伊立替康化疗聚烯烃输注袋在剂量带条件下的长期和模拟使用稳定性。

IF 1 4区 医学 Q4 ONCOLOGY
Claire Andre, Lydie Lethier, Yves Claude Guillaume
{"title":"伊立替康化疗聚烯烃输注袋在剂量带条件下的长期和模拟使用稳定性。","authors":"Claire Andre, Lydie Lethier, Yves Claude Guillaume","doi":"10.1177/10781552251338763","DOIUrl":null,"url":null,"abstract":"<p><p>PurposeThe dose-banding of irinotecan provides the opportunity to anticipate the preparation of this anticancer drug on condition of carrying out stability studies. The aim of this study was to develop and validate a HPLC method for measuring the concentration of irinotecan and to evaluate its long-term stability at standardized rounded doses in polyolefin (POF) infusion bags at 4°C and protected from daylight. Microbiological and Physical stability tests were periodically performed including visual inspection, turbidity, lightness and chromaticity measurements. In addition, in a simulated in-use study, irinotecan quantification was also performed on the solution emitted from the POF infusion bags on a short period (24 h), at room temperature (25°C) and in daylight.MethodsThe HPLC with photodiode array (PDA) detector method was developed and validated (linearity, precision, accuracy, limits of detection and quantification, robustness and degradation test). Diluted irinotecan infusion solutions were aseptically prepared by further dilution of irinotecan stock solution with 0.9% sodium chloride in POF bags at banded doses 200 mg, 300 mg and 370 mg, the three most frequently produced doses in the pharmacy department. The POF bags were stored under refrigeration (4°C) in the dark (long term stability conditions) or at room temperature (25°C) in daylight for a short period 24 h (simulated in-use conditions). Microbiological tests were carried out and the physical and chemical stabilities were evaluated respectively through visual inspection, turbidity, lightness, chromaticity measurements and through chromatographic assays, pH and osmolality monitoring.ResultsThe long - term stability of irinotecan at selected standardized rounded doses (200 mg-300 mg-370 mg) in NaCl 0.9% polyolefin bags was confirmed for at least 84 days at 4 °C and in the dark. Microbiological tests performed on the samples were negative. As well, during the simulated in-use study, no signs of chemical instability were observed.ConclusionsA simple, accurate and stability-indicating HPLC method was developed to determine irinotecan concentrations in dose-banding conditions. As well, this present work including HPLC peak width, lightness and chromaticity measurements of a cytotoxic drug during the time of storage may be a guidance in stability studies. This study supports a centralized production of irinotecan in accordance with the studied conditions.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552251338763"},"PeriodicalIF":1.0000,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Long term and simulated in-use stabilities of irinotecan chemotherapy polyolefin infusion bags in dose banding conditions.\",\"authors\":\"Claire Andre, Lydie Lethier, Yves Claude Guillaume\",\"doi\":\"10.1177/10781552251338763\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>PurposeThe dose-banding of irinotecan provides the opportunity to anticipate the preparation of this anticancer drug on condition of carrying out stability studies. The aim of this study was to develop and validate a HPLC method for measuring the concentration of irinotecan and to evaluate its long-term stability at standardized rounded doses in polyolefin (POF) infusion bags at 4°C and protected from daylight. Microbiological and Physical stability tests were periodically performed including visual inspection, turbidity, lightness and chromaticity measurements. In addition, in a simulated in-use study, irinotecan quantification was also performed on the solution emitted from the POF infusion bags on a short period (24 h), at room temperature (25°C) and in daylight.MethodsThe HPLC with photodiode array (PDA) detector method was developed and validated (linearity, precision, accuracy, limits of detection and quantification, robustness and degradation test). Diluted irinotecan infusion solutions were aseptically prepared by further dilution of irinotecan stock solution with 0.9% sodium chloride in POF bags at banded doses 200 mg, 300 mg and 370 mg, the three most frequently produced doses in the pharmacy department. The POF bags were stored under refrigeration (4°C) in the dark (long term stability conditions) or at room temperature (25°C) in daylight for a short period 24 h (simulated in-use conditions). Microbiological tests were carried out and the physical and chemical stabilities were evaluated respectively through visual inspection, turbidity, lightness, chromaticity measurements and through chromatographic assays, pH and osmolality monitoring.ResultsThe long - term stability of irinotecan at selected standardized rounded doses (200 mg-300 mg-370 mg) in NaCl 0.9% polyolefin bags was confirmed for at least 84 days at 4 °C and in the dark. Microbiological tests performed on the samples were negative. As well, during the simulated in-use study, no signs of chemical instability were observed.ConclusionsA simple, accurate and stability-indicating HPLC method was developed to determine irinotecan concentrations in dose-banding conditions. As well, this present work including HPLC peak width, lightness and chromaticity measurements of a cytotoxic drug during the time of storage may be a guidance in stability studies. This study supports a centralized production of irinotecan in accordance with the studied conditions.</p>\",\"PeriodicalId\":16637,\"journal\":{\"name\":\"Journal of Oncology Pharmacy Practice\",\"volume\":\" \",\"pages\":\"10781552251338763\"},\"PeriodicalIF\":1.0000,\"publicationDate\":\"2025-05-13\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Oncology Pharmacy Practice\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/10781552251338763\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Oncology Pharmacy Practice","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/10781552251338763","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0

