Purpose

This study aimed to prepare a suitable formulation and perform in vitro characterization studies for oral use by exploiting the synergistic effect of alpha-lipoic acid (ALA) and cyanocobalamin (Vit B₁₂) for the treatment and prophylaxis of various diseases such as diabetic neuropathy, peripheral neuropathy, and neurological disorders.

Methods

Nanoemulsions were prepared using different oils (castor oil (CO) and sunflower oil (SO)) and agitation methods (magnetic stirring and ultraturrax). The effects of experimental parameters on droplet size, polydispersity index, zeta potential, encapsulation efficiency, and release rate properties of nanoemulsions were investigated. The physical and chemical stability of formulations at various temperatures (30°C, 50°C, and 70°C) and pH values (1.2, 4.5, 6.8, and 7.4) were also evaluated.

Results

An HPLC method, enabling the simultaneous determination of ALA and Vit B₁₂, has been successfully developed with a correlation coefficient value of 0.9999 for both analytes. The best results were obtained by CO and magnetic stirring in terms of colloidal properties for either plain (P-C-NE) or ALA-Vit B₁₂ co-loaded (C-NE) nanoemulsions. The C-NE had better stability under different conditions, higher encapsulation efficiency (ALA-93.80%, Vit B₁₂-110.65%), and release percentage.

Conclusion

As a result, this study demonstrated that nanoemulsions containing ALA and Vit B₁₂ can be successfully produced and are stable at different temperatures and pH values.

Graphical abstract

中文翻译：

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硫辛酸和氰钴胺共载纳米乳液：稳定性的发展，表征和评估。

目的

这项研究的目的是通过利用α-硫辛酸（ALA）和氰钴胺素（Vit B ₁₂）的协同作用来治疗和预防糖尿病性神经病等各种疾病，从而制备合适的制剂并进行口服表征研究周围神经病和神经系统疾病。

方法

使用不同的油（蓖麻油（CO）和葵花籽油（SO））和搅拌方法（磁力搅拌和Ultraturrax）制备纳米乳液。研究了实验参数对纳米乳液液滴尺寸，多分散指数，ζ电势，包封效率和释放速率特性的影响。还评估了制剂在各种温度（30°C，50°C和70°C）和pH值（1.2、4.5、6.8和7.4）下的物理和化学稳定性。

结果

已经成功开发了一种能够同时测定ALA和Vit B ₁₂的HPLC方法，两种分析物的相关系数值为0.9999。就普通（PC-NE）或ALA-Vit B ₁₂共载（C-NE）纳米乳液的胶体性质而言，通过CO和磁力搅拌可获得最佳结果。C-NE在不同条件下具有更好的稳定性，更高的包封效率（ALA-93.80％，Vit B ₁₂ -110.65％）和释放百分比。

结论

结果，该研究表明，可以成功地生产出含有ALA和Vit B _12的纳米乳液，并且它们在不同的温度和pH值下都稳定。

图形概要