The purpose of the workstream is to provide guidance to industry, regulators and academic researchers of the age-appropriateness of different pharmaceutical dosage forms for use in children.

These include:

  • The development and evaluation of medicines for marketing authorisations
  • The use of modifications to the dosage form (Extemporaneous Preparations or compounding; manipulation at the point of administration and Industry Verified Preparations and manipulations) in practice

Our current priorities are:

  • Dosage form acceptability, safety, efficacy and dose flexibility
  • Modified release formulations
  • Routes of administration
  • Food/drink effects on administration of medicines
  • Safety and efficacy of co-administration
  • Manufacturing challenges in developing paediatric formulations

Our achievements to date include:

  1. O'Brien F, Clapham D, Krysiak K, et al. Int J Mol Sci. 2019;20(11):2688. Published 2019 May 31. doi:10.3390/ijms20112688 Making Medicines Baby Size: The Challenges in Bridging the Formulation Gap in Neonatal Medicine
  2. Walsh J, Ranmal SR, Ernest TB, Liu F. Int J Pharm. 2018 Feb 5;536(2):547-562. doi: 10.1016/j.ijpharm.2017.07.017 Patient acceptability, safety and access: A balancing act for selecting age-appropriate oral dosage forms for paediatric and geriatric populations
  3. Ranmal SR, O'Brien F, Lopez F, Ruiz F, Orlu M, Tuleu C, Walsh J, Liu F.Drug Discov Today. 2018 Apr;23(4):830-847. doi: 10.1016/j.drudis.2018.01.038. Methodologies for assessing the acceptability of oral formulations among children and older adults: a systematic review
  4. Liu F, Ranmal S, Batchelor HK, Orlu-Gul M, Ernest TB, Thomas IW, Flanagan T, Kendall R, Tuleu C, Formulation factors affecting acceptability of oral medicines in children. Int J Pharm. 2015, 492:341-3.
  5. Liu F, Ranmal S, Batchelor HK, Orlu-Gul M, Ernest TB, Thomas IW, Flanagan T, Tuleu C. Drugs. 2014 Oct;74(16):1871-1889. doi: 10.1007/s40265-014-0297-2. Patient-Centered Pharmaceutical Design to Improve Acceptability of Medicines: Similarities and Differences in Paediatric and Geriatric Populations
  6. Presentation at EuPFI annual meeting 2014: Formulation factors affecting acceptability of oral medicines in children and older adults

If you are interested in joining or would like further information please contact Fiona O'Brien ( and David Harris (

Print Friendly, PDF & Email