2018
DOI: 10.1111/anae.14318
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A novel, palatable paediatric oral formulation of midazolam: pharmacokinetics, tolerability, efficacy and safety

Abstract: Midazolam is one of many bitter drugs where provision of a suitable oral paediatric formulation, particularly in the pre-anaesthetic setting, remains a challenge. To overcome this problem, a novel chocolate-based tablet formulation has been developed with positive pre-clinical results. To further investigate the potential of this formulation, 150 children aged 3-16 years who were prescribed midazolam as a premedication were randomly assigned to receive 0.5 mg.kg either as the novel formulation or an intravenou… Show more

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Cited by 27 publications
(28 citation statements)
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“…This finding highlights the importance of knowledge on disposition of the metabolites of midazolam. The metabolism and disposition of midazolam and the primary metabolite OHM after oral dosing have been described in preterm neonates and older children, 10,13,14,26,27 but gaps remain for term neonates to children < 1 year old. Most importantly, to the best of our knowledge, data on systemic exposure of OHMG in adults and children after oral dosing are not available.…”
Section: Articlementioning
confidence: 99%
“…This finding highlights the importance of knowledge on disposition of the metabolites of midazolam. The metabolism and disposition of midazolam and the primary metabolite OHM after oral dosing have been described in preterm neonates and older children, 10,13,14,26,27 but gaps remain for term neonates to children < 1 year old. Most importantly, to the best of our knowledge, data on systemic exposure of OHMG in adults and children after oral dosing are not available.…”
Section: Articlementioning
confidence: 99%
“…The off-label administration of intravenous drug formulations orally is another situation where the treatment options for pediatric patients is not optimal and a need for dosage form development is obvious. The administration of intravenous formulations orally is common practice in other countries as well [16,31]. In Australia, chewable chocolate-tasting tablets containing midazolam showed better acceptability compared to the commonly used intravenous formulation in a randomized trial involving children receiving premedication before anesthesia [31].…”
Section: Main Findingsmentioning
confidence: 99%
“…The administration of intravenous formulations orally is common practice in other countries as well [16,31]. In Australia, chewable chocolate-tasting tablets containing midazolam showed better acceptability compared to the commonly used intravenous formulation in a randomized trial involving children receiving premedication before anesthesia [31]. Available formulations and prevailing practices may differ among hospitals and countries.…”
Section: Main Findingsmentioning
confidence: 99%
“…In this issue of Anaesthesia, Salman et al. report on their development of a novel, chocolate‐flavoured oral preparation of midazolam. They included 150 patients aged between 3 and 16 years who had been prescribed oral midazolam in a dose of 0.5 mg.kg −1 .…”
Section: Midazolammentioning
confidence: 99%