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KMID : 1146920180480010019
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Journal of Pharmaceutical Investigation
2018 Volume.48 No. 1 p.19 ~ p.41
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Characterization of amorphous solid dispersions
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Liu Xu
Feng Xin
WilliamsIII Robert O.
Zhang Feng
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Abstract
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The study of amorphous solid dispersions (ASDs) is currently one of the most exciting areas in pharmaceutics. Research has shown that ASDs offer unique advantages in improving the bioavailability of poorly water-soluble drugs over conventional delivery systems. The various formulations and manufacturing processes of ASDs affect their physicochemical stability, processability, and drug release characteristics. Therefore, the characterization of ASDs is critical in all stages of product development, including preformulation screening, formulation development, process scale-up, and commercial manufacturing. Proper characterization allows for the rational selection of formulation composition and manufacturing processing methods and allows for high-quality drug products. In this review, we present the most commonly used methods for characterizing the solid-state properties of ASDs, and we discuss their mechanisms, applications, advantages, and disadvantages. We also provide a brief overview of the methods used to characterize ASDs behavior in aqueous media. These methods are divided into three different categories: microscopic and surface analysis methods, thermal analysis methods, and spectroscopic methods. In addition, this article discusses a number of emerging techniques. Last, we discuss how these methods are applied at different stages in the ASDs product development life cycle.
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KEYWORD
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Amorphous solid dispersion, Material characterization, Physical stability, Phase separation, Molecular mobility, Microscopic analysis, Thermal analysis, Spectroscopic analysis
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