Solubilization studies of tadalafil (TDF) have recently improved the dissolution (%) using weak acids and bases in our group. However, the weak acid formulations have a low dissolution (%) of TDF as limitation. Thus, the purpose of this study was to improve the dissolution (%) of TDF over 90% in distilled water (DW) by weak acid-chitosan based multi-system. The SD formulation (SD11: TDF, tartaric acid, chitosan, Aerosil®200, and PVP/VA S-630 in a 1:2:1:1:2 weight ratio) showed higher dissolution (%) of TDF by 5.0-, 6.0-, and 5.8-fold at 60 min than that of Cialis® in DW and pH 1.2 and pH 6.8 buffers, respectively. The physical properties of the SD11 formulation were changed. Moreover, the SD11 formulation maintained stability for 3 months. In conclusion, the solubilization of TDF using chitosan was successfully performed for the first time.

他达拉非（TDF）的增溶研究最近在我们组中使用弱酸和弱碱提高了溶出度（％）。但是，弱酸制剂的TDF溶解度低（％）作为限制。因此，本研究的目的是通过基于弱酸-壳聚糖的多体系体系将TDF在蒸馏水（DW）中的溶解度（％）提高90％以上。SD配方（SD11：TDF，酒石酸，壳聚糖，Aerosil®200和PVP / VA S-630的重量比为1：2：1：1：2）显示出更高的TDF溶出度（％）为5.0-，在DW和pH 1.2和pH 6.8缓冲液中，在60分钟时分别比Cialis®分别高6.0倍和5.8倍。SD11配方的物理性质发生了变化。此外，SD11配方可保持3个月的稳定性。总之，首次成功地使用壳聚糖溶解了TDF。