通过加强药品活性成分的持续过干燥进行质量控制
Francesco Destro1,2, Massimiliano Barolo1, Zoltan K Nagy2
1CAPE-Lab-Computer-Aided Process Engineering Laboratory, Department of Industrial Engineering, University of Padova, Padova, Italy.
概括
本研究引入了用于连续制药制造的闭环质量控制框架,通过基于模型的控制提高了产品的一致性和生产率. 它推进了现代药物生产的质量控制原则.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 工艺控制工程 工艺控制工程
- 化学工程是化学工程的重要组成部分.
背景情况:
- 连续制造和闭环质量控制是现代化制药生产的关键.
- 目前的制药制造往往依赖于开放循环系统,限制实时质量保证.
- 结晶泥的综合过干燥对控制提出了复杂的挑战.
研究的目的:
- 开发和评估一种用于连续制药制造中的集成过干燥的新型工艺控制框架.
- 实施一个分层的,三层质量通过控制 (QbC) 系统.
- 为了证明闭环,基于模型的控制对传统方法的优势.
主要方法:
- 开发基于模型的监控和控制系统,包括状态估计和实时优化.
- 在ContCarSim旋转木马模拟器中实现控制系统.
- 与更简单的控制策略和开放循环操作进行基准测试.
主要成果:
- 拟议的闭环控制系统显著改善了产品质量的一致性.
- 与开放循环系统相比,控制框架导致制造业生产率提高.
- 在QbC框架内,基于模型的技术在制药加工中被证明是优越的.
结论:
- 开发的控制框架对于制药制造中的连续过-干燥过程是有效的.
- 这项工作支持向端到端连续制药加工的过渡.
- 该研究强调了从质量设计到更强大的质量控制模式的演变.
更多相关视频
相关概念视频
Filtration
821
Filtration is a physical separation process that involves passing a suspension through a porous medium to separate solids from fluids. During filtration, solids collect on the porous medium while liquids, also collectively known as the filtrate, pass through. The filtration medium is selected based on the filtration purpose, quantity, and nature of the precipitate. The general criteria for a suitable filtering medium are that it is inert, mechanically strong, nonabsorbent toward dissolved...
821
Factors Influencing Drug Absorption: Pharmaceutical Parameters
133
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...
133
Dialysis
653
Dialysis is a diffusion-based purification process that separates analyte molecules from a complex matrix. This is accomplished by allowing molecules in the solution to pass through a semipermeable membrane into a liquid on the other side. The membrane is usually made of cellulose acetate or cellulose nitrate, and the second liquid must be miscible with the solution. Ions (e.g., chloride or sodium) or organic molecules (e.g., glucose) can pass through the membrane pores, which generally have...
653


