The aim of the present study was to determine whether solid dispersions (SDs) are applicable to gummi formulations. Amenamevir was selected as a model of a poorly water-soluble drug, and polyvinyl alcohols (PVAs) with various degrees of hydrolysis (PVA 66, PVA 80, PVA 88, and PVA 66/88) were used as SD carriers. Design of experiments (DOE) was used to develop a gummi formulation that was suitable for an amenamevir SD using SD with PVA 66. Dissolution studies and clinical sensory tests on 11 formulations calculated by DOE revealed that a gummi formulation comprising 10.5% gelatin and 22.8% water was suitable for SD of the drug. Gummi formulations comprising amenamevir SDs with various PVAs were prepared using the determined gummi formulation, and their ability to dissolve amenamevir, their stability, and their oral absorption in dogs were evaluated. The results suggested that PVA 66, PVA 66/88, and PVA 80 were appropriate in terms of dissolution, stability, and in vivo absorption, respectively. Considering these results comprehensively, it was concluded that PVA 80, which enabled the highest degree of absorption, was the most suitable SD carrier for gummi formulations. Thus, it was possible to apply a PVA SD of amenamevir to gummi formulations.

本研究的目的是确定固体分散体 (SD) 是否适用于软糖配方。选择阿美那韦作为难溶性药物的模型，不同水解度的聚乙烯醇 (PVA) (PVA 66、PVA 80、PVA 88 和 PVA 66/88) 用作 SD 载体。实验设计 (DOE) 用于开发适用于使用 SD 和 PVA 66 的阿美那韦 SD 的软糖配方。 DOE 计算的 11 种配方的溶出度研究和临床感官测试表明，软糖配方包含 10.5% 的明胶和 22.8% 的明胶水适合药物的SD。使用确定的树胶制剂制备包含阿美那韦 SD 和各种 PVA 的胶制剂，并评估它们溶解阿美那韦的能力、稳定性和它们在狗中的口服吸收。体内吸收，分别。综合考虑这些结果，得出的结论是，吸收度最高的 PVA 80 是最适合口香糖配方的 SD 载体。因此，可以将阿美那韦的 PVA SD 应用于软糖配方。