Paediatric specific dosage forms: Patient and formulation considerations


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.

Divisions: College of Health & Life Sciences > Aston Pharmacy School
College of Health & Life Sciences > Chronic and Communicable Conditions
College of Health & Life Sciences
Additional Information: Crown Copyright © 2022 Published by Elsevier B.V. This is an open access article under the CC BY license (
Publication ISSN: 1873-3476
Last Modified: 29 Nov 2023 13:14
Date Deposited: 08 Mar 2022 15:37
Full Text Link: 10.1016/j.ijpharm.2022.121501
Related URLs: https://www.sci ... 0540?via%3Dihub (Publisher URL)
PURE Output Type: Article
Published Date: 2022-03-25
Published Online Date: 2022-01-29
Accepted Date: 2022-01-18
Submitted Date: 2021-11-10
Authors: Khan, Dilawar
Kirby, Daniel
Bryson, Simon
Shah, Maryam
Rahman Mohammed, Afzal



Version: Accepted Version

Access Restriction: Restricted to Repository staff only


Version: Published Version

License: Creative Commons Attribution

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