Zhang Jie, Guo Minshan, Luo Minqian, Cai Ting
Department of Pharmaceutics, School of Pharmacy, China Pharmaceutical University, Nanjing 211198, China.
College of Biological and Chemical Engineering, Changsha University, Changsha 410022, China.
Asian J Pharm Sci. 2023 Jul;18(4):100834. doi: 10.1016/j.ajps.2023.100834. Epub 2023 Aug 1.
Amorphous solid dispersion (ASD) is one of the most effective approaches for delivering poorly soluble drugs. In ASDs, polymeric materials serve as the carriers in which the drugs are dispersed at the molecular level. To prepare the solid dispersions, there are many polymers with various physicochemical and thermochemical characteristics available for use in ASD formulations. Polymer selection is of great importance because it influences the stability, solubility and dissolution rates, manufacturing process, and bioavailability of the ASD. This review article provides a comprehensive overview of ASDs from the perspectives of physicochemical characteristics of polymers, formulation designs and preparation methods. Furthermore, considerations of safety and regulatory requirements along with the studies recommended for characterizing and evaluating polymeric carriers are briefly discussed.
无定形固体分散体(ASD)是递送难溶性药物最有效的方法之一。在ASD中,聚合物材料作为载体,药物以分子水平分散于其中。为制备固体分散体,有许多具有各种物理化学和热化学特性的聚合物可用于ASD制剂。聚合物的选择非常重要,因为它会影响ASD的稳定性、溶解度和溶解速率、制造工艺以及生物利用度。这篇综述文章从聚合物的物理化学特性、制剂设计和制备方法等角度对ASD进行了全面概述。此外,还简要讨论了安全性和监管要求的考量,以及用于表征和评估聚合物载体的推荐研究。