表面差异异性对纤维化晶体习惯溶解行为的影响:使用USP2型和4型溶解装置进行比较研究
Sakshi M Shah1, Soumalya Chakraborty1, Gurudutt Dubey2
1Solid State Pharmaceutics Laboratory, Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research (NIPER), S.A.S. Nagar, Punjab 160062, India.
水晶习惯显著影响活性药物成分 (API) 溶解. 板状FEN晶体由于不同的表面特性而表现出比杆状晶体更好的溶解,突出了晶体习惯作为一种关键材料属性.
科学领域:
- 制药科学 制药科学
- 固态化学 固态化学
- 晶体学 晶体学是指结晶学.
背景情况:
- 活性药物成分 (API) 的固态特性极大地影响了它们的溶解性能.
- 水晶习惯,固态性质的表现,可以影响药物的生物可用性.
- 了解晶体习惯的影响对于一致的药物配方至关重要.
研究的目的:
- 为了评估杆 (FEN-R) 和板 (FEN-P) 的溶解概况,I型FEN的晶体习惯.
- 研究FEN-R和FEN-P之间的不同溶解性能的分子基础.
- 为了比较USP类型2和类型4溶解装置的分辨力.
主要方法:
- 抗溶剂结晶被用来产生形式I FEN的杆状和板状晶体习惯.
- 使用USP类型2和类型4装置评估溶解概况.
- 使用晶体面索引,静电电位 (ESP) 映射和能量框架分析来了解分子差异.
主要成果:
- 与FEN-R相比,FEN-P表现出更高的溶解性能,尽管具有相似的多态形状和颗粒大小分布.
- 在FEN-R中,占主导的 (001) 面是疏水的 (甲部分),而在FEN-P中占主导的 (01-1) 面是疏水的 (和甲基组).
- 与USP Type 2相比,USP Type 4装置在检测由晶体习惯引起的溶解差异方面表现出更好的区分能力.
结论:
- 晶体习惯是一种关键材料属性 (CMA),显著影响FEN溶解.
- 主导晶体面的表面水友性/水性决定了溶解行为.
- 适当选择溶解测试仪器对于将体外性能与体外结果关联起来至关重要.
更多相关视频
11:48Microfluidic Chips for In Situ Crystal X-ray Diffraction and In Situ Dynamic Light Scattering for Serial Crystallography
Published on: April 24, 2018
06:26Orientational Transition in a Liquid Crystal Triggered by the Thermodynamic Growth of Interfacial Wetting Sheets
Published on: May 15, 2017
相关概念视频
Factors Affecting Dissolution: Particle Size and Effective Surface Area
Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism
Some polymorphic crystals possess lower aqueous solubility than their amorphous counterparts, leading to incomplete absorption. For instance, the oral suspension of Chloramphenicol, which...
Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry
Theories of Dissolution: The Danckwerts' Model and Interfacial Barrier Model
Theories of Dissolution: Diffusion Layer Model
This process starts with a thin layer, saturated with the drug, forming at the interface between the solid and liquid. The solute then diffuses from this layer into the main solution. The Noyes-Whitney equation suggests that the rate of dissolution relies on the diffusion...
Factors Influencing Drug Absorption: Drug Dissolution
