Quality By Design Driven, Development And Assessment Of A Nanoemulsion Based Gel Comprising Of Fenticonazole Nitrate And Clary Sage Oil Loaded For The Effective Treatment Of Fungal Infections

Abstract

Fenticonazole nitrate is a selective azole, antifungal agent that is only weakly soluble in water (about 0.000304 mg/ml), and it’s useful when given in the right amount to treat fungal infections. This project attempted to create a nanoemulsion of Fenticonazole nitrate using clary sage oil, which is known for its antifungal properties, to help fight fungal infections. We optimized the nanoemulsion using a D-optimal design and then incorporated the same amount into a gel made with Carbopol 934P. The best nanoemulsion had about 36.44% Smix, 9.3% oil, and 54.24% water. It had a small globule size of 140 nm and a polydispersity index of 0.316. The zeta potential was measured at -14.6 mV. Its viscosity was around 36 cPs, while the gel made from it was much thicker at 2950 cPs. The pH of the nanoemulsion was 6.73. All of the nanoemulsions were oil-in-water type, which we confirmed with a conductivity measurement of 69.8 (200 µs). When tested outside the body, the nanoemulsion gel released about 69.48% of the drug after 5 hours, and in laboratory conditions, the release went as high as 89.21%. We found that combining chamomile oil with the nanoemulsion gel containing Fenticonazole nitrate boosted its antifungal activity, as shown by the larger inhibition zones. When comparing to commercial products, the 0.4% nanoemulsion based gel (NEBG) showed a bigger zone of inhibition than other formulations, even with a relatively moderate dose of Fenticonazole nitrate, indicating it's effectiveness.