在室温下耐热药物的稳定性. 一个审查审查
Paloma Suárez-Casillas1, Santiago José Lora-Escobar1, Elena Montecatine-Alonso1
1UGC Farmacia, Hospital Universitario Virgen del Rocío, Sevilla, Spain.
概括
大多数可热化药物在室温下保持稳定可接受的时间,其中许多持续超过一个月. 这种全面的稳定性数据有助于医院药房优化药物存储和管理.
科学领域:
- 制药科学 制药科学
- 药物的稳定性 药物的稳定性
- 热可移药物 热可移药物 热可移药物
背景情况:
- 热敏药物日益普及,需要明确的储存指南.
- 准确的稳定性数据对于医疗保健机构有效的药物管理至关重要.
研究的目的:
- 编制并提供可访问的关于可热化药物的室温稳定性的信息.
- 为了整合产品特性总结 (SmPC),文献和制造商的数据.
主要方法:
- 选择了203种需要冷藏 (2-8°C) 的可热化药物.
- 不包括临床试验,冷和复合药物.
- 系统地审查SmPC,发表文献,并与制造商联系以获得稳定性数据.
主要成果:
- 在203种热可溶性药物中,超过80%的药物在室温 (22-25°C) 下至少24小时保持稳定.
- 很大一部分 (25.6%) 在一个多月内保持稳定.
- 稳定性数据来源包括SmPC (46.7%),文献 (27.5%) 和制造商 (26.2%).
结论:
- 大多数可热性药物在室温下表现出足够的稳定性,在临床上具有相关的持续时间.
- 这项研究提供了迄今为止最大的数据集,为医院药房提供了宝贵的资源.
- 建议包括制造商在SmPC中发布更广泛的稳定性数据.
相关概念视频
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