title: Safe and effective pharmacotherapy in infants and preschool children: importance of formulation aspects.
abstract: Safe and effective paediatric pharmacotherapy requires careful evaluation of the type of drug substance, the necessary dose and the age-appropriateness of the formulation. Generally, the younger the child, the more the attention that is required. For decades, there has been a general lack of (authorised) formulations that children are able to and willing to take. Moreover, little was known on the impact of pharmaceutical aspects on the age-appropriateness of a paediatric medicine. As a result of legislative incentives, such knowledge is increasingly becoming available. It has become evident that rapidly dissolving tablets with a diameter of 2 mm (mini-tablets) can be used in preterm neonates and non-rapidly dissolving 2 mm mini-tablets in infants from 6 months of age. In addition, uncoated 4 mm mini-tablets can be used in infants from the age of 1 year. Also, there is some evidence that children prefer mini-tablets over a powder, suspension or syrup. Other novel types of age-appropriate oral formulations such as orodispersible films may further add to the treatment possibilities. This review provides an overview of the current knowledge on oral formulations for infants and preschool children, the advantages and disadvantages of the different types of dosage forms and the age groups by which these can likely be used.
authors.affiliation: Chemical Pharmaceutical Assessment (CFB), Medicines Evaluation Board in the Netherlands, Utrecht, The Netherlands Department of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Faculty of Science, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht, The Netherlands.
authors.forename: Diana A
authors.initials: DA
authors.lastname: van Riet-Nales
authors.affiliation: Chemical Pharmaceutical Assessment (CFB), Medicines Evaluation Board in the Netherlands, Utrecht, The Netherlands Department of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Faculty of Science, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht, The Netherlands.
authors.forename: Alfred F A M
authors.initials: AF
authors.lastname: Schobben
authors.affiliation: Department of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Faculty of Science, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht, The Netherlands Department of Clinical Pharmacy, University Medical Centre Utrecht, Utrecht, The Netherlands.
authors.forename: Herman
authors.initials: H
authors.lastname: Vromans
authors.affiliation: Department of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Faculty of Science, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht, The Netherlands Department of Clinical Pharmacy, University Medical Centre Utrecht, Utrecht, The Netherlands.
authors.forename: Toine C G
authors.initials: TC
authors.lastname: Egberts
authors.affiliation: Department of Clinical Pharmacy, University Medical Centre Utrecht, Utrecht, The Netherlands.
authors.forename: Carin M A
authors.initials: CM
authors.lastname: Rademaker
mesh_terms: D000284:Administration, Oral; D000367:Age Factors; D002626:Chemistry, Pharmaceutical; D002675:Child, Preschool; D004304:Dosage Forms; D004358:Drug Therapy / Q000379:methods / Q000592:standards*; D005079:Excipients; D006801:Humans; D007223:Infant; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*; D012996:Solutions; D013607:Tablets
chemical_list: D004304:Dosage Forms; D005079:Excipients; D004364:Pharmaceutical Preparations; D012996:Solutions; D013607:Tablets
keywords: administration, oral; child; formulation; mini-tablet; tehnology, pharmaceutical