在SyrSpend® SF PH4中的心血管药物悬浮剂的抗菌稳定性,pH值和物理外观:补充评估
Carolina Schettino Kegele1, Eli Dijkers1, Hudson Polonini1
1Fagron BV, Rotterdam, The Netherlands.
International journal of pharmaceutical compounding
|September 17, 2025
概括
这项研究证实SyrSpend® SF PH4是一种安全有效的无防腐剂载体,用于合成口服液体药物. 心血管药物配方保持了抗微生物的有效性和稳定性,支持美国药典 (USP) 的超时使用日期 (BUD).
科学领域:
- 制药科学 制药科学
- 复合药房 复合药房 复合药房
- 药物的配方 药物的配方
背景情况:
- 随时的口服液体配方对于个性化药物治疗至关重要,特别是对于弱势群体.
- 无防腐剂的液体车辆需要对抗微生物安全性和物理化学稳定性的严格评估.
- 建立可靠的超使用日期 (BUD) 对于患者安全和监管合规至关重要.
研究的目的:
- 为了评估用SyrSpend® SF PH4制备的心血管药物配方的抗微生物有效性,pH稳定性和物理外观.
- 为这些临时配方提供支持建立符合美国药典 (USP) 的BUD的数据.
- 确认SyrSpend® SF PH4作为无防腐剂口服液体的载体的适用性.
主要方法:
- 使用SyrSpend® SF PH4制备了9种口服心血管药物悬浮剂.
- 配方在室温 (25°C) 和冷藏 (5°C) 保存90天.
- 定期监测pH和外表;通过USP<51>协议评估抗菌药物的有效性.
主要成果:
- 所有九种心血管药物配方都符合USP抗菌有效性标准.
- 在整个90天的研究中,观察到稳定的pH值和身体外观没有显著变化.
- 结果补充了之前的化学稳定性数据 (HPLC),表明性能强.
结论:
- SyrSpend® SF PH4是无防腐剂即时口服液体配方的可靠载体.
- 该车辆支持在符合USP的BUD.内安全使用复合性心血管药物.
- 这项研究验证了SyrSpend® SF PH4用于个性化药物治疗的应用.
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