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喷雾干燥法制备难溶性药物固体分散体:制剂与工艺考虑。

Manufacturing of solid dispersions of poorly water soluble drugs by spray drying: formulation and process considerations.

机构信息

Laboratory of Pharmacotechnology and Biopharmacy, KU Leuven, Leuven, Belgium.

出版信息

Int J Pharm. 2013 Aug 30;453(1):253-84. doi: 10.1016/j.ijpharm.2012.07.015. Epub 2012 Jul 20.

Abstract

Spray drying is an efficient technology for solid dispersion manufacturing since it allows extreme rapid solvent evaporation leading to fast transformation of an API-carrier solution to solid API-carrier particles. Solvent evaporation kinetics certainly contribute to formation of amorphous solid dispersions, but also other factors like the interplay between the API, carrier and solvent, the solution state of the API, formulation parameters (e.g. feed concentration or solvent type) and process parameters (e.g. drying gas flow rate or solution spray rate) will influence the final physical structure of the obtained solid dispersion particles. This review presents an overview of the interplay between manufacturing process, formulation parameters, physical structure, and performance of the solid dispersions with respect to stability and drug release characteristics.

摘要

喷雾干燥是一种用于固体分散体制备的高效技术,因为它允许极快速的溶剂蒸发,从而使 API-载体溶液迅速转化为固体 API-载体颗粒。溶剂蒸发动力学确实有助于形成无定形固体分散体,但其他因素,如 API、载体和溶剂之间的相互作用、API 的溶液状态、配方参数(例如进料浓度或溶剂类型)和工艺参数(例如干燥气体流速或溶液喷雾速率)也会影响最终获得的固体分散颗粒的物理结构。本文综述了制备工艺、配方参数、物理结构和固体分散体性能之间的相互关系,特别是它们对稳定性和药物释放特性的影响。

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