In vivo and in vitro palatability testing of a new paediatric formulation of valaciclovir

Diane E. T. Bastiaans (Corresponding Author), Laura I. Immohr, Gertrude G. Zeinstra, Riet Strik-Albers, Miriam Pein-Hackelbusch, Michiel van der Flier, Anton F. J. de Haan, Jaap Jan Boelens, Arjan C. Lankester, David M. Burger, Adilia Warris

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Abstract

Aim

The palatability of a new paediatric formulation of valaciclovir was assessed in children and their parents: non-inferiority of the new paediatric formulation (test formulation) compared to the reference formulation was investigated.
Methods

In vivo palatability testing was performed in a randomized, two-period, multicentre, cross-over study. Children and their parents scored the liking of the new paediatric valaciclovir formulation and the reference formulation on a 100 mm visual analogue scale (VAS). To support formulation development and palatability testing, electronic tongue measurements were applied.
Results

The electronic tongue measurement indicated taste-masking capabilities for three different formulations in the developmental phase. A glycerol-based formulation was further tested and compared to the reference formulation prepared out of crushed and suspended tablets. The mean difference (95%CI) in VAS scores between both formulations, as indicated by the children (n=20), was 2.4 (-8.5, 13) mm, in favour of the new paediatric valaciclovir formulation. The mean (95%CI) difference in VAS scores indicated by the parents (n=20) was -0.9 (-12, 9.8) mm.
Conclusion

The palatability of the new paediatric valaciclovir formulation was considered non-inferior to the reference formulation prepared out of crushed tablets. We were able to optimize the study design and number of children to be included in the palatability testing by using electronic tongue measurements.
Original languageEnglish
Pages (from-to)2789-2797
Number of pages9
JournalBritish Journal of Clinical Pharmacology
Volume83
Issue number12
Early online date20 Sep 2017
DOIs
Publication statusPublished - Dec 2017

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Keywords

  • paediatrics
  • pharmacotherapy
  • quality use of medicines
  • drug development
  • infectious diseases

Cite this

Bastiaans, D. E. T., Immohr, L. I., Zeinstra, G. G., Strik-Albers, R., Pein-Hackelbusch, M., van der Flier, M., ... Warris, A. (2017). In vivo and in vitro palatability testing of a new paediatric formulation of valaciclovir. British Journal of Clinical Pharmacology, 83(12), 2789-2797. https://doi.org/10.1111/bcp.13396