Details

Autor(en) / Beteiligte

• Cheung, Laurence C.
• Nguyen, Minh
• Tang, Edith
• von Ungern Sternberg, Britta S.
• Salman, Sam
• Tuleu, Catherine
• Mohamed Ahmed, Abeer H.A.
• Soto, Jessica
• Lim, Lee Yong

Titel

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

Ist Teil von

• International journal of pharmaceutics, 2018-01, Vol.535 (1-2), p.194-200

Ort / Verlag

Netherlands: Elsevier B.V

Erscheinungsjahr

2018

Quelle

Alma/SFX Local Collection

Beschreibungen/Notizen

• [Display omitted] [Display omitted] 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.