Acceptability of different oral formulations in infants and preschool children

Abstract

ObjectiveLiquid 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.MethodsParents 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.Results183 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).ConclusionsAll formulations were well accepted. The tablets were the best accepted formulation; the tablets and syrup the most preferred.Trial Registration numberISRCTN63138435.

Age-appropriate and acceptable paediatric dosage forms: Insights into end-user perceptions, preferences and practices from the Children’s Acceptability of Oral Formulations (CALF) Study

“…Recent studies assessing the acceptability and swallowability of placebo mini-tablets have been a notable emergence in the field, particularly as a dosage form for neonates and infants (Klingmann et al, 2013, Klingmann et al, 2015, Thomson et al, 2009, van Riet-Nales et al, 2013, Kluk et al, 2015. An important objective of 235 the CALF study was to determine acceptability and perceptions of these dosage forms in older children, since very little is reported in the literature.…”

Paediatric Drug Development and Formulation Design—a European Perspective

“…mini-tablets, has already been discussed elsewhere. In summary, we have found that 4-mm uncoated mini-tablets can be used successfully in children from 1 year of age (46). In addition, Klingmann et al showed that smaller 2-mm minitablets can be used in infants from 6 months of age, whereas 2 mm rapidly dissolving mini-tablets can be used as early as in the pre-term age (47,48).…”

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“…This claim is supporting to our result. 9 As shown in Table II, out of total drugs prescribed most common drugs were antihistaminic followed by respiratory drugs, vitamins, analgesics and antibiotics. Antihistaminics were also most commonly prescribed medicines in study done by Cuvillo AD et al 10 Study conducted by Tzimis L et al showed, antipyretics, antibiotic, cough & cold preparations and vitamins were the commonest category of drugs prescribed.…”