固体含量对冷解粉末散装性质的影响
Zijian Wang1, Sichen Song2, Hongwei Zhang3
1Department of Pharmaceutics, College of Pharmacy, University of Minnesota, Minneapolis, MN 55455, USA.
International journal of pharmaceutics
|December 22, 2024
概括
在冷化过程中增加固体含量可以提高粉末密度,但对于口服药物产品开发来说还不够. 进一步的表征对于优化冷解材料至关重要.
科学领域:
- 制药科学 制药科学
- 材料科学 材料科学 材料科学
- 生物技术是生物技术.
背景情况:
- 通过口服输送的生物药物,通常通过冷化制备,正在引起人们的兴趣.
- 低固体含量溶液通常用于冷化,导致下游加工的粉末性能差.
- 较高的固体含量可能会提高粉末密度,但其对其他性能的影响尚不清楚.
研究的目的:
- 为了研究固体含量增加对冷化冷保护剂特性的影响.
- 评估是否更高的固体含量可以改善口服药物开发的粉末密度和流动性.
- 为了评估固体特性,紧缩和稳定性在变化的固体含量下发生的变化.
主要方法:
- 在5%和10%的固体含量下,三种常见的冷保护剂的冷化.
- 系统评估固态特性,散装密度和流动性.
- 溶解粉末的压缩特性和物理稳定性的分析.
主要成果:
- 在10%固体含量下制备的粉末显示出较高的散装密度,而5%.
- 尽管有所改进,10%的固体含量粉末不符合口服产品开发的要求.
- 改变固体含量显著影响了固体特性,压缩行为和稳定性.
结论:
- 在冷凍化中增加固體含量可提高粉末密度,但對於口服劑量形式來說不足.
- 固体含量的变化需要对冷化材料进行彻底的表征,以开发配方.
- 优化冷化条件对于开发强大的口服生物药品至关重要.
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