在珀色ENFit口服注射器中重新包装的洛拉泽巴姆口服溶液的稳定性研究
Collin Owczarzak1, Sara Woytowicz2, Fang Zhao2
1Strong Memorial Hospital Pharmacy (CO), University of Rochester Medical Center, Rochester, NY.
概括
在ENFit注射器中重新包装的洛拉泽帕姆口服缩剂在室温下保持稳定90天. 这一发现扩大了之前报告的稳定性,可能减少医院药房的浪费.
科学领域:
- 制药科学 制药科学
- 医院药房实践 医院药房实践
- 药物的稳定性 药物的稳定性
背景情况:
- 洛拉泽,一种用于治疗焦虑和的常见的二,由医院药房分发.
- 目前的做法涉及护士从散装瓶中提取患者特定的剂量.
- 洛拉泽口服缩剂含有聚乙烯糖醇和乙烯糖醇.
研究的目的:
- 评估lorazepam在重新包装成珀色ENFit口服注射器时的稳定性.
- 评估在环境温度下在典型的医院药房条件下进行储存.
- 确定减少医院环境中药物浪费的战略.
主要方法:
- 开发并验证了一种稳定性指标高性能液态染色学 (HPLC) 试验.
- 洛拉泽被置于压力条件 (酸性,基本性,氧化) 中,以确定降解概况.
- 重新包装的注射器在环境温度 (72 ± 4°F) 中储存了182天,并定期分析样本.
主要成果:
- 在ENFit口服注射器中重新包装的洛拉泽在182天后没有明显的变化.
- 在整个研究期间,度保持在可接受范围内 (100 ± 10%).
- 稳定性数据证实,洛拉泽在重新包装的注射器中在室温下保持稳定性长达90天.
结论:
- 在珀色ENFit口服注射器中重新包装的洛拉泽在环境温度下稳定90天.
- 与以前的报告相比,这项研究将已知的稳定期延长30天.
- 这些发现支持重新包装洛拉泽口服缩剂,以尽量减少医院药房的浪费.
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