Application of the Quality by Design Principles for the Development of the Crystallization Process for a Piperazinyl-Quinoline and Definition of the Control Strategy for Form 1

被引:2
|
作者
Cimarosti, Zadeo [1 ]
Rossi, Sara [1 ]
Tramarin, Davide [1 ]
Laval, Gilles [1 ]
Stabile, Paolo [1 ]
Giubellina, Nicola [1 ]
Maton, William [1 ]
Allieri, Brigida [2 ]
Campi, Francesca [2 ]
Cooke, Jason [3 ]
Westerduin, Pieter [1 ]
机构
[1] GlaxoSmithKline Med Res Ctr, Chem Dev, I-37135 Verona, Italy
[2] GlaxoSmithKline Med Res Ctr, Pharmaceut Dev, I-37135 Verona, Italy
[3] GlaxoSmithKline, Med Res Ctr, Chem Dev, Stevenage, Herts, England
关键词
ANTIDEPRESSANTS; DERIVATIVES; DIHYDRATE;
D O I
10.1021/op300126e
中图分类号
O69 [应用化学];
学科分类号
081704 ;
摘要
The studies carried out to develop a robust crystallization method for the substituted piperazinyl-quinoline (1) a compound potentially active in the treatment of depression, are described in this contribution. These studies include the control of a solvate that could have potentially formed in the crystallization process. The principles of quality by design (QbD) were applied to generate the process understanding and to define the control strategy for the control of the formation of the solvate during the crystallization. The application of process analytical technology (PAT) tools was key in achieving the desired process control.
引用
收藏
页码:1598 / 1606
页数:9
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