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dc.contributor.authorSalman Sen_US
dc.contributor.authorTang EKYen_US
dc.contributor.authorCheung LCen_US
dc.contributor.authorNguyen MNen_US
dc.contributor.authorSommerfield Den_US
dc.contributor.authorSlevin Len_US
dc.contributor.authorLim LYen_US
dc.contributor.authorvon Ungern Sternberg BSen_US
dc.description.abstractMidazolam 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 either as the novel formulation or an intravenous solution given orally, which is the current standard at our institution. Tolerability was assessed by each child, parent and nurse using a 5-point facial hedonic scale and efficacy was determined as the time to onset of sedation. Blood samples for midazolam and 1-hydroxymidazolam levels were analysed using high-performance liquid chromatography. Population pharmacokinetics were evaluated using non-linear mixed effects modelling. The novel formulation had significantly improved tolerability scores from children, parents and nurses (all p < 0.001). Time to effect was not different between the groups (p = 0.140). The pharmacokinetics of midazolam and 1-hydroxymidazolam were able to be modelled simultaneously. The novel formulation was subject to a higher estimated first-pass metabolism compared with the intravenous solution (8.6% vs. 5.0%) and a significantly lower relative bioavailability of 82.1% (p = 0.013), with no other significant differences. Exposure relative to dose was in the range previously reported for midazolam syrup. We conclude that the novel chocolate-based formulation of midazolam provides improved tolerability while remaining efficacious with suitable pharmacokinetics when used as a premedicant for children.en_US
dc.subjectDrug Compoundingen_US
dc.titleA novel, palatable paediatric oral formulation of midazolam: pharmacokinetics, tolerability, efficacy and safety.en_US
dc.typeJournal Articleen_US
dc.description.affiliatesUniversity of Western Australiaen_US
dc.description.affiliatesCurtin Universityen_US
dc.description.affiliatesPrincess Margaret Hospital for Childrenen_US
dc.type.studyortrialRandomized Controlled Clinical Trial/Controlled Clinical Trialen_US
item.fulltextNo Fulltext-
item.openairetypeJournal Article-
Appears in Collections:Scholarly and Clinical
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