评估不同包装形式的粉末注射中的次可见颗粒的颗粒大小分布 - - 小型次可见颗粒不应被忽视
Tao Wang1, Enhao Lu1, Qiwen Dai2
1Department of Pharmaceutics, School of Pharmacy, Key Laboratory of Smart Drug Delivery, Fudan University, Shanghai, China.
Drug development and industrial pharmacy
|August 30, 2023
概括
包装格式显著影响抗生素输注中的可见微粒水平. 双腔袋显示的颗粒 (<10微米) 比瓶子少,可能减少不良反应.
科学领域:
- 制药科学 制药科学
- 药物输送系统 药物输送系统
- 纳米技术 纳米技术
背景情况:
- 临床输液中的微小可见颗粒是关键的安全指标.
- 了解颗粒物分布对于评估输液安全性和解释不良反应至关重要.
研究的目的:
- 评估抗生素包装格式如何影响次可见颗粒分布 (<10微米).
- 提供临床不良反应的证据,并指导合理使用药物.
主要方法:
- 常规光阻塞和单颗粒光学传感 (SPOS) 用于分析颗粒大小分布.
- 扫描电子显微镜 (SEM) 用于检查粒子形态.
- 控制了活性药物成分 (API) 和溶剂的影响.
主要成果:
- 与瓶装相比,双腔袋中的注射粉具有显著较少的小微可见颗粒 (<10微米).
- SEM证实,在不规则形状的瓶装制剂中,颗粒物含量较高.
- 即使在对API进行控制后,差异仍然存在.
结论:
- 包装格式是次可见粒子分布差异的主要驱动因素.
- 双腔袋注射为缓解与颗粒物相关的不良反应提供了一个有希望的替代方案.
更多相关视频
10:10Three-Dimensional Particle Shape Analysis Using X-ray Computed Tomography: Experimental Procedure and Analysis Algorithms for Metal Powders
Published on: December 4, 2020
1.9K
04:59Author Spotlight: Developing a Disposable Dosator for Preclinical Testing of Dry Powder Inhalers in Small Animal Models
Published on: August 18, 2023
905
相关概念视频
Factors Affecting Dissolution: Particle Size and Effective Surface Area
887
Dissolution kinetics, an essential aspect of oral drug delivery, is significantly influenced by the drug's particle size. According to the Noyes-Whitney dissolution model, the dissolution rate correlates directly with the drug's surface area. The larger the surface area, the higher the drug's solubility in water, leading to a faster drug dissolution rate. Reducing particle size increases the effective surface area, enhancing the dissolution process. Micronization and nanosizing are...
887
Precipitate Formation and Particle Size Control
813
In precipitation gravimetry, the precipitating agent should react specifically or selectively with the analyte. While a specific reagent reacts with the analyte alone, a selective reagent can react with a limited number of chemical species.
The obtained precipitate should be either a pure substance of known composition or easily converted to one by a simple process, such as ignition or drying. In addition, the precipitate should be insoluble and easily filterable. In general, filterability...
The obtained precipitate should be either a pure substance of known composition or easily converted to one by a simple process, such as ignition or drying. In addition, the precipitate should be insoluble and easily filterable. In general, filterability...
813
Size-Exclusion Chromatography
641
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,...
641
