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What is already known on this subject
Oral medicines are frequently administered to infants and preschool children as a liquid formulation.
Liquid formulations may have disadvantages, such as a bad taste or refrigerated storage conditions.
Small tablets can be used to administer medicines to young children.
What this study adds
Minitablets (4 mm diameter) were the most acceptable formulation to healthy Dutch infants and preschool children.
Both parents and children preferred the minitablets and syrups to the suspensions and powders.
Introduction
For decades, oral liquid dosage forms, such as syrups and suspensions, have been considered as the favourable type of dosage form in which to administer medicines to young children. 1 2 However, oral liquid medicines may have disadvantages, such as a bad taste, portability problems or refrigerated storage conditions. 3-6 Therefore, WHO currently favours that young children, particularly in developing countries, be treated with oral solid medicines. 7
Oral liquid medicines are more commonly available for use in infants and preschool children than oral solid (flexible) medicines, such as powders or orodispersible tablets. 8 Small-sized tablets, also referred to as minitablets, have been identified as a new type of oral solid dosage form in which to administer medicines to young children. However, only few of such tablets have been authorised for children below 4 years of age. 3 6 9-11 Nevertheless, small tablets have been widely used in this age group as food supplements, for example, 4 mm sodium fluoride tablets for caries prevention, or 4 mm vitamin AD tablets. 12-16
The selection of an oral dosage form and the pharmaceutical aspects of the formulation, such as the palatability of an oral suspension or the size of a tablet, are important factors in the overall acceptability of an oral paediatric medicine. 6 10 As adequate child and parent acceptability are prerequisites for good drug adherence, paediatric treatment outcomes may be enhanced by a careful selection of the formulation including the type of the dosage form. Therefore, 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
Study design
A randomised cross-over trial was performed in six Dutch preschool preventive healthcare clinics in Beusichem, Beesd, Culemborg (2 clinics),...