Comparison of the Design Space of Products with Different Initial Saturation

被引:0
作者
Luo, Chun [1 ]
Liu, Zhiqiang [1 ]
Mi, Sha [2 ]
Cai, Lingling [2 ]
Zhang, Zezong [1 ]
机构
[1] Cent South Univ, Sch Energy Sci & Engn, Changsha 410082M, Peoples R China
[2] China Univ Petr Beijing Karamay, Sch Engn, Karamay 834000, Xinjiang, Peoples R China
基金
中国国家自然科学基金;
关键词
Freeze drying; Design space; Prebuilt porosity; Mathematical model; Introduction; AQUEOUS MATERIAL FROZEN; POROUS-MEDIA; TRANSPORT; OPTIMIZATION; MODELS; IMPACT; BUILD; BATCH; PHASE; WATER;
D O I
10.1016/j.xphs.2021.09.034
中图分类号
R914 [药物化学];
学科分类号
100701 ;
摘要
Vacuum freeze-drying is a promising technology widely used in pharmaceuticals. Preparing products with prebuilt porosity has attracted considerable attention due to its potential in shortening process duration. However, the design space for the primary drying of initially unsaturated products remains unclear. A novel index, average power, was proposed in this paper to represents the collapse risk. And a multiphase model was employed in this paper to build the design space for the products with initial voids. The simulation results show that both the drying time and average power show higher sensitivity to the temperature variation than pressure. In addition, the initial saturation has significant impacts on the design space, with small initial saturation resulting in vast design space and vice versa, which implies that small initial saturation is more beneficial for the actual production. This paper would be helpful for the development of freeze-drying. (c) 2021 American Pharmacists Association. Published by Elsevier Inc. All rights reserved.
引用
收藏
页码:717 / 726
页数:10
相关论文
共 37 条
[1]  
ADAMS GDJ, 1993, J CHEM TECHNOL BIOT, V58, P71
[2]  
[Anonymous], 2009, GUID IND Q8 R2 PHARM
[3]   Application of the Quality by Design Approach to the Freezing Step of Freeze-Drying: Building the Design Space [J].
Arsiccio, Andrea ;
Pisano, Roberto .
JOURNAL OF PHARMACEUTICAL SCIENCES, 2018, 107 (06) :1586-1596
[4]   Understanding and optimization of the secondary drying step of a freeze-drying process: a case study [J].
Assegehegn, Getachew ;
de la Fuente, Edmundo Brito ;
Franco, Jose M. ;
Gallegos, Crispulo .
DRYING TECHNOLOGY, 2021, 39 (08) :1003-1017
[5]   An Experimental-Based Approach to Construct the Process Design Space of a Freeze-Drying Process: An Effective Tool to Design an Optimum and Robust Freeze-Drying Process for Pharmaceuticals [J].
Assegehegn, Getachew ;
Brito-de la Fuente, Edmundo ;
Franco, Jose M. ;
Gallegos, Crispulo .
JOURNAL OF PHARMACEUTICAL SCIENCES, 2020, 109 (01) :785-796
[6]   FREEZE-DRYING OF AQUEOUS-SOLUTIONS - MAXIMUM ALLOWABLE OPERATING TEMPERATURE [J].
BELLOWS, RJ ;
KING, CJ .
CRYOBIOLOGY, 1972, 9 (06) :559-561
[7]   Heat flux sensor to create a design space for freeze-drying development [J].
Carfagna, Marco ;
Rosa, Monica ;
Lucke, Matthias ;
Hawe, Andrea ;
Friess, Wolfgang .
EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS, 2020, 153 :84-94
[8]  
Chen M., P 18 INT DRYING S ID
[9]  
Estilarte M.L., LWT, V137
[10]   Computer-Aided Framework for the Design of Freeze-Drying Cycles: Optimization of the Operating Conditions of the Primary Drying Stage [J].
Fissore, Davide ;
Pisano, Roberto .
PROCESSES, 2015, 3 (02) :406-421