container-content interactions

  • 文章类型: Journal Article
    这篇透视文章解决了静脉注射药物管理中容器内容物相互作用的关键问题,专注于核医学中使用的放射性药物。药物施用错误对患者安全构成重大挑战。“五权”框架——确保合适的病人,药物,时间,剂量,和途径-作为安全药物管理的基石。在放射性药物的背景下,值得注意的是它们在核医学中的用途,遵守这些原则是至关重要的,因为它们在诊断和治疗程序中的独特特性和作用。本文探讨了容器材料的影响,特别是在注射器中,关于放射性药物的稳定性和给药准确性。它深入研究了吸附现象的复杂性,强调证明其发生和潜在后果的研究,包括给药剂量的变化和受损的诊断或治疗结果。影响吸附的值得注意的因素包括放射性药物的类型,容器成分,分子性质,和稀释。结果揭示了注射器中的残留活性并确定了特定成分,如润滑剂,硅垫片,和柱塞,提出了对吸附的贡献。讨论了金属污染物从容器到内容物的迁移,强调对放射化学产率和稳定性的潜在影响。需要进行全面的研究来表征药物-容器相互作用,并提出有关患者从规定活动中获得的真正益处的关键问题。它挑战当前的做法,建议需要定制的活动水平,容器验证协议,和医院制剂的严格测试。最终,这篇透视论文呼吁对这些相互作用有更深入的理解,敦促监管考虑和标准化,以确保最佳的药物管理和患者预后。
    This perspective article addresses the critical issue of container-content interactions in the administration of intravenous medications, with a focus on radiopharmaceuticals used in nuclear medicine. Medication administration errors pose a significant challenge to patient safety. The \"five rights\" framework-ensuring the right patient, drug, time, dose, and route-serves as a cornerstone for safe drug administration. In the context of radiopharmaceuticals, notable for their use in nuclear medicine, adherence to these principles is paramount due to their unique properties and role in diagnostic and therapeutic procedures. The article explores the impact of container materials, particularly in syringes, on radiopharmaceutical stability and administration accuracy. It delves into the complexities of sorption phenomena, highlighting studies demonstrating its occurrence and potential consequences, including variations in administered doses and compromised diagnostic or therapeutic outcomes. Noteworthy factors influencing sorption include the type of radiopharmaceutical, container composition, molecular properties, and dilution. Findings revealing residual activity in syringes and identifying specific components, such as lubricants, silicon gaskets, and plungers, contributing to adsorption are presented. Migration of metal contaminants from container to content is discussed, emphasizing the potential impact on radiochemical yield and stability. There is a need for comprehensive studies to characterize drug-container interactions and poses crucial questions about the true benefit patients derive from prescribed activities. It challenges current practices, suggesting a need for tailored activity levels, container validation protocols, and rigorous testing of hospital preparations. Ultimately, this perspective paper calls for a deeper understanding of these interactions, urging regulatory consideration and standardization to ensure optimal drug administration and patient outcomes.
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  • 文章类型: Journal Article
    背景:医用注射器在医院中广泛用于存储和管理药物,药物和这些注射器之间的接触时间可以从几分钟到几周不等,就像药物制剂一样。这项比较研究的目的是评估三种药物(扑热息痛,地西泮和门冬胰岛素)和聚丙烯注射器(PP)或由环烯烃共聚物(COC)制成的注射器。
    方法:由COC制成的50mL3部分注射器,其中COC内表面带有交联有机硅(COC-CLS)和溴丁基柱塞密封,或使用带有聚异戊二烯柱塞密封件的硅油(PP-SOL)润滑的PP。
    结果:与PP-SOL注射器相比,COC-CLS注射器诱导地西泮和胰岛素的吸收较少,柱塞密封材料似乎是这些相互作用的主要原因。观察到与PP-SOL注射器接触的药物的碱化。它可能是由可浸出的化合物引起的,应该进一步研究。
    结论:这项工作再次表明,必须考虑内容物-容器的相互作用,以帮助提高肠胃外药物的安全使用。
    BACKGROUND: Medical syringes are widely used in hospitals to store and administer drugs, and the contact time between the drugs and these syringes can vary from a few minutes to several weeks like for pharmaceutical preparations. The aim of this comparative study was to evaluate the potential sorption phenomena occurring between three drugs (paracetamol, diazepam and insulin aspart) and polypropylene syringes (PP) or syringes made of Cyclic Olefin Copolymer (COC).
    METHODS: 50 mL 3-part syringes made of either COC with crosslinked silicone on the barrel inner surface (COC-CLS) and a bromobutyl plunger seal, or PP lubricated with silicone oil (PP-SOL) with a polyisoprene plunger seal were used.
    RESULTS: COC-CLS syringes induced less sorption of diazepam and insulin than PP-SOL syringes and the plunger seal material seemed to be the main cause of these interactions. An alkalinization of the medications in contact with the PP-SOL syringes was observed. It could be caused by leachable compounds and should be investigated further.
    CONCLUSIONS: This work shows once again that it is essential to consider content-container interactions to help improve the safe use of parenteral drugs.
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  • 文章类型: Journal Article
    Migration of molecules from packaging into products is a well-known phenomenon of which the studies in the food and medical industries are regulated in Europe by several legislations. However, for cosmetic packagings, there is no protocol nor specific migration limits available. The objective of this work was to use glycerin and liquid paraffin as cosmetic product simulants to perform a safety assessment on phthalates in 11 plastic packagings used in the cosmetic industry. To study these compounds in the matrices, 2 extraction techniques were compared: liquid-liquid extraction and solid-phase microextraction (SPME). The optimization of the 2 processes of extraction showed that SPME was more adapted to the study. Finally, samples of glycerin and liquid paraffin were analyzed by a SPME-GC-MS method to quantitate 10 regulated phthalates. In glycerin, only DEP was quantitated above the LOQ in 3 packagings, but the concentrations measured were under the set concentration threshold of 0.5 ppm. In liquid paraffin, DEP was quantitated above this concentration threshold. A safety evaluation was so performed by calculating the systemic exposure damage, and the results were finally considered to be safe for consumers.
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  • 文章类型: Journal Article
    Container-content interactions are common in the food and pharmaceutical industries. However, these studies are more complicated in the cosmetic industry, and it is necessary to ensure consumer safety. The objective of this work was to develop a strategy for the toxicological evaluation of leachables for cosmetic packagings. Eleven common plastic packagings were selected to evaluate interactions with 5 simulants (acidic, alkaline and neutral water, 30% and 96% ethanol) chosen to mimic cosmetics behavior. A GC-MS method was developed to screen for 12 non-intentionally added substances of particular concern: 10 phthalates, bisphenol A and distearyl thiodipropionate (European Pharmacopoeia plastic additive 17). Results were analyzed using a toxicological procedure established for this study. Some phthalates and bisphenol A were detected in several samples, but only one contaminant, diisobutyl phthalate (DiBP), was found to be above the set concentration threshold. Using toxicological data, this concentration was found to be safe for users. 96% ethanol appeared to be the strongest simulant in term of extraction, with a maximum concentration of 491 μg/L for DiBP in a 100% styrene-acrylonitrile copolymer packaging. In water simulants, less contaminants were extracted, with concentrations under 20 μg/L.
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