四种药典测量粉末流动性的方法的系统比较
Weeraya Tharanon1, Yiwang Guo2, Jomjai Peerapattana1
1Division of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, Khon Kaen University, Khon Kaen 40002, Thailand.
International journal of pharmaceutics
|July 10, 2024
概括
评估制药粉末的流动性是高效制造的关键. 这项研究比较了四种方法,发现多种技术是全面表征的最佳方法,特别是对于具有不同流动性质的粉末.
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:
- 粉末的流动性对制药制造效率和产品质量产生重大影响.
- 美国药典概述了评估粉末流动的四种主要方法:静止角度 (AoR),压缩性指数 (CI) 和豪斯纳比 (HR),通过孔径流动和剪切细胞分析.
- 这些方法的比较分析对于选择适当的粉末表征技术至关重要.
研究的目的:
- 系统地比较四种常见粉末流动性评估方法的性能.
- 为了确定不同方法在广泛的粉末流动特性之间之间的相关性.
- 为选择最合适的药用粉末表征方法提供指导.
主要方法:
- 使用了21种不同的制药粉末,流动性各不相同.
- 进行了对静止角 (AoR),压缩性指数 (CI) /豪斯纳比 (HR),穿过孔径 (最小直径,dmin) 的流量和剪切细胞方法的比较分析.
- 在每个方法中,从不同的仪器和测量技术中获得的相关结果.
主要成果:
- 观察到AoR测量的不同变化 (R2 = 0.939) 和通过不同的点击方法获得的CI/HR值 (R2 > 0.9) 之间存在强烈的相关性.
- AoR,CI/HR,dmin和剪切细胞方法显示,对于流动性较差的粉末 (比Avicel® PH102更糟糕) 有很强的相关性.
- 剪切细胞和CI/HR方法有效区分流动不良的粉末,而AoR和CI/HR在区分流动良好的粉末方面优越.
结论:
- 没有任何一种方法是普遍优越的,用于表征所有类型的粉末流动性.
- 剪切细胞和CI/HR方法是可靠的,用于识别薄弱的粉末流量.
- 对于全面的粉末流量表征,特别是在广泛的流量特性范围内,建议使用多种互补技术.
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