为儿科制剂选择合适的辅料--儿科辅料风险评估(PERA)框架--第一部分。

IF 4.4 2区 医学 Q1 PHARMACOLOGY & PHARMACY European Journal of Pharmaceutics and Biopharmaceutics Pub Date : 2024-08-17 DOI:10.1016/j.ejpb.2024.114458
Smita Salunke , Anjali Agrawal , Jennifer Walsh , Anthony Nunn , Kevin Hughes , Peter Kuehl , Grazia Caivano , David Clapham , Karen Thompson , Alfred Rumondor , Brian Enright , Philip Sherratt
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引用次数: 0

摘要

辅料通常是制剂中的主要成分,对剂型、生产工艺、产品性能、稳定性和安全性有着至关重要的影响。它们在剂型中发挥着不同的作用和功能。选择具有适当安全性和耐受性的辅料是儿科制剂开发的一大障碍。特定辅料的适用性取决于其使用环境,包括儿科年龄范围、急性与慢性使用,以及疾病、活性物质和辅料的临床风险-效益。鼓励科学家应用风险-效益原则来评估辅料对特定儿科人群的适用性。监管机构提供了在评估辅料风险时应考虑的参数指示性清单和信息来源层次。然而,却缺乏应采取的方法和如何进行风险评估的细节。有必要采用系统的方法来选择辅料并评估辅料暴露的风险。本文开发并提出的儿科辅料风险评估(PERA)框架通过可定制的工具和流程提供了一个结构化、系统化的决策框架,有助于提高儿科制剂中辅料选择和使用理由的透明度和沟通。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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Selecting appropriate excipients for paediatric dosage form − Paediatric excipients risk assessment (PERA) framework – Part 1

Excipients are often the major component of the formulation that critically affect the dosage form, manufacturing process, product performance, stability and safety. They exert different roles and functions in a dosage form. Selecting excipients with appropriate safety and tolerability is a major hurdle in paediatric formulation development. The suitability of a particular excipient will be dependent on the context of its use with regard to the paediatric age range, acute versus chronic use, and clinical risk–benefit of the disease, active and excipient. Scientists are encouraged to apply the principle of risk–benefit to assess the suitability of excipients to the specific paediatric population. Indicative list of parameters that should be taken into consideration and hierarchy of information sources when assessing the excipients risks is provided by regulatory agencies. However, the approach to be taken and details of how the risk evaluation should be undertaken are lacking. There is a need for a systematic approach to selection of excipients and assessment of the risk of excipient exposure. The Paediatric Excipients Risk Assessment (PERA) framework developed and proposed in this paper provides a structured, systematic decision-making framework via customizable tools and processes that can help to improve the transparency and communications on the selection and justification of use of excipients in a paediatric formulation.

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来源期刊
CiteScore
8.80
自引率
4.10%
发文量
211
审稿时长
36 days
期刊介绍: The European Journal of Pharmaceutics and Biopharmaceutics provides a medium for the publication of novel, innovative and hypothesis-driven research from the areas of Pharmaceutics and Biopharmaceutics. Topics covered include for example: Design and development of drug delivery systems for pharmaceuticals and biopharmaceuticals (small molecules, proteins, nucleic acids) Aspects of manufacturing process design Biomedical aspects of drug product design Strategies and formulations for controlled drug transport across biological barriers Physicochemical aspects of drug product development Novel excipients for drug product design Drug delivery and controlled release systems for systemic and local applications Nanomaterials for therapeutic and diagnostic purposes Advanced therapy medicinal products Medical devices supporting a distinct pharmacological effect.
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