Pharmaceutical amorphous solid dispersion: A review of manufacturing strategies.

Pharmaceutical amorphous solid dispersion: A review of manufacturing strategies.
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DOI:
10.1016/j.apsb.2021.05.014
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发表时间:
2021-08
期刊:
Acta pharmaceutica Sinica. B
影响因子:
--
通讯作者:
Tony Zhou Q
Tony Zhou Q
中科院分区:
其他
文献类型:
--
作者:
Bhujbal SV;Mitra B;Jain U;Gong Y;Agrawal A;Karki S;Taylor LS;Kumar S;Tony Zhou Q

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无定形固体分散体(ASDs)在提高水溶性差药物的溶解度和生物利用度方面受到广泛欢迎。已有多种方法被用于制造自闭症谱系障碍,新技术也在不断涌现。本文综述了asd制备技术的最新进展。由于物理稳定性是ASD的关键质量属性,因此讨论了配方、设备和工艺变量以及下游加工对ASD物理稳定性的影响。提出了选择策略,以确定合适的制造方法,这可能有助于开发具有满意物理稳定性的asd。本文综述了非晶固体分散体(ASD)制造技术的最新进展。讨论了每种方法的制造变量和下游加工对asd临界物理稳定性的影响。
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. The review provides an updated overview of amorphous solid dispersion (ASD) manufacturing techniques. The impact of manufacturing variables of each method and downstream processing on the critical physical stability of ASDs are discussed.
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