title: Acceptance of uncoated mini-tablets in young children: results from a prospective exploratory cross-over study.
abstract: 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.
  
  
  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.
  
  
  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.
  
  
  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.
authors.affiliation: Department of General Paediatrics and Neonatology, University Children’s Hospital, Düsseldorf, Germany.
authors.forename: Natalie
authors.initials: N
authors.lastname: Spomer
authors.forename: Viviane
authors.initials: V
authors.lastname: Klingmann
authors.forename: Ines
authors.initials: I
authors.lastname: Stoltenberg
authors.forename: Christian
authors.initials: C
authors.lastname: Lerch
authors.forename: Thomas
authors.initials: T
authors.lastname: Meissner
authors.forename: Joerg
authors.initials: J
authors.lastname: Breitkreutz
mesh_terms: D000367:Age Factors; D001294:Attitude to Health; D002626:Chemistry, Pharmaceutical; D002648:Child; D002675:Child, Preschool; D018592:Cross-Over Studies; D003679:Deglutition; D005260:Female; D005947:Glucose; D006801:Humans; D007223:Infant; D008297:Male; D055118:Medication Adherence / Q000523:psychology*; D010316:Particle Size; D019999:Pharmaceutical Solutions; D010865:Pilot Projects; D013607:Tablets
chemical_list: D019999:Pharmaceutical Solutions; D013607:Tablets; D005947:Glucose