Acceptability of different oral formulations in infants and preschool children

• Published in: Archives of disease in childhood Vol. 98; no. 9; pp. 725 - 731
• Main Authors: van Riet-Nales, Diana A, de Neef, Barbara J, Schobben, Alfred F A M, Ferreira, José A, Egberts, Toine C G, Rademaker, Catharine M A
• Format: Journal Article
• Language: English
• Published: London BMJ Publishing Group Ltd and Royal College of Paediatrics and Child Health 01.09.2013; BMJ Publishing Group; BMJ Publishing Group Ltd; BMJ Publishing Group LTD
• Series: Original article
• Subjects: Administration, Oral; Biological and medical sciences; Child; Child Development; Child health; Child, Preschool; Children; Cross-Over Studies; Developmental Delays; Dosage and administration; Dosage Form; Drug Therapy; Eating Disorders; Female; General aspects; Health aspects; Humans; Infant; Infants; Male; Medical sciences; Medicine; Miscellaneous; Netherlands; Observation; Oral drugs; Oral medication; Outcomes of Treatment; Parent; Parents; Patient Acceptance; Patient Preference; Pharmaceutical Solutions - administration & dosage; Physical Development; Powders - administration & dosage; Preschool children; Prevention and actions; Public health. Hygiene; Public health. Hygiene-occupational medicine; Suspension; Suspensions - administration & dosage; Tablets - administration & dosage; Taste; Water; Young Children; Netherlands; Human; Preschool age; Pediatrics; Acceptance; Formulation; Oral administration; Dosage form; Infant; Child; Public health; Medicine; Patient Acceptance; Dosage Form; Parent
• ISSN: 0003-9888; 1468-2044
• DOI: 10.1136/archdischild-2012-303303

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.