RESUMO
The objective of the present study was to design and develop topical pharmaceutically acceptable nonionic surfactant systems for poorly water-soluble triazole antifungal agents such as Fluconazole [flu.] and Terconazole [ter.]. Several systems have been developed using selected ingredients of oils with penetration enhancing properties and antimicrobial activity, surfactants and co-surfactants. All ingredients were able to form clear microemulsione that differ in their domain area according to the types and ratios of the ingredients used. The developed formulae were evaluated with respect to their physic-chemical characteristics like electrical-conductivity, particle size, rheological behavior and apparent viscosity as well as in vitro drug release in acetate buffer pH 5.5. Accelerated physical stability studies were achieved for all systems to confirm the inherent high stability characteristics of the microemulsion. Microbiological efficacy of medicated and nonmedicated formulae have been studied and compared with each other and with some of the available commercial products against Aspergillus niger, Candida albicans, and Trichophyton mentagrophytes. Finally, the chosen formulae were conducted to [21-day cumulative irritancy patch] irritation test followed by a clinical study. The clinical results revealed that most of patients were improved affirming the results of microbiological activity especially against dermatophytic infections. Variations in curative or improvement time were related to the difference in case severity, adherence to the treatment, prevention tips that were dispensed to patients and some other individual variations e.g. skin type, life style, age, gender, etc