摘要

目的伊立替康的剂量带为在进行稳定性研究的前提下预测该抗癌药物的制备提供了机会。本研究的目的是建立和验证一种高效液相色谱方法来测量伊立替康的浓度,并评估其在4°C和日光保护下,在聚烯烃(POF)输注袋中以标准圆形剂量的长期稳定性。定期进行微生物和物理稳定性测试,包括目视检查、浊度、亮度和色度测量。此外,在模拟使用中研究中,在室温(25°C)和日光下,对短时间(24 h)从POF输液袋排出的溶液进行伊立替康定量。方法建立光电二极管阵列(PDA)高效液相色谱法,并对其进行了线性度、精密度、准确度、检出限和定量限、鲁棒性和降解试验等验证。将伊立替康原液用0.9%氯化钠进一步稀释,在POF袋中按200、300和370 mg(药房最常用的三种剂量)的频带剂量制备稀释伊立替康输注液。POF袋在黑暗(长期稳定条件)下冷藏(4°C)或在室温(25°C)下在日光下短时间储存24小时(模拟使用条件)。通过目测、浊度、亮度、色度测量和色谱分析、pH值和渗透压监测,分别进行了微生物学测试和物理和化学稳定性评估。结果伊立替康在标准圆形剂量(200 mg-300 mg-370 mg)下,在NaCl 0.9%聚烯烃袋中,在4°C和黑暗条件下,至少84天的长期稳定性得到证实。对这些样品进行的微生物检测呈阴性。同样,在模拟的使用研究中,没有观察到化学不稳定的迹象。结论建立了一种简便、准确、稳定的高效液相色谱法测定伊立替康浓度。同时,对细胞毒性药物在贮存期间的峰宽、亮度和色度的测定也可为稳定性研究提供指导。本研究支持依立替康在研究条件下的集中生产。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Long term and simulated in-use stabilities of irinotecan chemotherapy polyolefin infusion bags in dose banding conditions.

PurposeThe dose-banding of irinotecan provides the opportunity to anticipate the preparation of this anticancer drug on condition of carrying out stability studies. The aim of this study was to develop and validate a HPLC method for measuring the concentration of irinotecan and to evaluate its long-term stability at standardized rounded doses in polyolefin (POF) infusion bags at 4°C and protected from daylight. Microbiological and Physical stability tests were periodically performed including visual inspection, turbidity, lightness and chromaticity measurements. In addition, in a simulated in-use study, irinotecan quantification was also performed on the solution emitted from the POF infusion bags on a short period (24 h), at room temperature (25°C) and in daylight.MethodsThe HPLC with photodiode array (PDA) detector method was developed and validated (linearity, precision, accuracy, limits of detection and quantification, robustness and degradation test). Diluted irinotecan infusion solutions were aseptically prepared by further dilution of irinotecan stock solution with 0.9% sodium chloride in POF bags at banded doses 200 mg, 300 mg and 370 mg, the three most frequently produced doses in the pharmacy department. The POF bags were stored under refrigeration (4°C) in the dark (long term stability conditions) or at room temperature (25°C) in daylight for a short period 24 h (simulated in-use conditions). Microbiological tests were carried out and the physical and chemical stabilities were evaluated respectively through visual inspection, turbidity, lightness, chromaticity measurements and through chromatographic assays, pH and osmolality monitoring.ResultsThe long - term stability of irinotecan at selected standardized rounded doses (200 mg-300 mg-370 mg) in NaCl 0.9% polyolefin bags was confirmed for at least 84 days at 4 °C and in the dark. Microbiological tests performed on the samples were negative. As well, during the simulated in-use study, no signs of chemical instability were observed.ConclusionsA simple, accurate and stability-indicating HPLC method was developed to determine irinotecan concentrations in dose-banding conditions. As well, this present work including HPLC peak width, lightness and chromaticity measurements of a cytotoxic drug during the time of storage may be a guidance in stability studies. This study supports a centralized production of irinotecan in accordance with the studied conditions.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
CiteScore
2.70
自引率
7.70%
发文量
276
期刊介绍: Journal of Oncology Pharmacy Practice is a peer-reviewed scholarly journal dedicated to educating health professionals about providing pharmaceutical care to patients with cancer. It is the official publication of the International Society for Oncology Pharmacy Practitioners (ISOPP). Publishing pertinent case reports and consensus guidelines...
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信