Batchelor3
1Department of Pharmacy, School of Life and Medical Sciences, University of Hertfordshire, Hatfield AL10 9AB, UK.
Insights
Medicines
Area of Science:
- Pharmaceutical Sciences
- Paediatric Medicine
- Drug Formulation
Background:
- Medicinal product acceptability in children and caregivers is crucial for treatment safety and efficacy.
- Regulatory bodies require demonstration of paediatric formulation acceptability during product development.
- Current scientific evidence on age-appropriateness and acceptability of different dosage forms is fragmented.
Purpose of the Study:
- To highlight formulation factors influencing the acceptability of oral medicines in children.
- To identify knowledge gaps in paediatric formulation development.
- To explore the utility of adult study findings for paediatric drug development.
Main Methods:
- Review of scientific literature on medicine acceptability in children.
- Analysis of formulation factors impacting oral medicine acceptance.
- Discussion of findings from adult population studies relevant to paediatrics.
Main Results:
- Formulation characteristics significantly impact the acceptability of oral medicines for paediatric patients.
- Specific formulation factors require further investigation for diverse paediatric populations.
- Adult data can offer preliminary insights for paediatric formulation strategies.
Conclusions:
- Understanding formulation factors is key to improving paediatric medicine acceptability.
- Further research is needed to address knowledge gaps in paediatric drug formulation.
- A strategic approach integrating existing knowledge and new research is essential for effective paediatric formulation development.
Abstract:
Acceptability of medicines in children and caregivers affects safety and effectiveness of medicinal treatments. The pharmaceutical industry is required to demonstrate acceptability of new paediatric formulations in target age groups as an integrated part of the development of these products (Kozarewicz, 2014). Two questions arise when trying to tackle this task: "which dosage form to choose for each target age group?" and "how to formulate it once the dosage form is decided?". Inevitably, both the regulator and the developer turn to scientific evidence for answers. Research has emerged in recent years to demonstrate age-appropriateness and patient acceptability of different dosage forms; however, such information is still fragmented and far from satisfactory to define efficient formulation development strategies for a diverse patient subset (Ranmal and Tuleu, 2013). This paper highlights how formulation factors affect the acceptability of different oral medicines in children (Table 1), and it is based on a more extensive review article by Liu et al. (Liu et al., 2014). Gaps in knowledge are highlighted in order to stimulate further research. In some areas, findings from studies conducted in adult populations may provide useful guidance for paediatric development and this is also discussed.
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