Patient acceptability, safety and access: A balancing act for selecting age-appropriate oral dosage forms for paediatric and geriatric populations

Jennifer Walsh, Sejal R. Ranmal, Terry B. Ernest, Fang Liu

Research output: Contribution to journalArticlepeer-review

34 Citations (Scopus)
43 Downloads (Pure)

Abstract

The selection and design of age-appropriate formulations intended for use in paediatric and geriatric patients are dependent on multiple factors affecting patient acceptability, safety and access. The development of an economic and effective product relies on a balanced consideration of the risks and benefits of these factors. This review provides a comprehensive and up-to-date analysis of oral dosage forms considering key aspects of formulation design including dosage considerations, ease of use, tolerability and safety, manufacturing complexity, stability, supply and cost. Patient acceptability has been examined utilising an evidence-based approach to evaluate regulatory guidance and literature. Safety considerations including excipients and potential risk of administration errors of the different dosage forms are also discussed, together with possible manufacturing and supply challenges. Age appropriate drug product design should consider and compare i) acceptability ii) safety and iii) access, although it is important to recognise that these factors must be balanced against each other, and in some situations a compromise may need to be reached when selecting an age-appropriate formulation.
Original languageEnglish
Pages (from-to)547-562
Number of pages16
JournalInternational Journal of Pharmaceutics
Volume536
Issue number2
Early online date11 Jul 2017
DOIs
Publication statusPublished - 5 Feb 2018

Keywords

  • Acceptability
  • Access
  • Drug product design
  • Formulation
  • Geriatric
  • Manufacture
  • Oral
  • Pediatric

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