Pharmaceutical amorphous solid dispersion: A review of manufacturing strategies

被引：325

作者：

V. Bhujbal, Sonal ^{[1
]}

Mitra, Biplob ^{[2
]}

Jain, Uday ^{[3
]}

Gong, Yuchuan ^{[2
]}

Agrawal, Anjali ^{[2
]}

Karki, Shyam ^{[2
]}

Taylor, Lynne S. ^{[1
]}

Kumar, Sumit ^{[2
]}

Zhou, Qi ^{[1
]}

机构：

[1] Purdue Univ, Dept Ind & Phys Pharm, Coll Pharm, W Lafayette, IN 47907 USA

[2] Bristol Myers Squibb, Oral Prod Dev, Summit, NJ 07901 USA

[3] Bristol Myers Squibb, Mat Sci & Engn, Summit, NJ 07901 USA

来源：

ACTA PHARMACEUTICA SINICA B | 2021年 / 11卷 / 08期

基金：

比尔及梅琳达.盖茨基金会; 美国国家卫生研究院;

关键词：

Amorphous solid dispersions; Stability; Drug delivery; Manufacturing; Solvent evaporation; Melting process; Co-precipitation; Downstream processing; Selection criteria; HOT-MELT EXTRUSION; WATER-SOLUBLE DRUGS; IN-VIVO EVALUATION; PARTICLE ENGINEERING TECHNOLOGY; SPRAY-DRYING PROCESS; BIOPHARMACEUTICAL CLASSIFICATION-SYSTEM; GLASS-TRANSITION TEMPERATURE; PHYSICAL STABILITY; SOLUBILITY ENHANCEMENT; DISSOLUTION-RATE;

D O I：

10.1016/j.apsb.2021.05.014

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Amorphous solid dispersions (ASDs) are popular for enhancing the solubility and bioavailability of poorly water-soluble drugs. Various approaches have been employed to produce ASDs and novel techniques are emerging. This review provides an updated overview of manufacturing techniques for preparing ASDs. As physical stability is a critical quality attribute for ASD, the impact of formulation, equipment, and process variables, together with the downstream processing on physical stability of ASDs have been discussed. Selection strategies are proposed to identify suitable manufacturing methods, which may aid in the development of ASDs with satisfactory physical stability. (C) 2021 Chinese Pharmaceutical Association and Institute of Materia Medica, Chinese Academy of Medical Sciences. Production and hosting by Elsevier B.V.

引用

页码：2505 / 2536

页数：32

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