title: Formulation approaches to pediatric oral drug delivery: benefits and limitations of current platforms.
abstract: BACKGROUND
  Most conventional drug delivery systems are not acceptable for pediatric patients as they differ in their developmental status and dosing requirements from other subsets of the population. Technology platforms are required to aid the development of age-appropriate medicines to maximize patient acceptability while maintaining safety, efficacy, accessibility and affordability.
  
  
  METHODS
  The current approaches and novel developments in the field of age-appropriate drug delivery for pediatric patients are critically discussed including patient-centric formulations, administration devices and packaging systems.
  
  
  CONCLUSIONS
  Despite the incentives provided by recent regulatory modifications and the efforts of formulation scientists, there is still a need for implementation of pharmaceutical technologies that enable the manufacture of licensed age-appropriate formulations. Harmonization of endeavors from regulators, industry and academia by sharing learning associated with data obtained from pediatric investigation plans, product development pathways and scientific projects would be the way forward to speed up bench-to-market age appropriate formulation development. A collaborative approach will benefit not only pediatrics, but other patient populations such as geriatrics would also benefit from an accelerated patient-centric approach to drug delivery.
authors.affiliation: a 1 University College London, School of Pharmacy, Department of Pharmaceutics , 29-39 Brunswick Square, London WC1N 1AX, UK felipe.lopez.13@ucl.ac.uk.
authors.forename: Felipe L
authors.initials: FL
authors.lastname: Lopez
authors.affiliation: b 2 GlaxoSmithKline, Product Development , New Frontiers Science Park, Third Avenue, Harlow, Essex CM19 5AW, UK.
authors.forename: Terry B
authors.initials: TB
authors.lastname: Ernest
authors.affiliation: a 1 University College London, School of Pharmacy, Department of Pharmaceutics , 29-39 Brunswick Square, London WC1N 1AX, UK felipe.lopez.13@ucl.ac.uk.
authors.forename: Catherine
authors.initials: C
authors.lastname: Tuleu
authors.affiliation: a 1 University College London, School of Pharmacy, Department of Pharmaceutics , 29-39 Brunswick Square, London WC1N 1AX, UK felipe.lopez.13@ucl.ac.uk.
authors.forename: Mine Orlu
authors.initials: MO
authors.lastname: Gul
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods*; D002648:Child; D016503:Drug Delivery Systems; D006801:Humans; D010372:Pediatrics; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*; D013678:Technology, Pharmaceutical
chemical_list: D004364:Pharmaceutical Preparations
keywords: acceptability; age-appropriate; formulation development; oral drug delivery system; pediatric drug delivery; technology platform