通过干涂提高药物可加工性:实验室和试验规模的比较
Siddharth Tripathi1, M Sebastian Escotet-Espinoza1, James Tarabokija1
1New Jersey Center for Engineered Particulates (NJCEP), New Jersey Institute of Technology, Newark, NJ, USA; Merck & Co., Inc., Rahway, NJ, USA.
International journal of pharmaceutics
|May 16, 2025
概括
用纳米二氧化干涂层细制药粉末可以改善粉末流量和药片质量. 基于表面积覆盖面积的二氧化含量比标准的1 wt%更多地提高了性能,显示了连续制造的潜力.
科学领域:
- 制药技术 制药技术 制药技术
- 材料科学 材料科学 材料科学
- 化学工程是化学工程的重要组成部分.
背景情况:
- 用纳米来干涂细制药粉末增强了散装性能和混合加工能力.
- 这种技术显示了提高平板电脑制造效率的潜力.
研究的目的:
- 研究干燥涂层的工业应用.
- 根据表面覆盖面积 (SAC) 对比1重%.
- 评估使用试点规模的形磨机 (comil-U10) 与实验室规模的批量高强度振动混合机 (HIVM) 的连续干涂层可行性.
- 通过可供食性和可片性研究,检查下游加工改进.
主要方法:
- 测试了六种药物粉末 (d50 ~ 3-35微米),含有不同数量的二氧化.
- 使用流量能量 (FFC),豪斯纳比率,可压缩性和透性来描述粉末的性能.
- 评估了使用comil-U10的连续干涂层和使用HIVM的批量干涂层.
- 评估干涂材料的可食性和可片性.
主要成果:
- 基于SAC的二氧化选择在批量性能增强方面表现优于1 wt%.
- 流量能量 (FFC) 证明是最可靠的流动性指标.
- 康米尔处理改善了三种材料的流动性,尽管更细的粉末在HIVM中表现更好.
- 干涂材料表现出优越的料速度稳定性和减少的流量变化.
- 干涂配方的药片显示质量比混合的药片更好.
结论:
- 基于可扩展面的干涂层为连续平板制造提供了好处.
- 这种方法可以消除对颗粒的需求.
- 通过SAC优化含量对于有效的干涂层至关重要.
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