Evaluation of a 13-hexyl-berberine hydrochloride topical gel formulation.

Hui Lin Wei, Shuqi Wang, Feng Xu, Lan Fang Xu, Jia Run Zheng, Yun Chen

Institute of Dermatology, Peking Union Medical College, Chinese Academy of Medical Science, Nanjing, People's Republic of China. huilin.wei@gmail.com

Drug development and industrial pharmacy 2013 Apr

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13-hexyl-berberine hydrochloride (HB-13) is a derivative from berberine which finds widespread applications in the treatment of infectious pathogens including fungi, bacteria, parasites and viruses. As our continuing efforts for treatment of herpes simplex virus (HSV), we studied the topical delivery and safety of HB-13 in a gel formulation (0.5%) in a pig model. Our studies demonstrated the maximal HB-13 concentration was 2.51 µg/mL, which was more than the half maximal inhibitory concentration (IC50) as we previously reported. In addition, there was no sign of irritation or histological aberrance for stripped skin continuously applied with 0.5% HB-13 gel for 21 days. In conclusion, 0.5% HB-13 gel can achieve effective anti-HSV concentration in the dermis and it is safe to use.

Citation

Hui Lin Wei, Shuqi Wang, Feng Xu, Lan Fang Xu, Jia Run Zheng, Yun Chen. Evaluation of a 13-hexyl-berberine hydrochloride topical gel formulation. Drug development and industrial pharmacy. 2013 Apr;39(4):534-9