Acceptance of uncoated mini-tablets in young children: results from a prospective exploratory cross-over study

作者：Spomer Natalie; Klingmann Viviane; Stoltenberg Ines; Lerch Christian; Meissner Thomas; Breitkreutz Joerg^*

来源：Archives of Disease in Childhood, 2012, 97(3): 283-286.

DOI：10.1136/archdischild-2011-300958

Objective To explore the acceptance of uncoated drug-free mini-tablets 2 mm in diameter in children aged 0.5-6 years and their ability to swallow the mini-tablets. %26lt;br%26gt;Methods 60 children aged 0.5-6 years (10 subjects per year of life) were enrolled in our prospective, open random, two-way cross-over exploratory pilot study. The children were administered either an uncoated drug-free mini-tablet 2 mm in diameter with a beverage of their choice or 3 ml of glucose syrup 15% followed by the other formulation. Deglutition was visually assessed for the two different dosage forms using a predefined criteria list. %26lt;br%26gt;Results The study hypothesis was that children would accept the liquid formulation better than the solid mini-tablets. Surprisingly, the authors found that the acceptance of the mini-tablets, defined as immediate swallowing or chewing first with subsequent swallowing, was higher or at least equal to that of the syrup. Very young children (6-12 months) were fully capable of swallowing the mini-tablets and may even accept them better than the sweet liquid formulation. Some children aged between 2 and 4 years chewed the tablets before swallowing, but still accepted them quite well. The acceptance rate of the mini-tablets in the different age groups was much higher than expected. %26lt;br%26gt;Conclusions Uncoated mini-tablets seem to be a very promising alternative to liquid formulations and could be used at an earlier age in paediatric drug therapy than previously anticipated.

• 出版日期2012-3