Abstract:
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.
摘要:
无定形固体分散体(ASD)是用于递送难溶性药物的最有效方法之一。在ASD中,聚合物材料作为载体,药物在分子水平上分散在其中。为了制备固体分散体,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。聚合物的选择是非常重要的,因为它影响稳定性,溶解度和溶解速率,制造过程,和ASD的生物利用度。这篇综述文章从聚合物的物理化学特性的角度对ASD进行了全面的概述,配方设计和制备方法。此外,简要讨论了安全性和监管要求的考虑因素,以及推荐用于表征和评估聚合物载体的研究。