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- W2316656192 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." @default.
- W2316656192 created "2016-06-24" @default.
- W2316656192 creator A5055853083 @default.
- W2316656192 date "2014-01-01" @default.
- W2316656192 modified "2023-09-25" @default.
- W2316656192 title "Topical Delivery of Lipid Based Amphotericin B Gel in the Treatment of Fungal Infection: A Clinical Efficacy, Safety and Tolerability Study in Patients" @default.
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- W2316656192 doi "https://doi.org/10.4172/2155-9554.1000248" @default.
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