Acceptability of an orodispersible film compared to syrup in neonates and infants: A randomized controlled trial

Klingmann, Viviane; Pohly, Christoph Emanuel; Meißner, Thomas; Mayatepek, Ertan; Möltner, Andreas; Flunkert, Kathrin; Breitkreutz, Jörg; Bosse, Hans Martin

doi:10.1016/j.ejpb.2020.03.018

Cited by 39 publications

(26 citation statements)

References 15 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Nevertheless, flavors or sweeteners should be needed as taste and grittiness remain central considerations [ 4 ]. Klingmann et al, demonstrated that oral thin films are a suitable alternative to liquid pediatric formulations in neonates [ 29 ]. Mini-tablets could also be an alternative for future development.…”

Section: Discussionmentioning

confidence: 99%

Medicines Acceptability in Hospitalized Children: An Ongoing Need for Age-Appropriate Formulations

Vallet¹,

Elhamdaoui

Berraho

et al. 2020

Pharmaceutics

View full text Add to dashboard Cite

Although knowledge on medicine acceptability remains fragmented, this multi-faceted concept has emerged as a key factor for compliance in pediatrics. In order to investigate the acceptability of medicines used in the University Medical Centre Ibn Sina (CHIS) of Rabat, Morocco, an observational study was conducted. Using a multivariate approach integrating the many aspects of acceptability, standardized observer reports were collected for 570 medicine intakes in patients up to the age of 16, then analyzed on a reference framework. Tablets appeared to be well accepted in children greater than 6 years old, but were crushed/dissolved for 90% of the 40 children aged from 3 to 5, and 100% of the 38 patients younger than 3. Moreover, the prescribed dose was fully taken for only 52% and 16% of these younger children, respectively. Despite this, tablets represented 24% of evaluations in children from 3 to 5 and 20% in infants and toddlers. Oral liquid preparations appeared to be better accepted than tablets in preschoolers, but not for those under 3. Overall, these findings highlight the lack of suitable alternatives for the younger children, especially for formulations of antiepileptics, antithrombotic, and psycholeptic agents in the local context.

show abstract

Section: Discussionmentioning

confidence: 99%

Medicines Acceptability in Hospitalized Children: An Ongoing Need for Age-Appropriate Formulations

Vallet¹,

Elhamdaoui

Berraho

et al. 2020

Pharmaceutics

View full text Add to dashboard Cite

show abstract

“…Study_2: "Acceptability of an orodispersible film compared to syrup in neonates and infants: A randomized controlled trial", Klingmann et al [9]. In total, 150 children stratified into 3 age groups were included (2 to 28 days, 29 days to 5 months, > 5 to 12 months).…”

Section: Resultsmentioning

confidence: 99%

“…This project is intended to establish and validate an acceptability test system as a composite endpoint based on deglutition and palatability, for which established, broadly accepted definitions are used (Klingmann et al [5][6][7][8][9][10]) in boys and girls from newborn to 18 years across different races comparing four oral pediatric drug formulations: syrup, mini-tablets, capsules and tablets. It is intended to broadly discuss the results with academic and industry experts, clinicians, regulators and patients to provide an internationally accepted method for acceptability assessment.…”

Section: Introductionmentioning

confidence: 99%

A composite endpoint for acceptability evaluation of oral drug formulations in the pediatric population

Wargenau¹,

Reidemeister

Klingmann³

et al. 2021

Preprint

Self Cite

View full text Add to dashboard Cite

IntroductionA medicine’s acceptability is likely to have significant impact on pediatric compliance. EMA and FDA guidance on this topic ask for investigation of acceptability. Although palatability and deglutition are denoted as elements of acceptability, the impact of both on acceptability remains unclear as an unambiguous definition of acceptability is lacking. Actually, globally applied standards for acceptability definition, testing methodology and assessment criteria do not exist. A definition of acceptability establishing a composite endpoint that combines deglutition and palatability in different age groups is presented here.MethodsThis composite acceptability endpoint is based on validated assessment methods for deglutition and palatability in children of different age groups with different galenic placebo formulations, in line with criteria EMA proposed for assessing acceptability in children from newborn to 18 years. Data from two studies investigating mini-tablets, oblong tablets, orodispersible films and syrup were used to investigate the validity, expediency and applicability of the suggested composite acceptability assessment tool.ResultsThe new composite endpoint is highly suitable and efficient to distinguish preferences of oral formulations: Mini-tablets and oblong tablets were significantly better accepted than syrup and orodispersible film.ConclusionSince the suggested acceptability criterion takes both deglutition and palatability into account as composite endpoint, it is highly sensitive to detect acceptability differences between oral formulations. It is a well-defined, valid approach, which particularly meets regulatory requirements in an appropriate and comprehensive manner and may in future serve as an easy, standardized method to assess and compare acceptability of pediatric formulations with active substances.

show abstract

“…A previous study assessing the acceptability of orodispersible films in children found that 83% of caregivers were unfamiliar with this dosage form before the study. The few acceptability studies that focused on orodispersible films reported positive feedbacks from children and their caregivers [ 19 , 20 ]; nonetheless, orodispersible films are currently only used for niche clinical conditions.…”

Section: Discussionmentioning

confidence: 99%

Children’s Preferences for Oral Dosage Forms and Their Involvement in Formulation Research via EPTRI (European Paediatric Translational Research Infrastructure)

et al. 2021

View full text Add to dashboard Cite

The paucity of evidence-based data on formulation characteristics preferred by the children is known to limit the design of tailored paediatric dosage forms. The European Paediatric Translational Research Infrastructure (EPTRI) commissioned a study to evaluate children’s dosage forms perceived preferences in some European countries and explore the feasibility of using the young persons advisory groups (YPAGs) to involve children in formulation research. An online, age-adapted survey was developed and translated into six languages. The survey link was disseminated across seven European countries: Albania, Italy, the Netherlands, and Dutch-speaking part of Belgium, Romania, Spain, and the United Kingdom. Respondents’ (n = 1172) perceived preferences for oral dosage forms primarily differed based on age, health status, and experience. Conventional dosage forms, i.e., liquid (35%), tablets (19%), and capsules (14%), were the most selected. Liquid was widely selected by children less than 12 years and by those healthy and taking medicines rarely. Monolithic solid forms were mostly chosen by adolescents and by children with a chronic disease taking medicines frequently. There was a clear lack of familiarity with more novel dosage forms (e.g., orodispersible films and granules). Noteworthy, granules were not appreciated, particularly by adolescents (52.8%). To rationalise the creation of paediatric formulations, it is important to involve children as active stakeholders and to apply tools assessing children’s perspectives on medicines to inform acceptable dosage form development from the start.

show abstract

Acceptability of an orodispersible film compared to syrup in neonates and infants: A randomized controlled trial

Cited by 39 publications

References 15 publications

Medicines Acceptability in Hospitalized Children: An Ongoing Need for Age-Appropriate Formulations

Medicines Acceptability in Hospitalized Children: An Ongoing Need for Age-Appropriate Formulations

A composite endpoint for acceptability evaluation of oral drug formulations in the pediatric population

Children’s Preferences for Oral Dosage Forms and Their Involvement in Formulation Research via EPTRI (European Paediatric Translational Research Infrastructure)

Contact Info

Product

Resources

About