药品纳米和微悬浮的长期与短期压力物理稳定性的评估
1Department of Physics, Chemistry, and Pharmacy, University of Southern Denmark, Campusvej 55, 5230 Odense, Denmark.
International journal of pharmaceutics
|April 28, 2025
概括
锡纳瑞悬浮剂的物理稳定性至关重要. 短期压力测试预测长期稳定性,储存温度是关键因素. 较高的聚酸盐20度提高了稳定性,特别是在高温下.
科学领域:
- 制药科学 制药科学
- 物理化学 物理化学
- 材料科学 材料科学 材料科学
背景情况:
- 纳米和微悬浮的物理稳定性对于配方开发至关重要.
- 短期压力研究是长期悬浮稳定性的预测工具.
- 辛纳瑞悬浮剂需要精心配制,以确保其物理完整性.
研究的目的:
- 为了比较辛纳瑞悬浮剂的短期应力稳定性及其长期储存稳定性.
- 为了评估储存温度和机械应力的影响在肉氨酸悬浮液颗粒大小.
- 为了确定聚酸盐20的最佳度,以稳定肉氨酸悬浮剂.
主要方法:
- 使用双离心 (1毫升尺度) 和振动器珠磨机 (上升尺度) 制备辛纳瑞悬浮剂.
- 通过机械应力 (旋转,震动) 和热循环来评估短期应力稳定性.
- 在不同温度 (5°C,25°C,40°C) 下18个月的长期储存稳定性的评估.
主要成果:
- 在短期和长期研究中,储存温度显著影响了颗粒大小概况.
- 仅仅机械应力就导致了微小的粒子大小变化;热循环导致了不稳定.
- 高度的聚酸盐20改善了颗粒大小的特征,特别是在热应力下和长期储存在高温下.
- 在5°C储存的悬浮物保持相对稳定,而在25°C和40°C储存的悬浮物则随着时间的推移显示出粒子大小的增加,特别是在1%的聚酸盐20中.
结论:
- 储存温度是肉麻悬浮物体稳定性的主要决定因素.
- 聚二酸盐20度对于稳定性至关重要,长期储存需要更高的百分比,特别是在更高的温度下.
- 短期压力研究可以提供稳定性的早期迹象,但在相关的储存条件下进行长期评估对于配方优化至关重要.
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