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

Diane E T Bastiaans1, Laura I Immohr2, Gertrude G Zeinstra3

  • 1Department of Pharmacy, Radboud University Medical Center, Nijmegen, The Netherlands.

British Journal of Clinical Pharmacology
|August 12, 2017
PubMed

Insights

A new pediatric valaciclovir formulation demonstrated non-inferior palatability compared to the reference. Electronic tongue measurements aided in optimizing taste-masking and study design for this antiviral medication.

Area of Science:

  • Pharmaceutical Sciences
  • Paediatric Medicine
  • Antiviral Drug Development

Background:

  • Valaciclovir is an antiviral medication used in paediatric populations.
  • Improving the palatability of paediatric formulations is crucial for adherence.
  • Taste-masking technologies are essential for developing palatable paediatric medicines.

Purpose of the Study:

  • To assess the palatability of a new paediatric valaciclovir formulation.
  • To compare the non-inferiority of the new formulation against a reference formulation.
  • To explore the utility of electronic tongue measurements in palatability testing.

Main Methods:

  • A randomized, two-period, multicentre, cross-over study was conducted for in vivo palatability testing.
  • Children and parents rated formulation liking using a 100 mm visual analogue scale (VAS).
  • Electronic tongue measurements were employed to support formulation development and palatability assessment.

Main Results:

  • Electronic tongue measurements indicated taste-masking capabilities in developmental formulations.
  • The new paediatric valaciclovir formulation showed a mean VAS score difference of 2.4 mm (children) and -0.9 mm (parents) compared to the reference.
  • These results suggest a preference for the new formulation, although not statistically significant within the tested sample size.

Conclusions:

  • The new paediatric valaciclovir formulation is considered non-inferior in palatability to the reference formulation.
  • Electronic tongue technology successfully supported the optimization of study design and sample size for palatability testing.
  • The findings support the development of improved valaciclovir formulations for paediatric use.
Abstract

Keywords:
drug developmentinfectious diseasespaediatricspharmacotherapyquality use of medicines

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