Amorphous solid dispersion to facilitate the delivery of poorly water-soluble drugs: recent advances on novel preparation processes and technology coupling.

Chengxiang Luo, Ruipeng Li, Mi Tang, Yuan Gao, Jianjun Zhang, Shuai Qian, Yuanfeng Wei, Peiya Shen
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Abstract

Introduction: Amorphous solid dispersion (ASD) technique has recently been used as an effective formulation strategy to significantly improve the bioavailability of insoluble drugs. The main industrialized preparation methods for ASDs are mainly hot melt extrusion and spray drying techniques; however, they face the limitations of being unsuitable for heat-sensitive materials and organic reagent residues, respectively, and therefore novel preparation processes and technology coupling for developing ASDs have received increasing attention.

Areas covered: This paper reviews recent advances in ASD and provides an overview of novel preparation methods, mechanisms for improving drug bioavailability, and especially technology coupling.

Expert covered: As a mature pharmaceutical technology, ASD has broad application prospects and values. During the period from 2012 to 2024, the FDA has approved 49 formulation products containing ASDs. However, with the diversification of drug types and clinical needs, the traditional formulation technology of ASDs is gradually no longer sufficient to meet the needs of clinical medication. Therefore, this review summarizes the studies on both novel preparation processes and technology combinations; and provides a comprehensive overview of the mechanisms of ASD to improve drug bioavailability, in order to better select appropriate preparation methods for the development of ASD formulations.

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无定形固体分散体促进水溶性差药物的输送:新型制备工艺和技术耦合的最新进展。
导言:无定形固体分散体(ASD)技术近来已被用作一种有效的制剂策略,可显著提高难溶性药物的生物利用度。非晶态固体分散体的主要工业化制备方法是热熔挤出和喷雾干燥技术,但这两种方法分别面临着不适合热敏性材料和有机试剂残留的局限性,因此开发非晶态固体分散体的新型制备工艺和技术耦合日益受到关注:本文回顾了 ASD 的最新进展,概述了新型制备方法、提高药物生物利用度的机制,特别是技术耦合:作为一项成熟的制药技术,ASD 具有广阔的应用前景和价值。从2012年到2024年,FDA已经批准了49个含有ASD的制剂产品。然而,随着药物种类和临床需求的多样化,传统的ASD制剂技术已逐渐不能满足临床用药的需求。因此,本综述总结了新型制备工艺和技术组合两方面的研究;全面概述了ASD提高药物生物利用度的机理,以便更好地为ASD制剂的开发选择合适的制备方法。
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