工程稳定阿姆洛迪平悬浮剂用于灵活的化合物在哈利德国王大学医院的工程稳定阿姆洛迪平悬浮剂
Ehab Elzayat1, Hadyah F Alotaibi2, Mohamed H Al-Agamy2
1Department of Pharmaceutics, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia. eelzayat1.c@ksu.edu.sa.
概括
即使在使用条件下,即时的安洛迪平悬浮液也保持了3个月的稳定性,支持美国药典.
科学领域:
- 制药科学 制药科学
- 药物的配方 药物的配方
- 稳定性测试 稳定性测试
背景情况:
- 临时液体配方对于患有吞困难的患者至关重要.
- 美国药典 (USP) 建议使用阿姆洛迪平悬浮剂的逾期期为3个月.
- 活性药物成分 (API) 来源的变化和原材料的可用性带来了配方挑战.
研究的目的:
- 评估即时使用的阿姆洛迪平悬浮剂的物理化学和微生物稳定性.
- 调查不同API来源和配方参数对稳定性的影响.
- 为了验证USP对这些悬浮剂的推的3个月的过期使用日期.
主要方法:
- 使用各种药片/囊,制造商,强度和储存条件,准备了八种阿姆洛迪平 suspension配方.
- 评估的物理稳定性 (体感器官特性,pH),化学稳定性 (HPLC-UV) 和微生物稳定性 (微生物计数).
- 在模拟的使用和封闭条件下存储配方3个月.
主要成果:
- 所有配方在5°C下保持稳定3个月.
- 药物含量始终保持不变 (平均值为103.94%±1.79%SD).
- 没有检测到微生物生长,即使是在模拟的使用条件下.
结论:
- 证实了美国药物监督局对非临时性阿姆洛迪平悬浮剂的3个月的超出使用日期建议.
- 支持3个月的使用稳定性,提高患者的便利性和减少浪费.
- 展示了配方的灵活性,适应了API来源的变化和市场短缺.
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