Fungal Infections: Effect of Eudragit RL-100 Based Miconazole Film Forming Spray

ABSTRACT

Background: Miconazole nitrate, a BCS class II drug which is used for treatment of fungal infections. To minimize the disadvantages of sticky creams and ointments and their tendency to rub off, an intelligent dosage regimen needs to be designed as a film-forming spray formulation. The aim of this investigation was to develop a film-forming spray formulation containing 0.5% Miconazole nitrate for the treatment of fungal infections on the skin.

Materials and Methods: The Miconazole nitrate film-forming spray formulation was prepared using different concentrations of Eudragit RL-100, Ethylcellulose, Camphor and Menthol crystals (Eutectic mixture), Polyethene glycol 400 and Ethanol by simple solvent dissolving method using a statistical tool, 23 full factorial design to optimize the film forming spray formulation. The film-forming spray underwent thorough testing to evaluate its formulation characteristics, including pH, viscosity, evaporation time, density, drug release and container-related factors such as spray angle, spray diameter and amount of spray solutions released per actuation at valve assembly. To carry out an antifungal activity test on an optimized spray formulation and compare it with a commercially available cream.

Results and Discussion: From the study, the ethyl cellulose concentration has a greater influence on the viscosity and density, 45 cps and 0.8472 g/mL of the spray formulation respectively. Eudragit RL-100 and the eutectic mixture have a higher impact on the drug release 92.44% at 8 hr in pH 6.8 phosphate buffer.

Conclusion: The topical treatment of fungal infections proved to be suitable for the Miconazole nitrate film-forming spray formulation. Longer, continuous medication administration is facilitated by the skin’s longer retention period. The medication exhibits good antifungal effectiveness in preventing fungal infections, according to antifungal investigations. The Miconazole nitrate film-forming spray is a considerably better alternative to current dosage forms for treating topical fungal infections, as evidenced by its good stability, simplicity of administration and action.

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Materials

A gift sample of Miconazole nitrate was obtained from SKN Organics (P) Ltd., located in Puducherry. Eudragit RL-100 (Otto Chemie Pvt. Ltd., Mumbai), Ethyl Cellulose (Loba Chemie Pvt. Ltd., Mumbai), Camphor (Oxford Lab Fine Chem. LLP., Maharashtra), Menthol crystal (Loba Chemie Pvt. Ltd., Mumbai), PEG 400 (SD fine chem. Ltd., Coimbatore), Ethanol (Yarrow Chem products, Mumbai) were used.

Panneerselvam K, Somaskanthan S. Fungal Infections: Effect of Eudragit Rl-100 Based Miconazole Film Forming Spray. Int. J. Pharm., Investigation. 2024;14(3):928-34.

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