一种QbD方法,用于优化环胺单酸盐的冷化参数
Shaik Riyaz Ahammad1, Damodharan Narayanasamy1
1Department of Pharmaceutics, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur, India.
Drug development and industrial pharmacy
|April 1, 2025
概括
这项研究优化了使用"设计质量" (Quality by Design) 的环胺溶解,确保了单酸盐的稳定性. 开发的冷干燥技术保持了产品质量,并使其能够快速复制.
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:
- 环胺 (API) 的稳定性至关重要,特别是保持其单酸盐形式的化后.
- 解热化对于保持环胺单酸盐的稳定性至关重要.
研究的目的:
- 通过使用设计质量 (QbD) 来优化环胺单酸的关键冷化参数.
- 为了建立一个强大的和有效的冷化循环的环胺API.
主要方法:
- 进行了热分析,以评估产品的热性能.
- 通过设计质量 (QbD) 方法用于定义关键过程参数 (CPP) 和关键质量属性 (CQA).
- 包括初级干燥温度,持续时间和真空在内的冷化参数被系统地调查以定义设计空间.
主要成果:
- 优化的冷化过程成功地保持了环胺单水合物形式,由X射线衍射 (XRD) 证实.
- 产品的水含量保持在6-7%之间,TBA和ACN最小.
- 解凍產品呈現完整的蛋糕結構和快速復制時間 (<30秒).
结论:
- 通过设计 (QbD) 的质量原则有效地增强了对通用环胺配方的冷化参数优化.
- 开发了一种可靠的冷干燥技术,适合在工业规模的冷剂上进一步验证.
相关概念视频
Factors Influencing Drug Absorption: Pharmaceutical Parameters
112
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...
112
Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism
276
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...
276


