Taste evaluation of a novel midazolam tablet for pediatric patients: In vitro drug dissolution, in vivo animal taste aversion and clinical taste perception profiles

International Journal of Pharmaceutics
Laurence C CheungLee Yong Lim

Abstract

Harmonized methodologies are urgently required for the taste evaluation of novel pediatric medicines. This study utilized in vitro, in vivo and clinical data to evaluate the palatability of a novel midazolam chocolate tablet. In vitro dissolution experiments showed the crushed tablet to release within 5 min 1.68 mg of midazolam into simulated saliva. This translated to a drug level of 0.84 mg/ml in the oral cavity, which would be higher than the midazolam bitterness detection threshold concentration of 0.03 mg/ml determined in a rat 'brief access taste aversion' (BATA) model. The visual analogue scale scores of patients aged 4-16 years prescribed with midazolam pre-surgery showed a clear preference for the midazolam chocolate tablets (3.35 ± 1.04, n = 20) compared to the control midazolam solution (1.47 ± 0.62, n = 17). The clinical data was in agreement with the in vivo rodent data in showing the novel chocolate tablet matrix to be effective at taste-masking the bitter midazolam.

Citations

Jul 9, 2020·Pharmaceutics·Ángela Aguilar-de-LeyvaIsidoro Caraballo
Dec 5, 2020·Pharmaceutical Development and Technology·Marina Delanni Vitória GuedesIrene Clemes Kulkamp Guerreiro
Feb 2, 2021·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Joseph AliPavel Gershkovich
Mar 20, 2021·Journal of Paediatrics and Child Health·Shannon TruongLee Yong Lim
Mar 23, 2019·Molecular Pharmaceutics·Alexander KeeleyCatherine Tuleu
Nov 24, 2021·International Journal of Clinical Pharmacy·Andy JeonBritta S von Ungern-Sternberg

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