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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.
- Source :
-
International Journal of Pharmaceutics . Jan2018, Vol. 535 Issue 1/2, p194-200. 7p. - Publication Year :
- 2018
-
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. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 03785173
- Volume :
- 535
- Issue :
- 1/2
- Database :
- Academic Search Index
- Journal :
- International Journal of Pharmaceutics
- Publication Type :
- Academic Journal
- Accession number :
- 127075489
- Full Text :
- https://doi.org/10.1016/j.ijpharm.2017.10.060