Dokument: Evaluation verschiedener Messmethoden zur Beurteilung der Schluckbarkeit und Schmackhaftigkeit von Tabletten bei Proband*innen im Alter ≥12 Jahre für die Entwicklung eines standardisierten Verfahrens
| Titel: | Evaluation verschiedener Messmethoden zur Beurteilung der Schluckbarkeit und Schmackhaftigkeit von Tabletten bei Proband*innen im Alter ≥12 Jahre für die Entwicklung eines standardisierten Verfahrens | |||||||
| URL für Lesezeichen: | https://docserv.uni-duesseldorf.de/servlets/DocumentServlet?id=74042 | |||||||
| URN (NBN): | urn:nbn:de:hbz:061-20260812-113353-6 | |||||||
| Kollektion: | Dissertationen | |||||||
| Sprache: | Deutsch | |||||||
| Dokumententyp: | Wissenschaftliche Abschlussarbeiten » Dissertation | |||||||
| Medientyp: | Text | |||||||
| Autor: | Spittel, Sonja [Autor] | |||||||
| Dateien: |
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| Beitragende: | Prof. Dr. med. Bosse, Hans Martin [Gutachter] Prof. Dr. med. Lehwald-Tywuschik, Nadja [Gutachter] | |||||||
| Stichwörter: | EMG, BI, Schluckbarkeit, Schmackhaftigkeit, Akzeptanz, Tablettenform, Tablettengröße, orale Darreichungsform | |||||||
| Dewey Dezimal-Klassifikation: | 600 Technik, Medizin, angewandte Wissenschaften » 610 Medizin und Gesundheit | |||||||
| Beschreibungen: | Die Einnahme fester oraler Darreichungsformen (FOD) stellt für Patient*innen verschiedener Altersgruppen eine erhebliche Herausforderung dar. Zur Reduktion einnahmebedingter Medikationsprobleme ist die Bereitstellung standardisierter und validierter Bewertungsverfahren erforderlich, um patientengerechte sowie sichere Formulierungen entwickeln zu können.
In dieser monozentrischen, kontrollierten, offenen und randomisierten Studie wurden 280 Proband*innen im Alter ab ≥12 Jahren untersucht, gleichmäßig verteilt auf fünf Altersgruppen mit ausgeglichener Geschlechterverteilung. Ziel der Studie war der methodische Vergleich dreier Verfahren zur Bewertung der Schluckbarkeit und Schmackhaftigkeit von FOD, darunter eine apparative Messmethode zur Untersuchung der Schluckvorgänge mittels Elektromyographie (EMG) und Bioimpedanz (BI), eine objektive Bewertung nach definierten Auswertungskriterien (zusammengesetzter Endpunkt, ZEP) und eine subjektive Einschätzung mittels Fragebogen. Dabei wurden Einflussfaktoren wie Alter, Geschlecht, Anwendungserfahrung sowie Tablettenform und -größe hinsichtlich ihrer Auswirkungen auf die Akzeptanz und den Schluckvorgang analysiert. Fragebogen und ZEP, die zuvor in pädiatrischen Studien entwickelt und validiert worden waren, wurden erstmals bei Erwachsenen angewendet. Zur Erstellung individueller Schluckprofile erfolgten Messungen beim Schlucken von Speichel, Wasser und Brot. Anschließend erhielten die Proband*innen vier Placebo-Tabletten in randomisierter Reihenfolge: „klein-rund“ (6 mm), „groß-rund“ (13 mm), „klein-oblong“ (6 × 2,5 mm) und „groß-oblong“ (14,5 × 5,7 mm). Im Fragebogen war die allgemeine Schluckbarkeit der Tablette „klein-rund“ am höchsten (86,8% „zufrieden“ oder „sehr zufrieden“), gefolgt von der Tablette „klein-oblong“ (83,9%). Die Tablette „groß-rund“ wurde am häufigsten negativ bewertet (51,1% „unzufrieden“ oder „sehr unzufrieden“). Im ZEP wurden die beiden kleinen Formulierungen gleich gut bewertet (96,4% „mindestens gut“), während die Akzeptanz „mindestens gut“ bei der Tablette „groß-oblong“ niedriger (81,1%) und bei der großen runden Tablette erneut am niedrigsten (67,1%) war. EMG- und BI- Messungen bestätigten, dass die Tablettengröße das Schluckverhalten signifikant beeinflusst, wobei kleinere Tabletten eine kürzere Dauer der Kehlkopfhebung und des Schluckvorgangs sowie ein geringeres Ausmaß und ein geringeres Maximum der EMG-Aktivität erforderten. Zwi schen den Tablettenformen bestanden überwiegend keine signifikanten Unterschiede, lediglich bei Einnahme der Tablette „groß-rund“ zeigte sich ein erhöhtes Ausmaß der EMG-Aktivität. Altersabhängige und geschlechtsspezifische Unterschiede in Akzeptanz und Schluckverhalten waren gering. Einnahmeerfahrung erhöhte die Akzeptanz von kleinen Tabletten. Fragebogen und ZEP zeigten somit übereinstimmend eine höhere Schluckbarkeit, Schmackhaftigkeit und Akzeptanz kleiner Tabletten, mit der geringsten Präferenz für die große runde Formulierung. Die Ergebnisse der EMG- und BI-Messungen stehen mit dieser Bewertung im Einklang, was auf eine insgesamt höhere Schluckbelastung bei Einnahme größerer Tabletten