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发表于 2013-8-30 15:06:58
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11. What should drug manufacturers do to prevent formation of glass lamellae (glass fragments) in injectable drugs filled in small-volume glass vials?
11.怎么避免注射药在小容量西林瓶形成玻璃片晶（玻璃碎屑）？
Under certain conditions, glass vials can shed thin, flexible fragments called “glass lamellae” (1, 2). These lamellae are shed from the interior surface of the glass container directly into the drug and are difficult to detect by visual inspection. Several drugs have recently been recalled due to this problem (3).
在某些条件下，西林玻璃瓶可以脱落薄的，韧性的碎屑，称为“玻璃片晶”（1,2）这些片晶由玻璃容器内表面直接进入药品，并且目视检查很难发现。若干药品近期因为这些问题而被召回（3）。
No adverse events to date have been reported nor can be directly attributed to this phenomenon. However, there is the potential for drugs administered intravenously that contain these fragments to cause embolic, thrombotic and other vascular events (e.g., phlebitis); and, when administered subcutaneously, to lead to development of foreign body granuloma, local injection site reactions, and increased immunogenicity (4).
但迄今为止没有不良事件报道，不良事件也不能直接归咎于此现象。然而，含有碎屑的药物通过静脉注射有可能会导致病人出现栓塞、血栓或其他血管问题（比如静脉炎）；或者当皮下给药时导致异物性肉芽肿，局部注射部位反应，以及增加免疫原性（4）。
The following conditions have been associated with a higher incidence of the formation of glass lamellae:
较易形成玻璃片晶的（原因）与下面的条件有关：
 Glass vials manufactured by a tubing process (and thus manufactured under higher heat). These vials are less resistant than molded glass vials and may shed lamellae more easily (5). The processing conditions used to manufacture glass vials can be designed to mitigate the potential for later delamination.
 玻璃西林瓶由成管法（高热下加工）制造。该西林瓶相比模制玻璃法的西林瓶不够牢固，可能会更易脱落片晶（5）。应设计加工条件来减小后续分层可能性。
 Drug solutions formulated at high pH (alkaline) and with certain buffers. Common buffers associated with lamellae formation include citrate and tartrate (6).
 高pH（碱性）和特定的缓冲液配制而成的药物溶液。常用的缓冲液，包括柠檬酸盐和酒石酸盐与片晶形成有关（6）。
 Length of time the drug product is exposed to the inner surface of the container. The time duration has a direct correlation to the potential for glass lamellae formation to occur during the product shelf life (1).药品暴露在容器内表面的持续时间。在产品保存期限内，该暴露时间与玻璃片晶的形成直接相关（1）。
 Drug products with room temperature storage requirements. Drugs stored at room temperature have a greater chance of glass lamellae formation than do products stored at colder temperatures (7).
 需要室温储藏的药瓶。药品在室温下储藏的相比在较冷温度下储藏的，有很大几率形成玻璃片晶。
 Terminal sterilization has a significant effect on glass stability (2).
 最终灭菌对玻璃稳定性有重大影响（2）。
The referenced literature, below, includes recommended actions to help prevent the formation of glass lamellae. For example, for products “at risk,” the vial surface alkalinity can be minimized by proper selection of glass composition (e.g., highly resistant, non-alkaline earth borosilicate glass), appropriate selection and qualification of vendors, and proper quality control of the incoming vials. Accordingly, FDA advises drug manufacturers of products to re-examine their supplier quality management program with the glass vial manufacturers to assure that this phenomenon is not occurring. Further, the Agency reminds finished drug product manufacturers that the current good manufacturing practice regulations require that drug containers not be reactive or additive so as to alter the safety or quality of the drug (8, 9,10).
下面的参考文献，其包括推荐的措施以帮助阻止玻璃片晶的形成。例如，“带风险”的产品，通过选择适当的玻璃成分（例如，高强度、非碱性土的硼硅酸盐玻璃）而减少西林瓶表面的碱性，适当的供应商选择和资质确认，对到货的西林瓶进行恰当的质量控制。相应地，FDA建议药品生产商复检供应商的玻璃瓶的生产质量管理程序，确保此现象不再出现。进一步地，代理机构提醒最终药品生产商：CGMP要求药用容器是无反应性的且不可添加异物的，以致改变安全性或药品质量（8,9,10）。
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发表于 2013-8-30 15:12:48
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