Fadda, Hala M;
Weiler, Hannah;
Carvalho, Maria;
Lee, You Zhuan;
Dassouki, Hadi;
AbuBlan, Rasha;
Iurian, Sonia;
... Pauletti, Giovanni M; + view all
(2024)
Pediatric oral extemporaneous preparations and practices: International Pharmaceutical Federation (FIP) global study.
uropean Journal of Pharmaceutics and Biopharmaceutics
, 204
, Article 114483. 10.1016/j.ejpb.2024.114483.
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Abstract
This publication is the first to report current, global, pediatric oral extemporaneous compounding practices. Complete survey responses were received from 479 participants actively involved in compounding across all the World Health Organization (WHO) regions. The survey addressed oral formulation of extemporaneous liquids, including the use of commercial or in-house vehicles, flavoring excipients, source of formulation recipes, and beyond use dates (BUDs). Over 90% of the survey participants prepared oral liquids. Solid dosage forms, comprising capsules and powder papers (sachets), were also frequently prepared for children, albeit to a lesser extent. The top 20 active pharmaceutical ingredients compounded for children, globally, were: omeprazole, captopril, spironolactone, propranolol, furosemide, phenobarbital, hydrochlorothiazide, ursodeoxycholic acid, sildenafil, melatonin, clonidine, enalapril, dexamethasone, baclofen, caffeine, chloral hydrate, trimethoprim, atenolol, hydrocortisone, carvedilol and prednisolone. Diuretics, drugs for acid-related disorders, and beta-blockers were the top three most frequently compounded classes per the WHO Anatomical Therapeutic Chemical (ATC) classification system. The principal need identified for the practice of extemporaneous compounding for children was the development of an international, open-access formulary that includes validated formulations, as well as updated compounding literature and guidelines. Furthermore, improved access to data from stability studies to allow compounding of formulations with extended BUDs.
| Type: | Article |
|---|---|
| Title: | Pediatric oral extemporaneous preparations and practices: International Pharmaceutical Federation (FIP) global study |
| DOI: | 10.1016/j.ejpb.2024.114483 |
| Publisher version: | https://doi.org/10.1016/j.ejpb.2024.114483 |
| Language: | English |
| Additional information: | This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions. |
| Keywords: | Age-appropriate medicines, Patient-centric, Infant, Toddler, Formulation, Solution, Suspension, Beyond use date, WHO Essential Medicines, Pediatric Investigation Plan (PIP), Pediatric Research Equity Act (PREA), Best Pharmaceuticals for Children Act (BPCA) |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences > UCL School of Pharmacy UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences > UCL School of Pharmacy > Pharmaceutics |
| URI: | https://discovery-pp.ucl.ac.uk/id/eprint/10196776 |
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