Process Analytical Technology for continuous manufacturing of solid-dosage forms

被引：141

作者：

Fonteyne, Margot ^{[1
]}

Vercruysse, Jurgen ^{[2
]}

De Leersnyder, Fien ^{[1
]}

Van Snick, Bernd ^{[2
]}

Vervaet, Chris ^{[2
]}

Remon, Jean Paul ^{[2
]}

De Beer, Thomas ^{[1
]}

机构：

[1] Univ Ghent, Lab Pharmaceut Proc Analyt Technol, B-9000 Ghent, Belgium

[2] Univ Ghent, Lab Pharmaceut Technol, B-9000 Ghent, Belgium

来源：

TRAC-TRENDS IN ANALYTICAL CHEMISTRY | 2015年 / 67卷

关键词：

Continuous blending; Continuous pharmaceutical manufacturing; Direct compression; Near infrared; Particle-size analysis; Process analytical technology; Raman; Roller compaction; Spray drying; Twin-screw granulation; NEAR-INFRARED SPECTROSCOPY; MICROCRYSTALLINE CELLULOSE POWDER; ROLLER COMPACTION PROCESS; DRYING-MILLING PROCESS; BLENDING PROCESS; GRANULATION PROCESS; QUALITY ATTRIBUTES; RAMAN-SPECTROSCOPY; NIR SPECTROSCOPY; DRUG CONTENT;

D O I：

10.1016/j.trac.2015.01.011

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

Currently, pharmaceutical production is making the switch from batch processing towards continuous processing. The quality of intermediate and end products produced by batch processes is assured by off-line testing. It is obvious that off-line tests in analytical laboratories cancel out the advantages of continuous processing, so the critical quality attributes of continuously produced pharmaceuticals need to be monitored in real time. In 2004, the US Food and Drug Administration launched the process analytical technology (PAT) concept to stimulate the pharmaceutical industry to change from off-line to real-time quality testing. This review explores the implementation of PAT tools within continuous pharmaceutical processes (i.e., blending, spray drying, roller compaction, twin-screw granulation and compression), focusing on both opportunities and challenges. (C) 2015 Elsevier B.V. All rights reserved.

引用

页码：159 / 166

页数：8

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