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A review of paediatric injectable drug delivery to inform the study of product acceptability - an introduction.

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Version 3 2023-06-09, 11:52
Version 2 2023-05-23, 11:30
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journal contribution
posted on 2023-06-09, 11:52 authored by Fabrice Ruiz, Anthony Nunn, Andrea Gill, David Clapham, Nikoletta Fotaki, Smita Salunke, Anne Cram, Fiona O'BrienFiona O'Brien

Aim

The EMA defines acceptability as “the overall ability and willingness of the patient to use, and their caregiver to administer, the medicine as intended” [1]. This paper seeks to outline issues of acceptability in relation to injectable therapy, namely intravenous (IV), intramuscular (IM) and subcutaneous (SC) administration routes, and to lay a foundation to identify a minimum set of data that would satisfy Regulatory Authorities when discussing the acceptability of an injectable product. In addition, it will alert drug product developers to other factors that might contribute to good practice, alternative administration strategies and overall adherence to achieve successful treatment.

Whilst the term ‘parenteral’ means “outside the intestine” [2], [3] and so potentially covers a range of administration routes including intranasal and percutaneous administration, this review focuses on IV, IM and SC administration by injection. The use of indwelling canulae or catheters to reduce venepuncture and facilitate prolonged treatment is common and may impact acceptability [4]. This may be influenced by information provided by the manufacturer but is not always in their direct control.

Other injectable products suitable for routes such as intradermal, intra-articular, intraosseous and intrathecal, share the requirement to be acceptable but are not specifically covered in this paper [2], [5].

History

Comments

The original article is available at https://www.sciencedirect.com/

Published Citation

Ruiz F. et al. A review of paediatric injectable drug delivery to inform the study of product acceptability - an introduction. Eur J Pharm Biopharm. 2023:188:265-270

Publication Date

24 April 2023

PubMed ID

37100092

Department/Unit

  • School of Pharmacy and Biomolecular Sciences

Research Area

  • Biomaterials and Regenerative Medicine

Publisher

Elsevier BV

Version

  • Published Version (Version of Record)