title: Playing hide and seek with poorly tasting paediatric medicines: do not forget the excipients.
abstract: The development of paediatric medicines can be challenging since this is a diverse patient population with specific needs. For example, the toxicity of excipients may differ in children compared to adults and children have different taste preferences. Acceptable palatability of oral paediatric medicinal products is of great importance to facilitate patient adherence. This has been recognised by regulatory authorities and so is becoming a key aspect of paediatric pharmaceutical development studies. Many active pharmaceutical ingredients (APIs) have aversive taste characteristics and so it is necessary to utilise taste masking techniques to improve the palatability of paediatric oral formulations. The aim of this review is to provide an overview of different approaches to taste masking APIs in paediatric oral dosage forms, with a focus on the tolerability of excipients used. In addition, where possible, the provision of examples of some marketed products is made.
authors.affiliation: Jenny Walsh Consulting Ltd, BioCity Nottingham, Pennyfoot Street, Nottingham NG1 1GF, United Kingdom. Electronic address: jenny@jennywalshconsulting.com.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Walsh
authors.affiliation: Drug Product Development, Pfizer Ltd, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom. Electronic address: anne.cram@pfizer.com.
authors.forename: Anne
authors.initials: A
authors.lastname: Cram
authors.affiliation: Institute of Pharmaceutics and Biopharmaceutics, Heinrich-Heine-University Duesseldorf, Building 26.22, Universitaetsstrasse 1,40225 Duesseldorf, Germany.
authors.forename: Katharina
authors.initials: K
authors.lastname: Woertz
authors.affiliation: Institute of Pharmaceutics and Biopharmaceutics, Heinrich-Heine-University Duesseldorf, Building 26.22, Universitaetsstrasse 1,40225 Duesseldorf, Germany. Electronic address: joerg.breitkreutz@uni-duesseldorf.de.
authors.forename: Joerg
authors.initials: J
authors.lastname: Breitkreutz
authors.affiliation: Novartis Pharma AG, Postfach, CH-4002 Basel, Switzerland. Electronic address: gesine.winzenburg@novartis.com.
authors.forename: Gesine
authors.initials: G
authors.lastname: Winzenburg
authors.affiliation: Novartis Pharma AG, Postfach, CH-4002 Basel, Switzerland. Electronic address: roy.turner@novartis.com.
authors.forename: Roy
authors.initials: R
authors.lastname: Turner
authors.affiliation: Centre for Paediatric Pharmacy Research, UCL School of Pharmacy, 29-39 Brunswick Square, London WC1N 1AX, United Kingdom. Electronic address: c.tuleu@ucl.ac.uk.
authors.forename: Catherine
authors.initials: C
authors.lastname: Tuleu
mesh_terms: D002626:Chemistry, Pharmaceutical; D002648:Child; D005079:Excipients / Q000008:administration & dosage* / Q000633:toxicity; D005421:Flavoring Agents / Q000008:administration & dosage / Q000633:toxicity; D006801:Humans; D010372:Pediatrics; D004364:Pharmaceutical Preparations / Q000008:administration & dosage; D013649:Taste / Q000187:drug effects*
chemical_list: D005079:Excipients; D005421:Flavoring Agents; D004364:Pharmaceutical Preparations
keywords: Dosage form; Excipient; Formulation; Paediatric; Palatability; Taste masking