title: Favorable acceptance of mini-tablets compared with syrup: a randomized controlled trial in infants and preschool children.
abstract: OBJECTIVE
  To evaluate acceptability of 2 mm solid dosage forms (mini-tablets) as an alternative administration modality in young children in comparison with syrup.
  
  
  METHODS
  Three hundred six pediatric in- and outpatients aged 6 months-5 years (51 in each of 6 age groups) were recruited. An open, randomized cross-over study was conducted to compare acceptability and capability to swallow 2 mm uncoated or coated mini-tablets vs 3 mL syrup.
  
  
  RESULTS
  In the overall patient population of 306 children, the acceptability of uncoated mini-tablets was superior to syrup (difference in proportions 14.8%, 95% CI 10.2-19.4; P < .0001). In line with this finding, the level of capability to swallow was higher for uncoated mini-tablets compared with syrup as well (difference in proportions 12.3%, 95% CI 5.4-19.3; P = .0008). All 3 pharmaceutical formulations were well tolerated, and none of the 306 children inhaled or coughed because of the syrup or the uncoated mini-tablet; only 2 of the 306 children (both in age group 0.5-1 year) coughed because of the coated mini-tablet, in both cases without clinical relevance.
  
  
  CONCLUSIONS
  Mini-tablets are a valuable alternative to syrup for children 6 months-6 years of age and are more acceptable compared with liquid formulation. Regulatory bodies such as Food and Drug Administration and European Medicine Agency are encouraged to take our data into account for guideline updates and future drug approval processes.
authors: Department of General Pediatrics, Neonatology, and Pediatric Cardiology, University Children's Hospital Düsseldorf, Düsseldorf, Germany.
authors: Viviane
authors: V
authors: Klingmann
authors: Natalie
authors: N
authors: Spomer
authors: Christian
authors: C
authors: Lerch
authors: Ines
authors: I
authors: Stoltenberg
authors: Cornelia
authors: C
authors: Frömke
authors: Hans Martin
authors: HM
authors: Bosse
authors: Jörg
authors: J
authors: Breitkreutz
authors: Thomas
authors: T
authors: Meissner
mesh_terms: D002675:Child, Preschool; D018592:Cross-Over Studies; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D057240:Patient Preference; D019999:Pharmaceutical Solutions; D013607:Tablets
chemical_list: D019999:Pharmaceutical Solutions; D013607:Tablets
keywords: EMA; European Medicines Agency; WHO; World Health Organization