title: Acceptability of Mini-Tablets in Young Children: Results from Three Prospective Cross-over Studies.
abstract: To ensure optimal, reliable treatment, it is necessary to investigate the efficacy, safety and the optimal dose of drug substances and to develop suitable age-specific pharmaceutical formulations for the different paediatric age groups due to a lack of evidence-based therapeutic options for children. While WHO recommends the use of solid dosage forms in general, European Medicines Agency (EMA) requires evidence for the suitability of these dosage forms in the targeted age group. This review aims to summarize and discuss the data obtained in acceptability studies on the suitability of coated and uncoated mini-tablets in children of different ages in comparison to a sweet syrup considered as gold standard. The predefined outcome parameters 'acceptability' and 'capability to swallow' of the two different mini-tablet formulations (uncoated and film-coated) were statistically significantly higher than that of the syrup.
authors.affiliation: Department of General Paediatrics, Neonatology, and Paediatric Cardiology, University Children's Hospital Duesseldorf, Moorenstrasse 5, 40225, Duesseldorf, Germany. viviane.klingmann@med.uni-duesseldorf.de.
authors.forename: Viviane
authors.initials: V
authors.lastname: Klingmann
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods; D002986:Clinical Trials as Topic; D018592:Cross-Over Studies; D004304:Dosage Forms; D006801:Humans; D010342:Patient Acceptance of Health Care / Q000523:psychology*; D010372:Pediatrics; D010865:Pilot Projects; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic; D013607:Tablets / Q000627:therapeutic use*
chemical_list: D004304:Dosage Forms; D013607:Tablets
keywords: acceptability; drug administration; mini-tablets; paediatric drug dosage forms; swallowability