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

Research output: Contribution to journalArticle

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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

Fingerprint

valacyclovir
Electronic Nose
Pediatrics
Visual Analog Scale
Parents
Tablets
Glycerol
Cross-Over Studies
In Vitro Techniques

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

In vivo and in vitro palatability testing of a new paediatric formulation of valaciclovir. / Bastiaans, Diane E. T. (Corresponding Author); Immohr, Laura I.; Zeinstra, Gertrude G.; Strik-Albers, Riet; Pein-Hackelbusch, Miriam; van der Flier, Michiel; de Haan, Anton F. J.; Boelens, Jaap Jan; Lankester, Arjan C.; Burger, David M.; Warris, Adilia.

In: British Journal of Clinical Pharmacology, Vol. 83, No. 12, 12.2017, p. 2789-2797.

Research output: Contribution to journalArticle

Bastiaans, DET, Immohr, LI, Zeinstra, GG, Strik-Albers, R, Pein-Hackelbusch, M, van der Flier, M, de Haan, AFJ, Boelens, JJ, Lankester, AC, Burger, DM & Warris, A 2017, 'In vivo and in vitro palatability testing of a new paediatric formulation of valaciclovir', British Journal of Clinical Pharmacology, vol. 83, no. 12, pp. 2789-2797. https://doi.org/10.1111/bcp.13396
Bastiaans DET, Immohr LI, Zeinstra GG, Strik-Albers R, Pein-Hackelbusch M, van der Flier M et al. In vivo and in vitro palatability testing of a new paediatric formulation of valaciclovir. British Journal of Clinical Pharmacology. 2017 Dec;83(12):2789-2797. https://doi.org/10.1111/bcp.13396
Bastiaans, Diane E. T. ; Immohr, Laura I. ; Zeinstra, Gertrude G. ; Strik-Albers, Riet ; Pein-Hackelbusch, Miriam ; van der Flier, Michiel ; de Haan, Anton F. J. ; Boelens, Jaap Jan ; Lankester, Arjan C. ; Burger, David M. ; Warris, Adilia. / In vivo and in vitro palatability testing of a new paediatric formulation of valaciclovir. In: British Journal of Clinical Pharmacology. 2017 ; Vol. 83, No. 12. pp. 2789-2797.
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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.",
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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.

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KW - pharmacotherapy

KW - quality use of medicines

KW - drug development

KW - infectious diseases

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SN - 0306-5251

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ER -