Sisopa Premnapa, Lamlertthon Supaporn, Kaomongkolgit Ruchadaporn, Chomchalao Pratthana, Tiyaboonchai Waree
Department of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok 65000, Thailand.
Department of Health and Cosmetic Product Development, Faculty of Food and Agricultural Technology, Pibulsongkram Rajabhat University, Phitsanulok 65000, Thailand.
Pharmaceutics. 2025 Apr 23;17(5):546. doi: 10.3390/pharmaceutics17050546.
This study aimed to develop and characterize the physicochemical properties of a self-emulsion drug delivery system (SNEDDS) incorporating galangal extract (GE) and lemongrass oil (LGO). Then, to develop mouthwash powders containing GE- and LGO-loaded SNEDDS (GL-mouthwash powder) as a promising alternative for preventing and treating denture stomatitis. The solubility of GE in various vehicles was determined. Subsequently, pseudo-ternary phase diagrams of the different ingredients, oil (LGO), surfactant (Tween 80), and co-surfactant (Propylene glycol) were selected to develop the SNEDDS. Then, SNEDDS containing GE and LGO (GL-SNEDDS) were prepared and characterized. The optimized liquid GL-SNEDDS was transformed into GL-mouthwash powder by absorbing onto mannitol and blending with a sweetener. Subsequently, various evaluations including drug recovery, moisture content, emulsification time, stability, anti- activity, and in vitro cytotoxicity were performed. The developed SNEDDS formulation improved GE and LGO solubility. The optimized GL-SNEDDS exhibited a small droplet size of 148.2 ± 2.1 nm with a polydispersity index of 0.11 ± 0.03 and a zeta potential of 2.14 ± 0.11 mV. In addition, the GL-mouthwash powder demonstrated a high drug recovery of >80% with a low moisture of <10% and exhibited greater physicochemical stability under accelerated conditions. The developed GL-mouthwash powder rapidly formed a stable nanoemulsion within 2 min after reconstitution. Interestingly, GL-mouthwash powder exhibited strong anti- activity with no toxicity to human fibroblast cells, which demonstrated superior biocompatibility relative to existing commercial products. These findings suggest that GL-mouthwash powder has potential as an alternative prevention and treatment of oral infection.
本研究旨在开发并表征一种包含高良姜提取物（GE）和柠檬草油（LGO）的自乳化药物递送系统（SNEDDS）的物理化学性质。然后，开发含有负载GE和LGO的SNEDDS的漱口粉（GL-漱口粉），作为预防和治疗义齿性口炎的一种有前景的替代方法。测定了GE在各种载体中的溶解度。随后，选择不同成分（油（LGO）、表面活性剂（吐温80）和助表面活性剂（丙二醇））的伪三元相图来开发SNEDDS。然后，制备并表征了含有GE和LGO的SNEDDS（GL-SNEDDS）。通过吸附到甘露醇上并与甜味剂混合，将优化后的液体GL-SNEDDS转化为GL-漱口粉。随后，进行了各种评估，包括药物回收率、水分含量、乳化时间、稳定性、抗菌活性和体外细胞毒性。所开发的SNEDDS制剂提高了GE和LGO的溶解度。优化后的GL-SNEDDS呈现出小液滴尺寸，为148.2±2.1nm，多分散指数为0.11±0.03，zeta电位为2.14±0.11mV。此外，GL-漱口粉显示出>80%的高药物回收率，水分含量低至<10%，并且在加速条件下表现出更高的物理化学稳定性。所开发的GL-漱口粉在重构后2分钟内迅速形成稳定的纳米乳液。有趣的是，GL-漱口粉表现出强大的抗菌活性，对人成纤维细胞无毒性，相对于现有商业产品显示出优异的生物相容性。这些发现表明，GL-漱口粉有潜力作为预防和治疗口腔感染的替代方法。
