Development and Optimization of a Luliconazole Film-Forming Topical Spray Using a Quality by Design Approach

Abstract

Luliconazole is a topical antifungal agent used in the management of superficial fungal infections. Film-forming topical sprays may provide convenient application and facilitate the formation of a uniform drug-containing film at the site of administration. The present study aimed to develop and optimize a Luliconazole film-forming spray using a Quality by Design (QbD) approach. A (2^3) full factorial design was employed to investigate the effects of Hydroxypropyl Cellulose (HPC), Eudragit® RS100, and PEG 400 on critical formulation responses, with drying time and viscosity selected as dependent variables. Eight formulations (F1–F8) were prepared by varying the concentrations of the selected formulation components and evaluated for appearance, film formation, pH, viscosity, drying time, spray angle, film thickness, folding endurance, stickiness, washability, leak test, drug content, and in vitro drug diffusion. Statistical analysis and response-surface methodology were used for formulation optimization. The prepared formulations were clear and homogeneous and exhibited acceptable film-forming properties. Drying time ranged from 3.8 to 8.2 min, while viscosity ranged from 162 to 438 cP. The formulation variables significantly influenced the investigated responses. Formulation F8, containing 1% w/v HPC, 4% w/v Eudragit® RS100, and 5% v/v PEG 400, was selected as the optimized formulation. F8 exhibited a drying time of 5.1 min, viscosity of 304 cP, and spray angle of 83.6°. It produced a uniform, transparent, non-sticky, and adherent film, with drug content of 99.2 ± 0.8%. The QbD approach enabled systematic optimization of the Luliconazole film-forming spray and identified F8 as a promising formulation with desirable spray and film-forming characteristics for topical drug delivery.