Bhujbal Sonal V, Mitra Biplob, Jain Uday, Gong Yuchuan, Agrawal Anjali, Karki Shyam, Taylor Lynne S, Kumar Sumit, Tony Zhou Qi
Department of Industrial and Physical Pharmacy, College of Pharmacy, Purdue University, West Lafayette, IN 47907, USA.
Oral Product Development, Bristol Myers Squibb, Summit, NJ 07901, USA.
Acta Pharm Sin B. 2021 Aug;11(8):2505-2536. doi: 10.1016/j.apsb.2021.05.014. Epub 2021 Jun 5.
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.
无定形固体分散体(ASDs)在提高难溶性药物的溶解度和生物利用度方面很受欢迎。人们已经采用了各种方法来制备ASDs,并且新技术不断涌现。本文综述提供了制备ASDs的制造技术的最新概述。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ASDs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令人满意物理稳定性的ASDs。