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

Autor: Walsh J; Jenny Walsh Consulting Ltd, BioCity Nottingham, Pennyfoot Street, Nottingham, NG1 1GF, United Kingdom. Electronic address: jenny@jennywalshconsulting.com., Ranmal SR; Department of Pharmaceutics, UCL School of Pharmacy, 29-39 Brunswick Square, London, WC1N 1AX, United Kingdom. Electronic address: sejal.ranmal@intractpharma.com., Ernest TB; GSK, Third Avenue, Harlow, Essex, CM19 5AW, United Kingdom. Electronic address: terry.b.ernest@gsk.com., Liu F; Department of Pharmacy, Pharmacology and Postgraduate Medicine, School of Life and Medical Sciences, University of Hertfordshire, Hatfield, AL10 9AB, United Kingdom. Electronic address: f.liu3@herts.ac.uk.
Jazyk: angličtina
Zdroj: International journal of pharmaceutics [Int J Pharm] 2018 Feb 05; Vol. 536 (2), pp. 547-562. Date of Electronic Publication: 2017 Jul 11.
DOI: 10.1016/j.ijpharm.2017.07.017
Abstrakt: 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.
(Copyright © 2017 Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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