Process Analytical Technologies (PAT) in freeze-drying of parenteral products

被引：41
作者：
Patel, Sajal Manubhai [1 ]
Pikal, Michael [1 ]
机构：
[1] Univ Connecticut, Mansfield Ctr, Sch Pharm, Dept Pharmaceut Sci, Storrs, CT 06250 USA
来源：
PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY | 2009年 / 14卷 / 06期
关键词：
Freeze-drying; PAT; online monitoring techniques; QbD; process development; MANOMETRIC TEMPERATURE-MEASUREMENT; LYOPHILIZED PROTEIN FORMULATIONS; NEAR-INFRARED METHODS; MASS-TRANSFER; PHARMACEUTICAL PROTEINS; RESIDUAL MOISTURE; RATIONAL DESIGN; ICE MORPHOLOGY; HEAT-TRANSFER; SUBLIMATION;
D O I：
10.3109/10837450903295116
中图分类号：
R9 [药学];
学科分类号：
1007 ;
摘要：
Quality by Design (QbD), aims at assuring quality by proper design and control, utilizing appropriate Process Analytical Technologies (PAT) to monitor critical process parameters during processing to ensure that the product meets the desired quality attributes. This review provides a comprehensive list of process monitoring devices that can be used to monitor critical process parameters and will focus on a critical review of the viability of the PAT schemes proposed. R&D needs in PAT for freeze-drying have also been addressed with particular emphasis on batch techniques that can be used on all the dryers independent of the dryer scale.
引用
收藏
页码：567 / 587
页数：21
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