SIOPE 和 ESOP 关于儿科肿瘤口服液体药物制剂即席配制的建议

Marko Otsokolhich , Maxime Annereau , Tiene Bauters , Laszlo Horvath , Chahinez Nehal , Sherif Kamal , Gilles Vassal , Svetlana Buraja
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引用次数: 0

摘要

导言儿童恶性肿瘤口服药物缺乏适合儿童年龄的制剂是一个关键且持续存在的问题,亟待解决。根据 JARC 调查,27% 的口服药物从未采用过适合儿童的配方(Vassal 等人,2021 年 [2])。欧洲肿瘤药学全球学会 (ESOP) 和欧洲儿科肿瘤学会 (SIOPE) 的药剂师们合作编写了一份文件,总结了有关该主题的文献数据,并提供了一套关于配制即用口服液体药物的实用指南。将配制药物的必要信息制成表格。我们采用了国际注射剂稳定性数据库 Stabilis®(A-C 级)的分子稳定性等级分类模型。通过全球可访问的药物数据库,对用于儿童癌症的所有市售口服液药物进行了综述,并将其与相应的适应症汇编成表。结论应鼓励制药业开发适合儿童的抗癌药物制剂,以获得上市许可,从而提高药物的可及性。这项研究的结果有助于促进欧洲即刻制剂标准的制定,并说服儿科肿瘤学领域的研究人员继续前进。
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SIOPE and ESOP recommendations for extemporaneous compounding of oral liquid medicine formulations in paediatric oncology

Introduction

Scarcity of age appropriate formulations for orally administered medicines for paediatric malignancies is a critical and ongoing issue which necessitates urgent solutions. According to JARC Survey 27 % of oral medicines were never available in child-friendly formulations (Vassal et al., 2021 [2]). Pharmacists from the European Society of Oncology Pharmacy Global (ESOP) and the European Society for Pediatric Oncology (SIOPE) have collaborated to provide a document summarising literature data on this topic and a set of practical instructions on the preparation of extemporaneous oral liquid medicines.

Material and methods

Literature review was conducted for the preparation of oral medicines for paediatric cancer, through Pubmed 2.0. A table was drawn up with necessary information for medicine preparation. We adapted the classification model of the molecule stability ranking of the International database of stability for injectable drugs, Stabilis® (Class A–C).

Results

A total of 126 articles were selected and analysed. All commercially available marketed liquid oral medications used in paediatric cancer were overviewed using globally accessible drug databases and compiled in a table with appropriate indications. Based on the literature review, 28 formulations for 13 different active ingredients for chemotherapy and 35 formulations for 16 different active ingredients for supportive therapy were compiled.

Conclusions

Development of child-appropriate formulations of anticancer medicines by the pharmaceutical industry should be incentivised towards marketing authorisation to enhance accessibility. The results of this study could help facilitate creation of European standards for extemporaneous preparation and persuade researchers in the field of paediatric oncology on the way forward.

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