Systematical approach of formulation and process development using roller compaction

被引:78
作者
Teng, Yue [1 ]
Qiu, Zhihui [1 ]
Wen, Hong [1 ]
机构
[1] Nova Pharmaceut Corp, Pharmaceut Dev Unit, E Hanover, NJ 07446 USA
关键词
Roller compaction; Formulation development; Process development; Dry granulation; PARTICLE-SIZE DISTRIBUTION; MICROCRYSTALLINE CELLULOSE; MERCURY POROSIMETRY; PORE STRUCTURE; ROLLING THEORY; TRUE DENSITY; TABLET; COMPRESSION; GRANULATION; POWDER;
D O I
10.1016/j.ejpb.2009.04.008
中图分类号
R9 [药学];
学科分类号
100702 [药剂学];
摘要
The roller compaction process has gained heightened interest in the pharmaceutical industry. In this review, common excipients and equipment used for dry granulation are described. Roller compaction process parameters and their impact on the critical quality attributes of the final product, as well as evaluation methods for roller compaction product such as ribbons and granules, are discussed. Overall, a systematical approach of formulation and process development has been proposed for excipient selection, critical process parameter identification, and necessary tests. (C) 2009 Elsevier B.V. All rights reserved.
引用
收藏
页码:219 / 229
页数:11
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