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Paediatric specific dosage forms: Patient and formulation considerations
Dilawar Khan1, Daniel Kirby1, Simon Bryson2
1Aston Pharmacy School, College of Health and Life Sciences, Aston University, Birmingham B4 7ET, UK.
Insights
Developing safe and effective pediatric medicines is challenging due to unique physiological differences. This review explores drug delivery, pharmacokinetics, and adherence factors in children.
Area of Science:
- Pediatric Pharmacology
- Drug Delivery Systems
- Clinical Pharmacy
Background:
- Limited availability of high-quality pediatric formulations presents a significant challenge.
- Approximately 50% of long-term medications and 10% of pediatric prescriptions are non-adherent, off-label, or unlicensed.
Purpose of the Study:
- To review factors influencing the safety, toxicity, and efficacy of pediatric drug delivery.
- To discuss anatomical, physiological, and pharmacokinetic differences in pediatric populations.
- To assess current and innovative pediatric dosage forms and adherence strategies.
Main Methods:
- Literature review of pediatric drug formulation, pharmacokinetics, and adherence.
- Analysis of anatomical and physiological differences between pediatric subsets and adults.
- Evaluation of existing and novel pediatric dosage forms.
Main Results:
- Significant anatomical and physiological variations exist within pediatric subsets, impacting drug absorption, distribution, metabolism, and elimination.
- Current pediatric dosage forms have limitations, with innovative small, flexible solid oral dosage forms showing promise.
- Factors affecting pediatric medicine adherence include formulation, administration route, and patient/caregiver acceptance.
Conclusions:
- Understanding pediatric-specific physiological differences is crucial for safe and effective drug development.
- Optimizing pediatric drug delivery requires addressing pharmacokinetic variations and improving dosage form acceptability.
- Strategies to enhance adherence are essential for improving therapeutic outcomes in children.
Abstract:
The total number of paediatric formulations available only account for a small proportion of the full therapeutic plethora required to effectively treat paediatrics and, therefore, the availability of high quality medicines designed specifically for children remains an ongoing challenge. Currently, the World Health Organisation (WHO) report that around 50% of medication issued for long-term conditions are not taken as advised, whilst it has also been established that, in general practice, around one tenth of medicines prescribed for children are either off-label or unlicensed. Such off-label and unlicensed use is owing to the considerable anatomical and physiological differences observed between paediatric subsets. Identifying such differences, is essential for better informing paediatric drug development and assisting regulatory reviews, whilst ensuring safe and effective therapeutic concentrations of pharmacological substances. Points covered: The review discusses factors affecting the safety, toxicity and efficacy of paediatric drug delivery systems. The research highlights features of the gastrointestinal tract and reports anatomical and physiological differences between paediatrics and adults. Additionally, differences observed in paediatric pharmacokinetic profiles (absorption, distribution, metabolism and elimination) due to physiological differences are also discussed. Furthermore, this review considers the advantages and limitations of current paediatric specific dosage forms available and assesses the acceptability of innovative small flexible solid oral dosage forms. Lastly, this review highlights factors affecting paediatric medicine adherence and acceptability and discusses the techniques available to overcome barriers associated with non-adherence.
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