Gallic acid loaded self-nano emulsifying hydrogel-based drug delivery system against onychomycosis.

Mohammad Sameer Khan, Mahak Fatima, Shadma Wahab, Mohammad Khalid, Prashant Kesharwani
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Abstract

Aim: To developed and investigate gallic acid (GA) loaded self-nanoemulsifying drug delivery systems (SNEDDS) for treating onychomycosis via transungual route. Materials & methods: The SNEDDS were prepared by direct dispersion technique and were evaluated for characteristics parameters using Fourier transform infrared, differential scanning calorimetry, confocal microscopy, transmission electron microscopy and zeta sizer. Furthermore, the safety of prepared formulation was evaluated via Hen's egg test-chorioallantoic membrane study and stability was confirmed using different parameters. Also, its effectiveness was evaluated against fungal strain Trichophyton mentagrophytes. Results: The SNEDDS displayed a particle size of 199.8 ± 4.21 nm and a zeta potential; of -22.75 ± 2.09 mV. Drug release study illustrated a sustained release pattern with a release of 70.34 ± 0.20% over a period of 24 h. The penetration across the nail plate was found to be 1.59 ± 0.002 µg/mg and 0.97 ± 0.001 µg/mg for GA loaded SNEDDS and GA solution respectively. An irritation score of 0.52 ± 0.005 and 3.84 ± 0.001 was reported for GA loaded SNEDDS hydrogel and GA solution, indicating a decrease in the drug's irritation potential from slightly irritating to non irritating due to its entrapment within the SNEDDS. Conclusion: GA loaded SNEDDS has potential to address limitations of conventional treatments, enhancing the drug's efficacy and reducing the likelihood of resistance in the treatment of Onychomycosis.

以没食子酸为载体的自纳米乳化水凝胶给药系统防治甲癣。
目的:开发并研究通过经皮途径治疗甲癣的没食子酸(GA)负载型自纳米乳化给药系统(SNEDDS)。材料与方法:采用直接分散技术制备了自纳米乳化给药系统,并使用傅立叶变换红外光谱、差示扫描量热仪、共聚焦显微镜、透射电子显微镜和 zeta 分析仪对其特性参数进行了评估。此外,还通过母鸡卵试验-绒毛膜研究评估了制备配方的安全性,并使用不同参数确认了其稳定性。此外,还评估了该制剂对真菌毛癣菌的有效性。结果SNEDDS 的粒径为 199.8 ± 4.21 nm,zeta 电位为 -22.75 ± 2.09 mV。载药 SNEDDS 和 GA 溶液在甲板上的渗透率分别为 1.59 ± 0.002 µg/mg 和 0.97 ± 0.001 µg/mg。据报告,GA负载SNEDDS水凝胶和GA溶液的刺激性评分分别为0.52 ± 0.005和3.84 ± 0.001,这表明由于药物被SNEDDS包裹,药物的刺激性从轻微刺激性降低到无刺激性。结论负载 GA 的 SNEDDS 有可能解决传统治疗方法的局限性,提高药物疗效,降低治疗甲癣的抗药性可能性。
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