Paediatric excipient risk assessment (PERA) tool and application for selecting appropriate excipients for paediatric dosage forms - Part 2.

Autor: Agrawal A; Novo Nordisk Inc., 300 North Beacon Street, Suite 501, Watertown, MA 02472, USA. Electronic address: vagr@novonordisk.com., Salunke S; European Paediatric Formulation Initiative (EUPFI), University College London School of Pharmacy, London WC1N 1AX, UK. Electronic address: s.salunke@ucl.ac.uk., Rumondor A; Bristol Myers Squibb, One Squibb Drive, New Brunswick, NJ 08901, USA. Electronic address: Alfred.Rumondor@bms.com., Thompson K; Merck & Co., Inc., 126 E Lincoln Ave, Rahway, NJ 07065, USA. Electronic address: karen_thompson@merck.com., Caivano G; Chiesi Farmaceutici S.p.A. Largo Francesco Belloli 11/A-43122 Parma, Italy. Electronic address: g.caivano@chiesi.com., Walsh J; Jenny Walsh Consulting Ltd., Nottingham, UK. Electronic address: jenny@jennywalshconsulting.com., Enright B; Abbvie Inc. 1 N Waukegan Road, North Chicago, IL, 60064, USA. Electronic address: Brian.Enright@abbvie.com., Sherratt P; Bristol Myers Squibb, 556 Morris Avenue, Summit, NJ 07901, USA. Electronic address: Philip.Sherratt@bms.com., Hughes K; IPEC Europe (International Pharmaceutical Excipients Council) and Colorcon Ltd, Dartford, UK. Electronic address: KHughes@colorcon.com., Clapham D; Independent Pharmaceutical Consultant, Bishops Stortford, UK. Electronic address: david.clapham@ntlworld.com., Kuehl P; F. Hoffmann La Roche AG, Grenzacher Str. 124, CH-4070 Basel, Switzerland. Electronic address: peter.kuehl@roche.com.
Jazyk: angličtina
Zdroj: European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V [Eur J Pharm Biopharm] 2024 Oct; Vol. 203, pp. 114447. Date of Electronic Publication: 2024 Aug 08.
DOI: 10.1016/j.ejpb.2024.114447
Abstrakt: It is necessary to use a scientifically sound process for excipient risk evaluation, selection, and management in order to develop paediatric medicinal products that are both safe and effective. The "Paediatric Excipient Risk Assessment (PERA)" framework, which proposes a comprehensive approach by considering all relevant factors related to patient, dosage form, and excipient attributes, was developed and published as part 1 of this paper series, to enable the rational selection of excipients for paediatric medicinal products. This article is Part 2 of the series and presents the PERA tool that allows easy adoption of the PERA framework. Using a straightforward heat map scoring approach (Red, Yellow, and Green category) for risk evaluation, the PERA tool can be used to compare and choose excipients. The PERA tool will help users identify potential gaps in excipients information that will help with risk-based mitigation planning. Several case studies covering frequently used and novel excipients for oral, as well as the choice of excipient for parenteral products for neonatal administration, serve to illustrate the PERA tool's usefulness.
Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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