Storage stability of chocolate-based CDS formulations of midazolam and tramadol as whole tablets, quarter sized tablets and as reconstituted aqueous liquids

Tang, Edith K.Y.; Nguyen, Minh N.; Benington, Leah; Yoo, Okhee; Lim, Lee Yong

doi:10.1016/j.jddst.2021.102574

Cited by 5 publications

(1 citation statement)

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“…The chocolate‐based drug delivery system offers a chewable dosage form preferred by young children [9] and the scored pliable tablet allows accurate division for flexible dosing. Pre‐clinical data have shown the tramadol chocolate‐based drug delivery system tablet to be stable for at least 18 months when wrapped in foil and stored at room temperature [10]. A chocolate‐based drug delivery system midazolam tablet has also been trialled and had a more acceptable taste and non‐inferior bioavailability in children compared with a standard of care midazolam liquid formulation [11].…”

Section: Introductionmentioning

confidence: 99%

A randomised controlled trial of a novel tramadol chewable tablet: pharmacokinetics and tolerability in children

et al. 2022

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Tramadol is a bitter atypical opioid analgesic drug and is prescribed to treat postoperative pain in children. However, in many countries there is no licensed paediatric tramadol formulation available. We have formulated a novel chewable chocolate-based drug delivery system for the administration of tramadol to children. This pilot, single-centre, open-label, randomised clinical study assessed the taste tolerability and comparative population pharmacokinetics of the novel tramadol chewable tablet against a compounded tramadol hydrochloride oral liquid, at a dose of 1 mg.kg -1 . A 5-point facial hedonic scale was used by the children, parents and nurses to assess tolerability. One hundred and forty-one children aged 3-16 years were given tramadol 30 min before general anaesthesia. Blood samples were taken following the induction of anaesthesia and for up to 5 h following tramadol administration. Tramadol and its active metabolite O-desmethyltramadol were analysed using reversed-phase high-performance liquid chromatography. A population pharmacokinetic model was built using non-linear mixed effects modelling. The relative bioavailability for the tablet was 1.25 times higher (95%CI 1.16-1.35) than for tramadol hydrochloride oral liquid, while the absorption rate constant for the tablet was significantly lower (1.97 h -1 vs. 3.34 h -1 , p < 0.001). Larger inter-individual variability in absorption rates were observed with the liquid tramadol. The tramadol chewable tablet was more acceptable in taste to children when assessed by the children, parents and nurses (all p < 0.001). We conclude that the novel tramadol chewable tablet has favourable acceptability and more reliable relative bioavailability in children compared with tramadol hydrochloride oral liquid.

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Section: Introductionmentioning

confidence: 99%