hinweist. Die Studienergebnisse bestätigen die Validität und Reliabilität von Fragebogen und ZEP, da sich frühere Ergebnisse zu Form- und Größenpräferenzen reproduzieren ließen. Zudem konnte die Anwendbarkeit beider Methoden auf andere Altersgruppen belegt werden. Objektive und subjektive Methoden erfassen leicht unterschiedliche, sich jedoch ergänzende Dimensionen der Fragestellung. Die EMG-/BI-Messung erwies sich als nützlich zur objektiven Quantifizierung des Schluckablaufs, bot jedoch keinen wesentlichen Mehrwert gegenüber weniger aufwändigen Verfahren wie ZEP oder Fragebogen.Taking solid oral dosage forms (FOD) poses a considerable challenge for patients of various age groups. In order to reduce medication problems related to intake, standardized and validated assessment methods are required to develop patient-friendly and safe formulations. In this monocentric, controlled, open-label, randomized study, 280 subjects aged ≥12 years were examined, evenly distributed across five age groups with a balanced gender distribution. The aim of the study was to methodically compare three methods for assessing swallowability and palatability of FOD, including an instrumental measurement of swallowing processes using electromyography (EMG) and bioimpedance (BI), an objective observation of gestures and facial expressions according to standardized criteria (composite endpoint, ZEP), and a subjective assessment using a questionnaire. Influencing factors such as age, gender, experience of use, and tablet shape and size were analyzed in terms of their effects on acceptance and swallowing process. Questionnaires and ZEP, which had previously been developed and validated in pediatric studies, were applied to adults for the first time. Measurements were taken while swallowing saliva, water, and bread to create individual swallowing profiles. The subjects then received four placebo tablets in randomized order: “small-round” (6 mm), “large round” (13 mm), “small-oblong” (6 × 2.5 mm), and “large-oblong” (14.5 × 5.7 mm). In the questionnaire, general swallowability of the “small round” tablet was highest (86.8% “satisfied” or “very satisfied”), followed by the “small oblong” tablet (83.9%). The “large round” tablet received the most negative ratings (51.1% “dissatisfied” or “very dissatisfied”). In ZEP, the two small formulations were rated equally well (96.4% “at least good”), while acceptance as “at least good” was lower for the “large oblong” tablet (81.1%) and lowest for the large round tablet (67.1%). EMG and BI measurements confirmed that tablet size significantly influences swallowing behavior, with smaller tablets requiring a shorter duration of laryngeal elevation and swallowing process, as well as a lower extent and maximum of EMG activity. There were no significant differences between the tablet shapes, with the exception of the large round tablet, which showed an increased level of EMG activity. Age-related differences in acceptance and swallowing process were minor. There also were hardly any gender-specific effects. Experience with taking tablets increased the acceptance of small tablets. The questionnaire and ZEP consistently showed a higher swallowability, palatability, and acceptability of small tablets, with the lowest preference for the large round formulation. The results of the EMG and BI measurements are consistent with this assessment, which may indicate a higher overall swallowing burden when taking larger tablets. The study results confirm the validity and reliability of the questionnaire and ZEP, as previous findings on shape and size preferences could be reproduced. In addition, the applicability of both methods to other age groups could be demonstrated. Objective and subjective methods capture slightly different but complementary dimensions of the question. EMG/BI measurement proved useful for objectively quantifying the swallowing process but did not offer any significant added value compared to less complex methods such as ZEP or questionnaires. | |||||||
| Quelle: | Alqahtani, M.S., et al., Advances in Oral Drug Delivery. Front Pharmacol, 2021. 12: p. 618411.
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| Fachbereich / Einrichtung: | Medizinische Fakultät | |||||||
| Dokument erstellt am: | 12.08.2026 | |||||||
| Dateien geändert am: | 12.08.2026 | |||||||
| Promotionsantrag am: | 02.02.2026 | |||||||
| Datum der Promotion: | 16.07.2026 |
