湿颗粒化共形印梅他辛系统的湿颗粒化
David Schütz1, Annika Timmerhaus1, Holger Grohganz1
1Department of Pharmacy, University of Copenhagen, Copenhagen, Denmark.
International journal of pharmaceutics
|August 16, 2023
概括
与微晶纤维素 (MCC) 共同形态药物系统的湿颗粒化是可行的. 基于氨酸的共同形态配方在湿颗粒后保持稳定,表明可扩展药物递送系统的潜力.
科学领域:
- 制药技术 制药技术 制药技术
- 材料科学 材料科学 材料科学
- 药物运输 药物运输 药物运输
背景情况:
- 同形态系统可以提高药物的溶解性和生物可用性.
- 通过湿颗粒处理研究共形系统的可加工性对于制药制造至关重要.
研究的目的:
- 评估与微晶纤维素 (MCC) 共形药物氨基酸系统的湿颗粒的可行性.
- 评估在湿颗粒处理期间和之后同形配方的物理稳定性.
主要方法:
- 同形的药物-氨基酸系统 (印度甲-酸和印度甲-氨酸) 通过球磨来制备.
- 使用X射线粉末衍射 (XRPD),差分扫描热度计 (DSC) 和富里埃转换红外光谱 (FTIR) 进行固态特征化.
- 使用MCC和高剪切混合机中的水进行小型化和扩大规模的湿颗粒加工.
主要成果:
- 含托的系统表现出再结晶,表明不稳定.
- 含有氨酸的共同形态系统在10个多月内保持不变形.
- 对于大多数基于氨酸的配方,成功实现了湿颗粒化,稳定性至少维持了十二周.
- 重结晶发生在一个低MCC比率的配方在艰难的条件下,在扩大规模.
结论:
- 特定的共形系统的湿颗粒化,特别是那些含有氨酸的系统,是一种可行的制造工艺.
- 配方成分和粒度参数影响共形系统的物理稳定性.
- 当保持稳定性时,共形态系统显示出可扩展的制药生产的前景.
更多相关视频
12:22Synthesis of Thermogelling PolyN-isopropylacrylamide-graft-chondroitin Sulfate Composites with Alginate Microparticles for Tissue Engineering
Published on: October 26, 2016
11.9K
10:18Fragmenting Bulk Hydrogels and Processing into Granular Hydrogels for Biomedical Applications
Published on: May 17, 2022
5.7K
相关概念视频
Factors Influencing Drug Absorption: Pharmaceutical Parameters
154
Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
154
Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism
336
Polymorphism refers to the existence of a drug substance in multiple crystalline forms, known as polymorphs. Recently, this term has been expanded to include solvates (forms containing a solvent), amorphous forms (non-crystalline forms), and desolvated solvates (forms from which the solvent has been removed).
Some polymorphic crystals possess lower aqueous solubility than their amorphous counterparts, leading to incomplete absorption. For instance, the oral suspension of Chloramphenicol, which...
Some polymorphic crystals possess lower aqueous solubility than their amorphous counterparts, leading to incomplete absorption. For instance, the oral suspension of Chloramphenicol, which...
336
Factors Affecting Dissolution: Particle Size and Effective Surface Area
889
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...
889
Colloidal precipitates
622
The high insolubility of some precipitates can result in an unfavorable relative supersaturation. This can lead to colloidal particles with a large surface-to-mass ratio, where adsorption is promoted. For instance, in the precipitation of silver chloride, silver ions are adsorbed on the surface of the colloidal particles, forming a primary layer. This layer attracts ions of opposite charge (such as nitrate ions), forming a diffuse secondary layer of adsorbed ions. This electric double layer...
622
