用弹性体装置输注皮佩拉西林/塔佐巴克坦:一个24小时稳定性研究和药物溶液流速分析的联合研究
Laura Négrier1, Anthony Martin Mena1, Christian Dupont2
1Univ. Lille, CHU Lille, ULR 7365-GRITA-Groupe de Recherche sur les formes Injectables et les Technologies Associées, F-59000 Lille, France.
Pharmaceuticals (Basel, Switzerland)
|August 29, 2024
概括
用于治疗细菌性呼吸道感染的piperacillin/tazobactam (P/T) 溶液在24小时输液期间保持稳定. 然而,实际的药物流量比预期的要慢,可能是由于溶液粘度.
科学领域:
- 制药科学 制药科学
- 传染性疾病 传染性疾病
- 药物输送系统 药物输送系统
背景情况:
- 皮佩拉西林/塔扎巴克坦 (P/T) 对于治疗细菌性呼吸道感染至关重要,特别是在囊性纤维化患者中.
- 通过弹性体器件进行静脉输液是P/T溶液的常见施用方法.
- 评估药物稳定性和输液流量对于确保治疗疗效和患者安全至关重要.
研究的目的:
- 为了评估24小时稳定性和体外输液流量,从弹性体器件的piperacillin/tazobactam (P/T) 溶液.
- 为了比较通用与专有P/T配方的稳定性和流量特性.
- 通过使用弹性体输液识别P/T药物输送中的潜在挑战.
主要方法:
- 在体外模拟输注3个P/T溶液 (两个通用,一个专有) 在32°C使用弹性体装置.
- 稳定性评估包括HPLC-UV测定,pH,度,视觉检查和强制降解研究后的粒子计数.
- 使用精度尺度测量流量,在24小时内收集溶解溶液.
主要成果:
- 这三种P/T溶液在24小时输液期间都符合稳定性标准 (降解率<10%).
- 实际输注流量始终低于所有测试的P/T溶液的标称 (预期) 流量.
- 在通用和专有P / T配方之间没有观察到稳定性的显著差异.
结论:
- 皮佩拉西林/塔扎巴克坦溶液是稳定的24小时输液通过弹性体设备.
- 流量减少,可能是由于溶液粘度高,需要考虑在临床环境中准确的剂量.
- 建议对粘度相关的流速差异进行进一步调查,以优化P/T弹性体输液治疗.
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