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

    Access Status
    Fulltext not available
    Authors
    Cheung, Laurence
    Nguyen, M.
    Tang, E.
    von Ungern Sternberg, B.
    Salman, S.
    Tuleu, C.
    Mohamed Ahmed, A.
    Soto, J.
    Lim, L.
    Date
    2018
    Type
    Journal Article
    
    Metadata
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    Citation
    Cheung, L. and Nguyen, M. and Tang, E. and von Ungern Sternberg, B. and Salman, S. and Tuleu, C. and Mohamed Ahmed, A. et al. 2018. 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. 535 (1-2): pp. 194-200.
    Source Title
    International Journal of Pharmaceutics
    DOI
    10.1016/j.ijpharm.2017.10.060
    ISSN
    0378-5173
    School
    School of Pharmacy and Biomedical Sciences
    URI
    http://hdl.handle.net/20.500.11937/67975
    Collection
    • Curtin Research Publications
    Abstract

    © 2017 Elsevier B.V. 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.

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