通过表面修饰来优化无形固体分散辅助剂粉体的批量流量
Danni Suhaidi1, Yao-Da Dong2, Paul Wynne3
1School of Engineering, Deakin University, Waurn Ponds, VIC 3216, Australia.
Pharmaceutics
|May 27, 2023
概括
对于许多辅助剂来说,L-氨酸共处理提高了无形固体分散 (ASD) 粉末的流动性. 这项研究研究了L-leucine.
科学领域:
- 制药科学 制药科学
- 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:
- 无形固体分散 (ASDs) 在固体剂型中增强药物的口服生物可用性和宏分子稳定性.
- 喷雾干燥的ASD表现出表面凝聚力和高度,对粉末流动和加工产生负面影响.
- 表面修改对于改善ASDs的散装特性至关重要.
研究的目的:
- 研究L-leucine (L-leu) 共处理在改变ASD形成材料的颗粒表面的有效性.
- 评估L-leu对各种原型ASD助剂的散装特性和流动性的影响.
- 了解L-leu在与不同聚合物共同配制时的机械行为.
主要方法:
- 与各种原型ASD辅助剂共同处理L-氨酸,包括马尔托德克斯,聚烯 (PVP K10和K90),三糖,阿拉伯和基甲基纤维素 (HPMC E5LV和K100M).
- 在受控条件下喷雾干燥,以尽量减少颗粒大小对凝聚力的影响.
- 使用扫描电子显微镜 (SEM) 的形态评估.
- 散装粉末的特征化使用粉末风力计来评估流动性,流速灵敏度和紧缩性.
主要成果:
- 通过L-氨酸的共同处理,通常可以提高马尔托德素,PVP K10,三糖和阿拉伯配方的流动性.
- 扫描电子显微镜揭示了粒子表面的已知和新的形态变化.
- 聚烯利 K90 和基甲基纤维素配方提出了独特的挑战,为L-leucine的机械行为提供了洞察力.
结论:
- 氨酸是一种有效的辅助剂,可以改善某些无形固体分散物的粉末流动特性.
- 建议进行进一步的研究,以探索L-氨酸与配方辅助剂的物理化学特性之间的相互作用.
- 需要增强的批量表征工具,以充分理解L-氨酸表面修饰的多因素影响.
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