工艺诱导的晶体表面异质性和对奥达纳卡提布粉末性能的影响
Isha Bade1, Vikram Karde1, Luke Schenck2
1Department of Chemical Engineering, South Kensington Campus, Imperial College London, London SW7 2AZ, UK.
Pharmaceutics
|July 27, 2024
概括
处理史显著影响活性药物成分的表面特性,影响药物产品的性能. 了解表面化学和能量是预测药物稳定性和溶解的关键.
科学领域:
- 制药科学 制药科学
- 材料科学 材料科学 材料科学
- 物理化学 物理化学
背景情况:
- 晶体活性药物成分 (API) 由于结晶或磨等制造工艺,可以表现出表面异质性.
- 表面的特性,如化学,能量和可湿性,会影响散装粉末的特性.
- 这些散装特性反过来影响药物产品的关键性能指标,包括稳定性,溶解性,流动性和分散性.
研究的目的:
- 为了研究不同的制造工艺 (喷射磨与快速沉) 如何影响Odanacatib批次的表面特性.
- 为了将观察到的粒子表面特性差异与散装粉末特征的变化相关联.
- 证明直角表面分析技术在理解加工诱导的表面修饰方面的实用性.
主要方法:
- 利用逆气色谱 (IGC) 来评估表面的能量和化学.
- 采用布鲁努埃尔-埃梅特-泰勒 (BET) 分析来确定表面积.
- 测量接触角度用于湿度评估.
- 应用X射线光电子光谱 (XPS) 用于表面化学特性.
- 通过喷射加工和各种溶剂的快速沉处理的Odanacatib的比较批量.
主要成果:
- 不同的加工历史 (喷射磨与快速降水) 导致Odanacatib批次的表面性能不同,尽管满足了颗粒大小规格.
- 表面异质性是显而易见的,并受到制造途径的影响.
- 整体而言,直角表面技术在加工历史和表面特征之间显示出了显著的相关性.
- 这些表面特性变化与在散装粉末特性中观察到的差异有关.
结论:
- 颗粒处理历史是晶体API如Odanacatib.的表面特性的一个关键决定因素.
- 由制造引发的表面异质性显著影响散装粉末的行为,并因此影响药物产品的性能.
- 通过直角分析方法实现的表面特性的全面理解,对于预测和控制药物产品的质量和性能至关重要.
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