Dokument: Validating a composite endpoint for acceptability evaluation of oral drug formulations in the pediatric population: a randomized, open-label, single dose, cross-over study
| Titel: | Validating a composite endpoint for acceptability evaluation of oral drug formulations in the pediatric population: a randomized, open-label, single dose, cross-over study | |||||||
| URL für Lesezeichen: | https://docserv.uni-duesseldorf.de/servlets/DocumentServlet?id=68452 | |||||||
| URN (NBN): | urn:nbn:de:hbz:061-20250205-131914-5 | |||||||
| Kollektion: | Publikationen | |||||||
| Sprache: | Englisch | |||||||
| Dokumententyp: | Wissenschaftliche Texte » Artikel, Aufsatz | |||||||
| Medientyp: | Text | |||||||
| Autoren: | Münch, Juliane [Autor] Schwarzwälder, Anna Lena [Autor] Kloft, Carolin [Autor] Bosse, Hans Martin [Autor] Wargenau, Manfred [Autor] Reidemeister, Sibylle [Autor] Klingmann, Ingrid [Autor] Klingmann, Viviane [Autor] | |||||||
| Dateien: |
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| Stichwörter: | acceptability, palatability, oral pediatric formulations, swallowability, drug administration | |||||||
| Beschreibung: | Objective: This study aimed to validate the newly developed composite acceptability endpoint to investigate acceptability of oral pediatric drug formulations that integrates swallowability and palatability assessments.
Methods: In this open-label study acceptability of oral formulations was tested in three age groups (1–<6 months, 6–<12 years, and 12–<18 years) with a 2-way cross-over design in children aged 1–<6 months (syrup and mini-tablets), and with an incomplete block design of four sequences with three out of four formulations (syrup, mini-tablets, oblong tablet, and round tablet) each in children aged 6–<18 years. The primary endpoint was acceptability derived from the composite acceptability endpoint. Secondary endpoints were palatability and acceptability derived from swallowability. Results: A total of 320 children were stratified into three age groups (80 children aged 1–<6 months, 120 children aged 6–<12 years, and 120 children aged 12–<18 years). All participants completed the study. Age-specific differences were observed in acceptability derived from the composite acceptability endpoint. Mini-tablets had the highest acceptability in participants aged 1–<6 months and 6–<12 years while the oblong tablet was leading in adolescent participants (12–<18 years). Conclusion: This study demonstrated that the composite acceptability endpoint method integrating both swallowability and palatability assessments is a sensitive method to assess acceptability of drug formulations in children of different age. | |||||||
| Rechtliche Vermerke: | Originalveröffentlichung:
Münch, J., Schwarzwälder, A. L., Kloft, C., Bosse, H. M., Wargenau, M., Reidemeister, S., Klingmann, I., & Klingmann, V. (2024). Validating a composite endpoint for acceptability evaluation of oral drug formulations in the pediatric population: a randomized, open-label, single dose, cross-over study. Frontiers in Pharmacology, 15, Article 1436554. https://doi.org/10.3389/fphar.2024.1436554 | |||||||
| Lizenz: |  Dieses Werk ist lizenziert unter einer Creative Commons Namensnennung 4.0 International Lizenz | |||||||
| Fachbereich / Einrichtung: | Medizinische Fakultät | |||||||
| Dokument erstellt am: | 05.02.2025 | |||||||
| Dateien geändert am: | 05.02.2025 |
