Acceptability of different oral formulations in infants and preschool children
Identifieur interne : 000427 ( Main/Exploration ); précédent : 000426; suivant : 000428Acceptability of different oral formulations in infants and preschool children
Auteurs : Diana A. Van Riet-Nales [Pays-Bas] ; Barbara J. De Neef [Pays-Bas] ; Alfred F A M. Schobben [Pays-Bas] ; José A. Ferreira [Pays-Bas] ; Toine C G. Egberts [Pays-Bas] ; Catharine M A. Rademaker [Pays-Bas]Source :
- Archives of Disease in Childhood [ 0003-9888 ] ; 2013-09.
Abstract
Objective Liquid medicines are easy to swallow. However, they may have disadvantages, such as a bad taste or refrigerated storage conditions. These disadvantages may be avoided by the use of oral solid medicines, such as powders or tablets. The aim of this study was to investigate the acceptability of and preference among four oral formulations in domiciliary infants and preschool children in The Netherlands. Methods Parents administered four oral placebo dosage forms that were aimed at a neutral taste, at home, to their child (1–4 years of age) twice on one day following a randomised cross-over design: small (4 mm) tablet, powder, suspension and syrup. They were asked to report the child's acceptability by a score on a 10 cm visual analogue scale (VAS score) and by the result of the intake. At the end of the study, they were asked to report the preference of the child and themselves. Results 183 children were included and 148 children were evaluated. The data revealed a period/cross-over effect. The estimate of the mean VAS score was significantly higher for the tablet than for the suspension (tablet 9.39/9.01; powder 8.84/8.20, suspension 8.26/7.90, syrup 8.35/8.19; data day 1/all days). The estimate of the mean number of intakes fully swallowed was significantly higher for the tablet than for the other formulations (all p values <0.05). Children and parents preferred the tablet and syrup over the suspension and the suspension over the powder (all p values <0.05). Conclusions All formulations were well accepted. The tablets were the best accepted formulation; the tablets and syrup the most preferred. Trial Registration number ISRCTN63138435.
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DOI: 10.1136/archdischild-2012-303303
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Ferreira</name><affiliation wicri:level="1"><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>National Institute for Public Health and the Environment, Department of Statistics, Modelling and Data Management, Bilthoven</wicri:regionArea><wicri:noRegion>Bilthoven</wicri:noRegion></affiliation></author><author><name sortKey="Egberts, Toine C G" sort="Egberts, Toine C G" uniqKey="Egberts T" first="Toine C G" last="Egberts">Toine C G. Egberts</name><affiliation wicri:level="4"><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Utrecht University, Faculty of Science, Utrecht Institute for Pharmaceutical Sciences, Department of Pharmacoepidemiology and Clinical Pharmacology, Utrecht</wicri:regionArea><placeName><settlement type="city">Utrecht</settlement><region nuts="2" type="province">Utrecht (province)</region></placeName><orgName type="university">Université d'Utrecht</orgName></affiliation><affiliation wicri:level="3"><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>University Medical Centre Utrecht, Department of Clinical Pharmacy, Utrecht</wicri:regionArea><placeName><settlement type="city">Utrecht</settlement><region nuts="2" type="province">Utrecht (province)</region></placeName></affiliation></author><author><name sortKey="Rademaker, Catharine M A" sort="Rademaker, Catharine M A" uniqKey="Rademaker C" first="Catharine M A" last="Rademaker">Catharine M A. 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However, they may have disadvantages, such as a bad taste or refrigerated storage conditions. These disadvantages may be avoided by the use of oral solid medicines, such as powders or tablets. The aim of this study was to investigate the acceptability of and preference among four oral formulations in domiciliary infants and preschool children in The Netherlands. Methods Parents administered four oral placebo dosage forms that were aimed at a neutral taste, at home, to their child (1–4 years of age) twice on one day following a randomised cross-over design: small (4 mm) tablet, powder, suspension and syrup. They were asked to report the child's acceptability by a score on a 10 cm visual analogue scale (VAS score) and by the result of the intake. At the end of the study, they were asked to report the preference of the child and themselves. Results 183 children were included and 148 children were evaluated. The data revealed a period/cross-over effect. The estimate of the mean VAS score was significantly higher for the tablet than for the suspension (tablet 9.39/9.01; powder 8.84/8.20, suspension 8.26/7.90, syrup 8.35/8.19; data day 1/all days). The estimate of the mean number of intakes fully swallowed was significantly higher for the tablet than for the other formulations (all p values <0.05). Children and parents preferred the tablet and syrup over the suspension and the suspension over the powder (all p values <0.05). Conclusions All formulations were well accepted. The tablets were the best accepted formulation; the tablets and syrup the most preferred. Trial Registration number ISRCTN63138435.</div></front></TEI><affiliations><list><country><li>Pays-Bas</li></country><region><li>Utrecht (province)</li></region><settlement><li>Utrecht</li></settlement><orgName><li>Université d'Utrecht</li></orgName></list><tree><country name="Pays-Bas"><region name="Utrecht (province)"><name sortKey="Van Riet Nales, Diana A" sort="Van Riet Nales, Diana A" uniqKey="Van Riet Nales D" first="Diana A" last="Van Riet-Nales">Diana A. Van Riet-Nales</name></region><name sortKey="De Neef, Barbara J" sort="De Neef, Barbara J" uniqKey="De Neef B" first="Barbara J" last="De Neef">Barbara J. De Neef</name><name sortKey="Egberts, Toine C G" sort="Egberts, Toine C G" uniqKey="Egberts T" first="Toine C G" last="Egberts">Toine C G. Egberts</name><name sortKey="Egberts, Toine C G" sort="Egberts, Toine C G" uniqKey="Egberts T" first="Toine C G" last="Egberts">Toine C G. Egberts</name><name sortKey="Ferreira, Jose A" sort="Ferreira, Jose A" uniqKey="Ferreira J" first="José A" last="Ferreira">José A. Ferreira</name><name sortKey="Rademaker, Catharine M A" sort="Rademaker, Catharine M A" uniqKey="Rademaker C" first="Catharine M A" last="Rademaker">Catharine M A. Rademaker</name><name sortKey="Schobben, Alfred F A M" sort="Schobben, Alfred F A M" uniqKey="Schobben A" first="Alfred F A M" last="Schobben">Alfred F A M. Schobben</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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