Near-infrared spectroscopic applications in pharmaceutical particle technology

被引:42
|
作者
Razuc, M. [1 ,2 ]
Grafia, A. [3 ]
Gallo, L. [2 ,3 ]
Ramirez-Rigo, M., V [2 ,3 ]
Romanach, R. J. [4 ]
机构
[1] Univ Nacl Sur, CONICET, Inst Quim Sur INQUISUR, Bahia Blanca, Buenos Aires, Argentina
[2] UNS, Dept Biol Bioquim & Farm, Bahia Blanca, Buenos Aires, Argentina
[3] UNS, CONICET, Planta Piloto Ingn Quim PLAPIQUI, Bahia Blanca, Buenos Aires, Argentina
[4] Univ Puerto Rico, Dept Chem, Ctr Struct Organ Particulate Syst, POB 9000, Mayaguez, PR 00682 USA
基金
美国国家科学基金会;
关键词
Particle technology; near-infrared spectroscopy; diffuse reflection; transmission; process analytical technology (PAT); chemometrics; continuous manufacturing; blend uniformity; NIR-CHEMOMETRIC METHODS; IN-LINE QUANTIFICATION; CONTINUOUS DIRECT COMPRESSION; SOLID-STATE CHARACTERIZATION; ACTIVE CONTENT DETERMINATION; CRITICAL QUALITY ATTRIBUTES; FLUIDIZED-BED GRANULATION; GEL MANUFACTURING PROCESS; POLYMER STRIP FILMS; 3090 FEED FRAME;
D O I
10.1080/03639045.2019.1641510
中图分类号
R914 [药物化学];
学科分类号
100701 ;
摘要
Near-infrared spectroscopy (NIRS) is nowadays an established analytical technique in the pharmaceutical industry. The aim of this review is to present the progress of NIRS in providing useful information for pharmaceutical particle technology. NIR methods are now developed to characterize a wide variety of materials (active pharmaceutical ingredients, excipients, co-processed powders, and physical mixtures) and pharmaceutical dosage forms (conventional, modified drug release technologies, and phytomedicines). This review also provides a number of spectra to illustrate the fundamental understanding of NIRS which has been gained. The sampling that must occur prior to the acquisition of near-infrared spectra is also discussed, as well as developments in monitoring mixing, tableting, and coating. This review will be valuable for product formulation and process engineering specialists.
引用
收藏
页码:1565 / 1589
页数:25
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