在直接压缩过程中分离配方粉末,并通过小型测试台测试器进行评估
Tong Deng1, Lucas Massaro Sousa2, Vivek Garg1
1Wolfson Centre for Bulk Solids Handling Technology, Faculty of Engineering & Science, University of Greenwich, Central Avenue, Chatham ME4 4TB, UK.
International journal of pharmaceutics
|October 23, 2023
概括
制药制造中的粉末分离是一个挑战. 小型实验室规模测试器有效预测分离强度,帮助制定决策和流程优化.
科学领域:
- 制药科学 制药科学
- 化学工程是化学工程的重要组成部分.
- 材料科学 材料科学 材料科学
背景情况:
- 粉末分离给制药制造中的含量统一带来了重大挑战,特别是对于自由流动的粉末.
- 在早期配方阶段评估分离强度是很困难的,因为样本的可用性有限.
- 早期隔离评估的新方法对于流程优化至关重要.
研究的目的:
- 为了研究小型测试台规模测试器对评估粉末分离的实用性.
- 为了比较测试台规模测试器的预测准确度与试点模拟过程设备.
- 探索线性回归模型用于预测过程分离的潜力.
主要方法:
- 研究了8种粉末配方,包括联合加工的辅助剂和不同比例的活性药物成分.
- 隔离强度是用两种台式测试仪测量:一种是空气诱导的,另一种是表面滚动隔离测试仪.
- 对一个试点模拟过程装置进行了比较分析.
主要成果:
- 基板尺度测试器可提供可靠的分离强度指示,用于高达20%分离的混合物.
- 这两种实验室测试仪都与试点工艺设备有很好的相关性.
- 这些发现表明,任何一个隔离测试器都可以独立地用于评估.
结论:
- 小规模分离测试仪是药物配方开发早期阶段的宝贵工具.
- 这些测试器提供了一种实用和可靠的方法来预测过程分离,并告知操作条件.
- 该研究支持空气诱导和表面滚动测试仪在隔离评估中的独立使用.
相关概念视频
Segregation in Fresh Concrete
146
Segregation in fresh concrete is a phenomenon where the components of the concrete mix separate, leading to uneven distribution and compromised structural integrity. This separation typically occurs when concrete is subjected to excessive horizontal movement within forms, or when it is dropped from considerable heights or forced through narrow, winding paths. As a result, heavier coarse aggregate particles settle at the bottom, while lighter, finer materials such as cement and water rise to the...
146
Centrifugation
2.3K
Centrifugation is a separation technique based on differences in density or size. It is commonly used to separate solids from aqueous interferents. During centrifugation, the sample is placed in centrifugation tubes and spun at high angular velocity, which allows centrifugal force to act differentially on the different densities or masses of the components. After spinning, the supernatant liquid is decanted. Depending on the specific application, either the pellet or the supernatant is retained...
2.3K
Design Example: Aggregate Gradation
98
The right type and quality of aggregates are crucial for concrete as they significantly influence its properties, mix proportions, and cost-effectiveness. If different sources are available for sand, the commonly used fine aggregate in concrete, the selection of sand is primarily based on its gradation.
The grading, or particle-size distribution, of sand is determined using sieve analysis, with standard sizes ranging from 150 μm to 10 mm (ASTM No. 100 sieve to 3⁄8 in. sieve). Sand is...
The grading, or particle-size distribution, of sand is determined using sieve analysis, with standard sizes ranging from 150 μm to 10 mm (ASTM No. 100 sieve to 3⁄8 in. sieve). Sand is...
98
Size-Exclusion Chromatography
616
In size-exclusion chromatography (SEC), also known as molecular-exclusion or gel-permeation chromatography, molecules are separated based on their sizes. This technique is important for separating large molecules such as polymers and biomolecules. The two classes of micron-sized stationary phases encountered in SEC are silica particles and cross-linked polymer resin beads. Both materials are porous, but their pore sizes vary significantly.
Silica particles offer advantages such as rigidity,...
Silica particles offer advantages such as rigidity,...
616


