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Original research
Acceptability of multiple coated mini-tablets in comparison to syrup in infants and toddlers: a randomised controlled study
  1. Viviane Klingmann1,
  2. Markus Hinder2,
  3. Thomas H Langenickel3,
  4. Fabian Chen4,
  5. Yasser Khder5,
  6. Jörg Breitkreutz6,
  7. Hans Martin Bosse1
  1. 1 Department of General Paediatrics, Neonatology and Paediatric Cardiology, Heinrich Heine University Düsseldorf, Düsseldorf, Germany
  2. 2 Novartis Global Drug Development, Chief Medical Office & Patient Safety, Basel, Switzerland
  3. 3 Ethris GmbH, Planegg, Germany
  4. 4 Gene Therapy Program, University of Pennsylvania, Philadelphia, Pennsylvania, USA
  5. 5 MYRA Life Science Services, Rosenau, France
  6. 6 Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University, Düsseldorf, Germany
  1. Correspondence to Dr Viviane Klingmann, Department of General Paediatrics, Neonatology and Paediatric Cardiology, Heinrich Heine University Düsseldorf, Düsseldorf 40225, Germany; viviane.klingmann{at}med.uni-duesseldorf.de

Abstract

Objectives Drug treatment of children is often limited to liquid formulations or manipulation of adult solid oral dosage forms because of the lack of age-appropriate formulations, concerns around particle aspiration and paediatric acceptability. Recent research revealed that the administration of mini-tablets has substantial advantages in improving dose accuracy and avoiding issues related to drug stability, storage conditions, potentially toxic excipients and taste masking (especially effective when the mini-tablets are coated). Most trials were performed with single and multiple uncoated mini-tablets. This study here aimed to investigate young children’s acceptability and swallowability of multiple coated placebo mini-tablets compared with glucose syrup.

Design This clinical trial was conducted as a single-centre randomised cross-over study.

Setting Prospective cross-over study performed at the Children′s University Hospital Düsseldorf.

Patients This study was conducted on 50 children in five age groups from 1 to <6 years.

Interventions An age-adapted amount of 16–28 mini-tablets and 3–6 mL syrup was administered in randomised order.

Main outcome measures Acceptability and swallowability of multiple coated mini-tablets and syrup.

Results In all age groups, administration of multiple coated mini-tablets and syrup showed good acceptability (mini-tablets 80%–100%, syrup 90%–100%) and swallowability (mini-tablets 30%–70%, syrup 20%–80%) without any clinically meaningful difference. This is consistent with results from large studies with uncoated mini-tablets.

Conclusion Multiple coated mini-tablets are a suitable age-appropriate alternative to liquid formulations in the paediatric population. No safety concerns with the use of coated mini-tablets were observed in the study.

Trial registration number DRKS00010395.

  • paediatrics
  • pharmacology
  • therapeutics

Data availability statement

Data are available on reasonable request. Individual participant data from this study will be available in an anonymised form from the publication date of this manuscript for the following 24 months on a collaborative basis for individual participant data meta-analyses. Proposals should be directed to the corresponding author.

https://doi.org/10.1136/archdischild-2022-325264

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    Data availability statement

    Data are available on reasonable request. Individual participant data from this study will be available in an anonymised form from the publication date of this manuscript for the following 24 months on a collaborative basis for individual participant data meta-analyses. Proposals should be directed to the corresponding author.

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    Footnotes

    • Contributors Conceptualisation: VK, HMB and MH; Methodology: VK, JB and MH; Formal analysis: MH; Investigation: VK and JB; Data curation: MH; Writing—Original draft preparation: VK; Writing—Review and editing: all authors; Visualisation: VK; Supervision: MH; Project administration: VK and MH; Funding acquisition: VK and HMB. Guarantor: MH.This work was completed by THL, YK and FC as employees of Novartis. No payment was given to anyone to produce the manuscript.

    • Funding This work was supported by Novartis.

    • Disclaimer The sponsor was involved in the drafting of the study design, the analysis and interpretation of data, writing the final study report and the decision to submit the manuscript for publication to Archives of Disease in Childhood.

    • Competing interests MH is a full-time employee of Novartis. THL, YK and FC were full-time employees of Novartis at the time of study conduct and eligible to receive Novartis stocks. THL is now employed at Ethris, Planegg, Germany; YK is now a consultant for MYRA Life Science Services, Rosenau, France; and FC is now employed at the University of Pennsylvania, Philadelphia, Pennsylvania, USA. VK and HMB are full-time employees of University Hospital Düsseldorf, Germany, where the trial took place. University Hospital Düsseldorf, Germany, received a fee for conducting the study.

    • Provenance and peer review Not commissioned; externally peer reviewed.

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