Topical Delivery of Lipid Based Amphotericin B Gel in the Treatment of Fungal Infection: A Clinical Efficacy, Safety and Tolerability Study in Patients
- *Corresponding Author:
- Imran Ahmad
Jina Pharmaceuticals, Inc. 28100 Ashley Circle
Suite 103, Libertyville, IL, USA
Tel: 847 557 0771
Fax: 847 557 0770
E-mail: [email protected]
Received date: August 29, 2014; Accepted date: November 22, 2014; Published date: November 29, 2014
Citation: Sheikh S, Ahmad A, Ali SM, Paithankar M, Raval RC, et al. (2014) Topical Delivery of Lipid Based Amphotericin B Gel in the Treatment of Fungal Infection: A Clinical Efficacy, Safety and Tolerability Study in Patients. J Clin Exp Dermatol Res 5:248. doi:10.4172/2155-9554.1000248
Copyright: © 2014 Sheikh S, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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.