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Article

Accuracy of Dose Administered to Children Using Off-Labelled or Unlicensed Oral Dosage Forms

1
Pharmacy, Poitiers Teaching Hospital, 86000 Poitiers, France
2
School of Medicine and Pharmacy, University of Poitiers, 86000 Poitiers, France
3
Pediatrics Department, Nîmes Teaching Hospital, 30000 Nîmes, France
*
Author to whom correspondence should be addressed.
Academic Editors: Laura Modica de Mohac and Dimitrios A. Lamprou
Pharmaceutics 2021, 13(7), 1014; https://doi.org/10.3390/pharmaceutics13071014
Received: 7 June 2021 / Revised: 30 June 2021 / Accepted: 1 July 2021 / Published: 2 July 2021
(This article belongs to the Special Issue Advance in Development of Patient-Centric Dosage Form)
The pediatric population suffers from a lack of age-appropriate medicines leading to unsafe situations when off-labelled or unlicensed drugs are used. Assessing the best option to administrate medicines when manipulations are required is essential in order to improve child care. This study aimed to compare the accuracy of the administered dose provided by three dosage forms and their techniques of administration. Different techniques of administration were assessed, covering three oral dosage forms (commercially available tablets, capsules, oral suspensions) using two APIs not available in a children-adapted dosage form. Techniques of administration were simulated and administered doses were determined using HPLC-UV. Means were compared to the target dose while distributions of doses were compared between each technique. For both APIs, mean administered doses obtained with capsules and tablets were significantly different from the target dose, whereas there was no statistical difference with oral suspensions. Distributions of doses showed significant difference between the three dosage forms. This study demonstrates that manipulations of solid oral dosage forms provide dramatic underdosing leading to unsafe situations. Compounded oral suspension is the best option to avoid underdosing and dose variation. This solution should be prioritized when age-appropriate commercial medicines are not available. View Full-Text
Keywords: administration management; drug administration; pediatric medicine; personalized medicine; off-labelled dosage forms administration management; drug administration; pediatric medicine; personalized medicine; off-labelled dosage forms
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MDPI and ACS Style

Binson, G.; Sanchez, C.; Waton, K.; Chanat, A.; Di Maio, M.; Beuzit, K.; Dupuis, A. Accuracy of Dose Administered to Children Using Off-Labelled or Unlicensed Oral Dosage Forms. Pharmaceutics 2021, 13, 1014. https://doi.org/10.3390/pharmaceutics13071014

AMA Style

Binson G, Sanchez C, Waton K, Chanat A, Di Maio M, Beuzit K, Dupuis A. Accuracy of Dose Administered to Children Using Off-Labelled or Unlicensed Oral Dosage Forms. Pharmaceutics. 2021; 13(7):1014. https://doi.org/10.3390/pharmaceutics13071014

Chicago/Turabian Style

Binson, Guillaume, Cécile Sanchez, Karen Waton, Adeline Chanat, Massimo Di Maio, Karine Beuzit, and Antoine Dupuis. 2021. "Accuracy of Dose Administered to Children Using Off-Labelled or Unlicensed Oral Dosage Forms" Pharmaceutics 13, no. 7: 1014. https://doi.org/10.3390/pharmaceutics13071014

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