Abstract
Objectives: A novel topical formulation of lipid based amphotericin B (0.1% amphotericin B Gel) was developed to assess the safety, tolerability and efficacy in adult patients with cutaneous and/or mucocutaneous fungal infection. Methods: Amphotericin B gel was formulated using lipids. In vitro release assay of amphotericin B was measured using paddle apparatus maintained at 37.0° ± 0.5°C. The stability studies of amphotericin B gel were carried out at 2-8°C, 25°C and 40°C. To test the effect of the drug in clinical setting, 100 patients with recurrent case after failure to standard therapy for cutaneous and/or mucocutaneous fungal infection were treated with amphotericin B Gel. The amphotericin B Gel was applied on the affected area twice daily for 14 days in patients with cutaneous fungal infection and for 7 days in patients of mucocutaneous fungal infection. Response to the amphotericin B Gel treatment was monitored in the patients for up to 14 days and 28 days for mucocutaneous and cutaneous infection respectively. Results: Based on the stability studies, the recommended shelf life of amphotericin B gel is 24 months at 25°C. In vitro studies showed the release of ~90% amphotericin B within two hours and complete release within four hours. A total of 83 patients were assessed for cutaneous fungal infection where 39 patients were cured, 9 patients showed marked improvement, 26 patients showed moderate improvement and 9 patients showed failure after the treatment. For mucocutaneous fungal infection, 100% patients were cured at the end of the treatment. No serious adverse events were reported in patients during the study. Conclusion: Lipid based amphotericin B gel in patients with cutaneous and mucocutaneous fungal infections was found to be safe, tolerable and efficacious.
Highlights
Among the fungal infections, the cutaneous is the most prominent type occurring in human where fungi colonize on dead tissue of the stratum corneum is called dermatophyte
Topical drugs are applied to the surface of the skin in the form of cream, lotion, or spray that can penetrate into the skin and prevent them from spreading of infection to the tissues
The present study demonstrates that lipid based Amphotericin B gel is highly effective and safe to treat cutaneous and mucocutaneous fungal infections
Summary
The cutaneous is the most prominent type occurring in human where fungi colonize on dead tissue of the stratum corneum is called dermatophyte. These types of fungi do not produce deep cutaneous or systemic infections. Several treatment options are available for cutaneous fungal infection [2]. A number of drugs such as miconazole, clotrimazole, and ketoconazole have been used for the treatment of fungal and yeast skin infections. Patients look for cure in shortest possible time as the infection can appear on any expose part of the skin that could cause irritation and discomfort in the normal routine. Patients tend to look for cost effective ways due the availability of several options
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