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. Liu F, Ranmal S, Batchelor HK, Orlu-Gul M, Ernest TB, Thomas IW, Flanagan T, Tuleu C., Patient-centred pharmaceutical design to improve acceptability of medicines: similarities and differences in paediatric and geriatric populations. Drugs. 2014, 74:1871-8 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4210646/pdf/40265_2014_Article_297.pdf
  2. 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.
  3. 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 (fionaobrien@rcsi.ie) and David Harris (david.harris@merck.com)

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