A STATISTICAL APPROACH TO DEVELOPMENT OF SUSTAINED RELEASE PRONIOSOMAL MICONAZOLE NITRATE GEL

Miconazole nitrate is a broad-spectrum antifungal agent, and it is used for the treatment of superficial fungal infections. It has low skin permeability. Therefore, the aim of this study was to prepare proniosomal 2% miconazole nitrate sustained release to a treat deep-seated fungal infections. The different batches of proniosomal 2% miconazole nitrate gel were prepared by the conservation phase separation method using different non-ionic surfactants and Cholesterol. Preliminary trial batches were formulated and evaluated for different evaluation parameters like pH, viscosity, % entrapment efficiency, % drug content, and in-vitro drug release study. A 3² full factorial design was used to check the effect of Span 60 (X₁) and Cholesterol (X₁) on % entrapment efficiency (EE) and % drug release at 20 h (Q₂₀). Multiple linear regression analysis, ANOVA, and graphical representation of the influence factor by 3D response surface plots were performed using Design Expert 9. Checkpoint batch was prepared to validate the evolved model. Optimized batch was found to be stable, and it showed release 94.76% in 24 h. It followed the non-fickian diffusion and showed flux 289 μg/cm²/h in the ex-vivo study. SEM revealed that the noisome formed were spherical in shape. Therefore, proniosomal 2% miconazole nitrate gel has the ability to penetrate the skin and give the effect for a long time.