Design of methodological tools to assess acceptability of paediatric medicines

Mistry, Punam; Batchelor, Hannah; Tibbins, Carly

doi:10.1016/j.ijpharm.2016.06.098

Cited by 2 publications

(3 citation statements)

References 3 publications

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“…Bespoke PRO tools were developed for this study based on previous methodologies and in consultation with the National Institute for Health Research Children Specialty’s Young Person’s Advisory Group (West Midlands). 8 The young people (aged 11–18 years) reviewed the tools and provided feedback that the tools were age appropriate. The same young people provided feedback on the trial materials including information sheets and how to minimise the burden to participants during the conduct of the study.…”

Section: Methodsmentioning

confidence: 99%

“…They were obtained from S-cool the revision website ( http://www.s-cool.co.uk/gcse/food-technology/systems-and-control/revise-it/sensory-evaluation (accessed December 2015)). Children and young people preferred simple faces and felt that this would be most appropriate for the youngest age group 8 ; anchor phrases were not included on the hedonic scale to keep this tool basic. The Visual Analogue Scale (VAS) included anchor phrases selected by the young persons’ group as the most clear and relevant, 8 these were used at the extreme ends of the continuous scale.…”

Section: Methodsmentioning

confidence: 99%

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Evaluation of patient-reported outcome measurements as a reliable tool to measure acceptability of the taste of paediatric medicines in an inpatient paediatric population

et al. 2018

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ObjectiveTo evaluate the age appropriateness and suitability of patient-reported outcome measures to assess the acceptability of the taste of oral liquid medicines in children.Design and settingAn observational mixed-methods study involving children aged 2–16 years taking oral liquid medicine in paediatric inpatient wards across the West Midlands (UK). Assessment tools included patient-reported scores on the taste of medicines via a five-point Facial Hedonic Scale; a Visual Analogue Scale (VAS); a question, ‘Did you think the medicine tasted OK?’ and researcher observations of facial expressions and behaviours immediately before, during and after administration.Results611 children participated. The percent unable to complete the scales was 7% (n=46) for the VAS; 2% (n=15) for the hedonic scale and 1% (n=7) for the question about taste. Significant correlations (Spearman’s r) were observed between the patient-reported outcome measures: 0.80 and 0.78 for the taste question and hedonic and VAS, respectively, and 0.84 for the hedonic and VAS. Researcher observations demonstrated the ability of the patient to take the medicine as intended but did not provide sensitive measures of taste. 5% of administrations were not taken as intended by the children. Medicines known to have poor taste (clarithromycin and prednisolone) showed mean hedonic and VAS scores of ≥3.5 and >65 mm, respectively.ConclusionsPatient-reported outcome measures correlate with each other and are a useful means to assess the taste (and acceptability) of medicines. Hedonic scales are better understood by children and should be the first choice tool in the assessment of medicines taste.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Evaluation of patient-reported outcome measurements as a reliable tool to measure acceptability of the taste of paediatric medicines in an inpatient paediatric population

et al. 2018

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“…Ideally, evaluation of palatability and acceptability must consider all product factors holistically [6,40]. In this regard, human panels continue to be the gold standard to assess palatability [41]. Previous attempts to predict palatability based on physical properties of excipients resulted in poor predictive power due to the difficulty to consider all contributing factors [26].…”

Section: The Link Between Physical Properties Of Excipients and Palatmentioning

confidence: 99%

Co-Processed Excipients for Dispersible Tablets—Part 2: Patient Acceptability

et al. 2018

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Palatability and patient acceptability are critical attributes of dispersible tablet formulation. Co-processed excipients could provide improved organoleptic profile due to rational choice of excipients and manufacturing techniques. The aim of this study was to identify the most suitable co-processed excipient to use within directly compressible dispersible tablet formulations. Nine excipients, selected based on successful manufacturability, were investigated in a randomised, preference and acceptability testing in 24 healthy adult volunteers. Excipients were classified in order of preference as follows (from most preferred): SmartEx QD100 > F-Melt Type C > F-Melt Type M > MicroceLac > Ludiflash > CombiLac > Pharmaburst 500 > Avicel HFE-102 > Avicel PH-102. Broad differences were identified in terms of acceptability, with SmartEx QD100 being 'very acceptable', F-Melt Type C, F-Melt Type M and MicroceLac being 'acceptable', Ludiflash, CombiLac and Pharmaburst 500 being 'neutral' and Avicel products being 'very unacceptable' based on ratings using five-point hedonic scales. Organoleptic differences were ascribed to different composition and physical properties of excipients, resulting in dissimilar taste and mouth-feel. Excipients with particle size in water larger than 200-250 μm were considered poorly acceptable, which supports the use of this value as a threshold for maximum particle size of dispersible formulation. The most promising co-processed excipients for directly compressible dispersible tablets were successfully identified.

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Design of methodological tools to assess acceptability of paediatric medicines

Cited by 2 publications

References 3 publications

Evaluation of patient-reported outcome measurements as a reliable tool to measure acceptability of the taste of paediatric medicines in an inpatient paediatric population

Evaluation of patient-reported outcome measurements as a reliable tool to measure acceptability of the taste of paediatric medicines in an inpatient paediatric population

Co-Processed Excipients for Dispersible Tablets—Part 2: Patient Acceptability

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