Dokument: Mini-tablets as an alternative galenic formulation for neonates - A single-centre, randomised, open, two-way, cross-over study investigating the acceptability and swallowability of two different oral placebo formulations in neonates
| Titel: | Mini-tablets as an alternative galenic formulation for neonates - A single-centre, randomised, open, two-way, cross-over study investigating the acceptability and swallowability of two different oral placebo formulations in neonates | |||||||
| Weiterer Titel: | Mini-Tabletten als eine alternative galenische Formulierung für Neugeborene - Eine monozentrische, randomisierte, offene, Cross-over Studie zur Untersuchung von Akzeptanz und Schluckbarkeit von zwei oralen Placebo-Formulierungen durch Neugeborene | |||||||
| URL für Lesezeichen: | https://docserv.uni-duesseldorf.de/servlets/DocumentServlet?id=49359 | |||||||
| URN (NBN): | urn:nbn:de:hbz:061-20190416-092822-5 | |||||||
| Kollektion: | Dissertationen | |||||||
| Sprache: | Englisch | |||||||
| Dokumententyp: | Wissenschaftliche Abschlussarbeiten » Dissertation | |||||||
| Medientyp: | Text | |||||||
| Autor: | Seitz, Annika [Autor] | |||||||
| Dateien: |
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| Beitragende: | PD Dr. Meißner, Thomas [Gutachter] Prof. Dr. Kojda, Georg [Gutachter] | |||||||
| Dewey Dezimal-Klassifikation: | 600 Technik, Medizin, angewandte Wissenschaften » 610 Medizin und Gesundheit | |||||||
| Beschreibungen: | In der Pädiatrie ist der Mangel an evidenzbasierten Empfehlungen zu galenischen Darreichungsformen noch immer sehr hoch. Unpassende Darreichungsformen können zur ungenauen Dosierung führen. Dieses Problem ist besonders groß bei Neugeborenen, der verwundbarsten Altersgruppe. So müssen beispielsweise Medikamente auf Neugeborenen-Intensivstationen in bis zu 90% der Fälle off-label eingesetzt werden.
Aktuell werden orale Medikamente meist in Form von flüssigen Lösungen oder Sirup verabreicht, sehr oft als selbst hergestellte Lösungen aus festen Darreichungsformen. Die Gefahr ungenauer Dosierung ist dabei sehr hoch. Des Weiteren werden zum Teil schädliche Inhalts- und Füllstoffe verwendet. Die Notwendigkeit, adäquate altersgerechte galenische Darreichungsformen auch für die jüngsten Patienten bereitzustellen, liegt klar auf der Hand. In den letzten Jahren wurden von der European Medicines Agency (EMA) und der Weltgesundheitsorganisation (WHO) viele Ansätze entwickelt, klinisch-pharmazeutische Studien an Kindern attraktiver zu machen und somit den evidenzbasierten Einsatz von Medikamenten auch im Feld der Pädiatrie zu erhöhen. Trotzdem gibt es noch immer einen hohen Forschungsbedarf, insbesondere im Bereich der Neonatologie. Unsere Studiengruppe hat in der Vergangenheit bereits zwei klinische Studien an insgesamt 355 Kindern im Alter von 0,5 bis 6 Jahren durchgeführt. Die damit gewonnen Daten zeigen, dass sowohl die Akzeptanz als auch die Schluckbarkeit von Minitabletten in diesen Altersgruppen höher sind als die von Sirup. Da es bisher noch keine Daten zu diesen Parametern bei Neugeborenen gab, hat unsere Studiengruppe eine klinische Studie mit 151 Neugeborenen durchgeführt. Es konnte nicht nur gezeigt werden, dass Neugeborene die Minitabletten akzeptieren (100%, 95% KI: 97,6%-100%), sondern auch, dass die Schluckbarkeit von ihnen signifikant größer ist als von Sirup (Δ10%; 95% CI 1.37%-19.34%; p=0.0315). Schlussfolgerung: Minitabletten können sicher von Neugeborenen geschluckt werden, was sie zu einer ernstzunehmenden Alternative zu anderen galenischen Darreichungsformen wie Sirup macht.In the field of paediatrics the lack of evidence-based knowledge about treatment options for children is still remarkably high, which may result in administration of inaccurate dosages and inappropriate formulations of drugs in young patients. This problem occurs even more in neonates, the most vulnerable age group. As a result, an off-label drug use of up to 90% in Neonatal Intensive Care Units (NICUs) has been estimated. Currently, oral medication is given to neonates in the form of liquid solutions or syrup. This has a high potential of inaccurate dosing and therefore may result in over- or underdosing. In addition sometimes harmful ingredients and bulking agents are used to create the syrups. Obviously, there is a need to investigate appropriate, age-adapted galenic formulations even for the youngest. In the last years there have been many approaches by the European Medicines Agency (EMA) and World Health Organization (WHO) to undertake clinical pharmaceutical trials involving children more attractive and therefore to increase the evidence-based knowledge of paediatric medication. Nevertheless, there is still a huge need for clinical studies especially in the neonatal period. Our study group of the Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie of the Universitätsklinikum Düsseldorf has already performed 2 trials with 355 children aged 0.5 to 6 years, providing data that the acceptability as well as the swallowability of mini tablets is higher in these age groups compared to, for example, syrup. Based on a lack of data investigating acceptability and swallowability of mini tablets in neonates, the trial team, including the writer of this thesis, has performed a study involving 151 neonates with the aim to close the gap in factual knowledge about this age group. The trial could not only show that neonates accept the mini-tablets (100%, 95% CI: 97,6%-100,0%) but also that the swallowability is significantly higher in mini-tablets than in syrup (Δ10%; 95% CI 1.37%-19.34%; p=0.0315). In conclusion, it can be said that neonates are able to swallow mini-tablets safely, which makes them a considerable alternative to other galenic formulations like syrup. | |||||||
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| Lizenz: |  Urheberrechtsschutz | |||||||
| Fachbereich / Einrichtung: | Medizinische Fakultät | |||||||
| Dokument erstellt am: | 16.04.2019 | |||||||
| Dateien geändert am: | 16.04.2019 | |||||||
| Promotionsantrag am: | 05.07.2018 | |||||||
| Datum der Promotion: | 11.04.2019 |
