确保稳健的药物输送:对3ml RTU药筒机械和化学性能的综合研究。

Q3 Medicine
Robert Lindner, Daniele Zuccato, Volker Rupertus
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引用次数: 0

摘要

在更多以患者为中心的家庭治疗的推动下,制药行业正在转向皮下药物配方,特别是生物制剂。这有助于简化患者自我管理,提高依从性,并降低医疗成本。因此,对优化的药物控制系统的需求日益增加,因为这些系统将经常由非专业人员在家庭环境中使用。本研究评估了cartriQ®3ml即用型(RTU)药盒的分离力和滑动力(BLGF)以及无机和有机可浸出特性,以确保安全有效的给药。该墨盒由FIOLAX®透明型硼硅酸盐玻璃制成,经过热成型成管状墨盒,确保抗水解性不超过ISO 4802-1限制的80%,然后进行洗涤,硅化和蒸汽灭菌。使用超纯水、组氨酸缓冲液和磷酸盐缓冲液作为模型溶液,在40°C下加速老化24周后进行测试。关键性能指标,包括BLGF、硅化性能和无机浸出物水平,如硼、钠、硅和精选有机浸出物,均按照ISO 21881和ICH Q3D指南进行评估。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Ensuring Robust Drug Delivery: A Comprehensive Study on the Mechanical and Chemical Performance of 3 ml RTU Cartridges.

Driven by more patient-centric at-home treatments, the pharmaceutical industry is shifting toward subcutaneous drug formulations, particularly for biologics. This aids in simplifying patient self-administration, improving adherence, and reducing healthcare costs. Hence, there is an increasing need for optimized drug containment systems, as these will frequently be used by non-professionals in home settings. This study evaluates the break-loose and gliding forces (BLGF) as well as the inorganic and organic leachable profiles of cartriQ® 3 mL ready-to-use (RTU) cartridges to ensure safe and effective drug delivery. The cartridges, made from FIOLAX® clear Type I borosilicate glass, underwent hot forming into tubular cartridges, ensuring a hydrolytic resistance of not more than 80% of the ISO 4802-1 limit, followed by washing, siliconization, and steam sterilization. Testing was conducted after accelerated aging over up to 24 weeks at 40°C using ultrapure water, histidine buffer, and phosphate buffer as model solutions. Key performance metrics, including BLGF, siliconization performance, and levels of inorganic leachables, e.g., boron, sodium, silicon, and select organic leachables, were assessed following ISO 21881 and ICH Q3D guidelines.

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来源期刊
CiteScore
1.90
自引率
0.00%
发文量
34
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