Journal
PHARMACEUTICS
Volume 13, Issue 7, Pages -Publisher
MDPI
DOI: 10.3390/pharmaceutics13071014
Keywords
administration management; drug administration; pediatric medicine; personalized medicine; off-labelled dosage forms
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This study compared the accuracy of administered doses provided by three dosage forms and their techniques of administration. Results showed that mastering the techniques of dosage forms is crucial for reducing underdosing and dose variation in pediatric population.
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.
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