Abstract

FORMULATION, DEVELOPMENT AND EVALUATION OF FILM-FORMING GEL FOR SUSTAINED RELEASE DELIVERY OF LULICONAZOLE

Suvarna Bhausaheb Kale* and Rishikesh Shankar Bachhav

ABSTRACT

Objective: The present study was to prepare a topical film-forming gel for sustained release delivery of luliconazole. Luliconazole is an imidazole derivative and used for the treatment of local and systemic fungal infection such as, tinea pedis, tinea cruris or tinea corporis, using a patient-friendly drug delivery approach. Commercially luliconazole topical film-forming gel preparation are not available in the market. The localized treatment of diseases of body tissues requires that the pharmaceutical active be maintained at the site of treatment for an effective period of time. Sweat, clothing, movements and getting washed away easily on contact with water are some of the problems that have limited the effectiveness and residence time of conventional topical formulations for treatment of fungal infections of skin. This necessitates longer treatment duration. Hence, a composition that adheres to skin surface afflicted and provides localized delivery of an antifungal agent is needed. Methods: The present work aims at designing a dosage form of luliconazole referred to as a „film-forming gel‟ which on application forms a thin, transparent film on skin surface. Eudragit RL(PO) as a film forming polymer, HPMC (hydroxypropylmethyl cellulose) as a gel forming agent and were used in combination to provide a matrix film that would permit the release of the antifungal agent requires to be present at the site of infection for longer period of time. The formulations were prepared using 32 full factorial design. They were tested for drying time, drug release, antifungal activity, and stability studies. The gel was characterised for pH, viscosity, drug content, effective dosage volume and mechanical properties of the film formed after application; bioadhesion and water vapour permeability were also tested. Results: All the formulations showed results within acceptable range for various tests. The optimized formulation showed drug release of 98.74% and antifungal activity in terms of efficacy as 98.44%. Conclusion: It was concluded that formulation F5 was the best formulation among this formulation. Hence formulation F5 should be further developed for scale-up to industrial production.

Keywords: Luliconazole (LCZ); Fungal Skin Infections; Film-Forming Gel (FFG); Eudragit RS PO; Hyroxylpropryl Methyl Cellulose (HPMC).