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多拉韦林（Pifeltro）的物理化学稳定性：主要降解产物的表征及重新包装于单剂量单位容器中的片剂稳定性评估。

Physicochemical Stability of Doravirine (Pifeltro): Characterization of Main Degradation Products and Assessment of Stability of Tablets Repackaged in Single-Dose Unit Containers.

作者信息

Houssen Moïse, Secretan Philippe-Henri, Nobilet Loup, Jossot Kilian, Guichard Laura, Mwamba Cédric, Ngy David, Hassani Lamia, Solgadi Audrey, Antignac Marie, Do Bernard, Junot Helga, Sadou Yayé Hassane

机构信息

Department of Pharmacy, Hôpitaux Universitaires Pitié-Salpêtrière, AP-HP, 75013 Paris, France.

Matériaux et Santé, Université Paris-Saclay, 91400 Orsay, France.

出版信息

Pharmaceutics. 2024 Jul 24;16(8):977. doi: 10.3390/pharmaceutics16080977.

DOI:10.3390/pharmaceutics16080977
PMID:39204322
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11359146/
Abstract

Doravarine (DOR) is an antiviral drug with a marketed authorization for the management of occupational blood and body fluid exposure. The currently existing packaging, consisting of multiple unit bottles comprising 30 tablets, is not fully appropriate for daily nominative dispensing at the hospital. This study aims at assessing the impact of the change in packaging on the key attributes of the drug: assay, impurity profile, and dissolution. As the first step, which is not fully depicted in the literature, the main potential impurities that could appear during storage (i.e., degradation products (DPs) of DOR) were characterized using a forced degradation protocol followed by an LC-MS/MS analysis. These results paved the way for in silico toxicological assessment and targeted degradation product profiling. Based on this study, the assessment of the implication of repackaging on the formation of DOR's degradation products should be a primary focus.

摘要

多拉韦林（DOR）是一种已获上市许可用于职业性血液和体液暴露管理的抗病毒药物。目前的包装由多个装有30片药片的单位瓶组成，不完全适合医院日常的实名制配药。本研究旨在评估包装变更对该药物关键属性的影响：含量测定、杂质概况和溶出度。作为第一步（文献中未充分描述），使用强制降解方案并随后进行液相色谱-串联质谱（LC-MS/MS）分析，对储存期间可能出现的主要潜在杂质（即多拉韦林的降解产物（DPs））进行了表征。这些结果为计算机毒理学评估和靶向降解产物分析铺平了道路。基于本研究，评估重新包装对多拉韦林降解产物形成的影响应成为主要关注点。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff3b/11359146/fdf7edb9e44c/pharmaceutics-16-00977-g009.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff3b/11359146/9da149b303fb/pharmaceutics-16-00977-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff3b/11359146/6b99f687ae54/pharmaceutics-16-00977-g002a.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff3b/11359146/d995202d0ed9/pharmaceutics-16-00977-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff3b/11359146/4c8cdad1b261/pharmaceutics-16-00977-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff3b/11359146/f3f06a71fb4e/pharmaceutics-16-00977-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff3b/11359146/3a5e02e3af8e/pharmaceutics-16-00977-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff3b/11359146/ccfbdfde7443/pharmaceutics-16-00977-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff3b/11359146/3850c4358e13/pharmaceutics-16-00977-g008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff3b/11359146/fdf7edb9e44c/pharmaceutics-16-00977-g009.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff3b/11359146/9da149b303fb/pharmaceutics-16-00977-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff3b/11359146/6b99f687ae54/pharmaceutics-16-00977-g002a.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff3b/11359146/d995202d0ed9/pharmaceutics-16-00977-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff3b/11359146/4c8cdad1b261/pharmaceutics-16-00977-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff3b/11359146/f3f06a71fb4e/pharmaceutics-16-00977-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff3b/11359146/3a5e02e3af8e/pharmaceutics-16-00977-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff3b/11359146/ccfbdfde7443/pharmaceutics-16-00977-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff3b/11359146/3850c4358e13/pharmaceutics-16-00977-g008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff3b/11359146/fdf7edb9e44c/pharmaceutics-16-00977-g009.jpg

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