Formulation Development and Evaluation of Topical Film-Forming Lotion Containing Butenafine Hydrochloride

Abstract

Many agents are applied to the skin deliberately with beneficial outcomes. Conventional formulations intended for topical and dermatological administration of drugs such as creams, foams, gels and lotions are considered to reside for a relatively short period of time at the targeted site. The localized treatment of body tissues, diseases and wounds requires that the particular pharmaceutical component 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. The present work aims at designing and formulating a 'film- forming lotion' which on application will form a thin transparent film on the skin. Eudragit RL 100 and HPMC K4M was used to form a matrix film. The formulations were prepared using 32 full factorial design. They were tested for drying time, drug release, antifungal activity, skin irritation 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. All the formulations showed results within acceptable range for various tests. The optimized formulation showed drug release of 99.64% and antifungal activity in terms of efficacy as 98.72%. Such a formulation can be claimed to decrease duration of therapy, will be more accepted by the patients and be a breakthrough in treating fungal infections of the skin.