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

Diane E. T. Bastiaans; 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

doi:10.1111/bcp.13396

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

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

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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 language	English
Pages (from-to)	2789-2797
Number of pages	9
Journal	British Journal of Clinical Pharmacology
Volume	83
Issue number	12
Early online date	20 Sept 2017
DOIs	https://doi.org/10.1111/bcp.13396
Publication status	Published - Dec 2017

Bibliographical note

Acknowledgments
The authors want to thank all of the children and their parents for participation in the palatability assessment. They also want to thank Marieke Roskam-Kwint for assistance in the performance of the palatability assessment.

Keywords

paediatrics
pharmacotherapy
quality use of medicines
drug development
infectious diseases

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1111/bcp.13396Licence: CC BY-NC

In vivo and in vitro palatability testing of a new paediatric formulation of valaciclovir
© 2017 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. https://creativecommons.org/licenses/by-nc/4.0/
Final published version, 582 KBLicence: CC BY
Early Online: In vivo and in vitro palatability testing of a new paediatric formulation of valaciclovir
© 2017 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. https://creativecommons.org/licenses/by-nc/4.0/
Final published version, 369 KBLicence: CC BY-NC

Cite this

Bastiaans, D. E. T., Immohr, L. I., Zeinstra, G. G., Strik-Albers, R., Pein-Hackelbusch, M., van der Flier, M., de Haan, A. F. J., Boelens, J. J., Lankester, A. C., Burger, D. 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

@article{3eb094b34ba049bcbe198ae775a7fbba,

title = "In vivo and in vitro palatability testing of a new paediatric formulation of valaciclovir",

abstract = "AimThe 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.MethodsIn 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.ResultsThe 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.ConclusionThe 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.",

keywords = "paediatrics, pharmacotherapy, quality use of medicines, drug development, infectious diseases",

author = "Bastiaans, {Diane E. T.} and Immohr, {Laura I.} and Zeinstra, {Gertrude G.} and Riet Strik-Albers and Miriam Pein-Hackelbusch and {van der Flier}, Michiel and {de Haan}, {Anton F. J.} and Boelens, {Jaap Jan} and Lankester, {Arjan C.} and Burger, {David M.} and Adilia Warris",

note = "Acknowledgments The authors want to thank all of the children and their parents for participation in the palatability assessment. They also want to thank Marieke Roskam-Kwint for assistance in the performance of the palatability assessment. ",

year = "2017",

month = dec,

doi = "10.1111/bcp.13396",

language = "English",

volume = "83",

pages = "2789--2797",

journal = "British Journal of Clinical Pharmacology",

issn = "0306-5251",

publisher = "Wiley-Blackwell ",

number = "12",

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TY - JOUR

T1 - In vivo and in vitro palatability testing of a new paediatric formulation of valaciclovir

AU - Bastiaans, Diane E. T.

AU - Immohr, Laura I.

AU - Zeinstra, Gertrude G.

AU - Strik-Albers, Riet

AU - Pein-Hackelbusch, Miriam

AU - van der Flier, Michiel

AU - de Haan, Anton F. J.

AU - Boelens, Jaap Jan

AU - Lankester, Arjan C.

AU - Burger, David M.

AU - Warris, Adilia

N1 - Acknowledgments The authors want to thank all of the children and their parents for participation in the palatability assessment. They also want to thank Marieke Roskam-Kwint for assistance in the performance of the palatability assessment.

PY - 2017/12

Y1 - 2017/12

N2 - AimThe 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.MethodsIn 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.ResultsThe 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.ConclusionThe 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.

AB - AimThe 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.MethodsIn 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.ResultsThe 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.ConclusionThe 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.

KW - paediatrics

KW - pharmacotherapy

KW - quality use of medicines

KW - drug development

KW - infectious diseases

U2 - 10.1111/bcp.13396

DO - 10.1111/bcp.13396

M3 - Article

C2 - 28800385

SN - 0306-5251

VL - 83

SP - 2789

EP - 2797

JO - British Journal of Clinical Pharmacology

JF - British Journal of Clinical Pharmacology

IS - 12

ER -

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

Abstract

Bibliographical note

Keywords

UN SDGs

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