Paediatric specific dosage forms: Patient and formulation considerations

https://doi.org/10.1016/j.ijpharm.2022.121501Get rights and content
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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.

Keywords

Age-appropriate
Pediatrics
Medicine adherence
Pharmacokinetics
Anatomy
Physiology

Abbreviations

PK
Pharmacokinetic
GI
gastrointestinal
OTT
Oesophageal transit time
GORD
Gastro oesophageal Reflux Disease
BCS
Biopharmaceutical classification system
SFB
Segmented Filamentous Bacteria
P-gp
P-glycoprotein
EMA
European Medicines Agency
IT
Intestinal transit
BBB
Blood Brain Barrier
CNS
Central Nervous System
CYPs
Cytochromes P450
GFR
glomerular filtration rate
ODT
orally disintegrating tablets
MDF
Multi-particulate dosage forms
WHO
World Health Organisation
FDA
The United States Food and Drug Administration

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