喷雾干燥的曼尼托尔-氨酸系统的处理空间用于肺部药物输送
Riley T Schweizer1,2, Mani Ordoubadi3, Cody A Prather1
1Research & Development, Lonza Group AG, Bend, OR 97703, USA.
Pharmaceutics
|March 28, 2024
概括
喷雾干燥氨酸和曼尼托尔用于吸入需要仔细控制. 配方中的初始氨酸度是实现所需粉末特性和晶体表面外以改善性能的关键.
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:
- 优化喷雾干燥颗粒的吸入需要控制空气动力学直径和粉末的分散性.
- 氨酸是一种两类氨基酸,在吸入配方中改善了散装粉末的特性.
- 曼尼托尔 (Mannitol) 作为一种典型的晶体活性制药成分和一种常见的填充剂.
研究的目的:
- 在联合喷雾干燥过程中研究氨酸和曼尼托尔二元晶体系统中的颗粒形成机制.
- 为了确定辅助剂比率,乙醇/水比率和喷雾干燥机出口温度对颗粒性质的影响.
- 了解组件的表面丰富如何影响粉末的特性和随时间的稳定性.
主要方法:
- 在不同的配方和工艺参数下联合喷雾干燥柳和曼尼托尔.
- 固态特征 (例如,X射线衍射,显微镜) 来分析晶体结构和表面组成.
- 颗粒大小分析和视觉检查,以评估初始和两个月存储后的粉末特性.
主要成果:
- 曼尼托尔在滴滴干燥过程中与白在表面丰富方面竞争,受辅助剂度和制造参数的影响.
- 由于竞争性核化,不总是可以实现改善粉末特性所需的晶体氨酸外.
- 配方中的初始氨酸和被确定为最终粉末特性的主要决定因素,类似于仅含氨酸的系统.
结论:
- 在喷雾干燥过程中,氨酸和曼尼托尔之间的相互作用显著影响了粒子形态和表面特性.
- 控制初始氨酸度对于实现理想的粉末特性和稳定的晶体表面外至关重要.
- 了解这些形成机制对于设计有效的吸入制药粉末至关重要.
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