Loss-in-Weight Feeding Trials Case Study: Pharmaceutical Formulation

被引:87
作者
Engisch, William E. [1 ]
Muzzio, Fernando J. [1 ]
机构
[1] Rutgers State Univ, Dept Chem & Biochem Engn, Piscataway, NJ 08854 USA
关键词
Continuous processing; Secondary manufacturing; Loss-in-weight feeders; Pharmaceutical formulation; POWDER; BATCH; FLOW;
D O I
10.1007/s12247-014-9206-1
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
This article presents a case study of a continuous feeding strategy for five pharmaceutical components (active pharmaceutical ingredient (API), Prosolv HD90, crospovidone, magnesium stearate, and colloidal silicon dioxide), for the purpose of developing a direct compression continuous manufacturing system. Feeding options for each of these five powders were examined. Prosolv HD90 and crospovidone easily resulted in optimal feeding conditions, whereas the remaining powders in the formulation presented some challenges. The API displayed flow issues, leading to clogging of the screen with small openings. Magnesium stearate exhibited shear sensitivity; increasing shear of the powder due to hopper agitation resulted in drifting feeding performance. Colloidal silicon dioxide exhibited electrostatic issues that render most tooling options unsuitable for steady operation. All of these difficulties were resolved using the methods described in this article.
引用
收藏
页码:56 / 75
页数:20
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