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Thermoreversible Gel-Loaded Amphotericin B for the Treatment of Dermal and Vaginal Candidiasis

1
Department of Pharmacy and Pharmaceutical Technology and Physical Chemistry, School of Pharmacy and Food Sciences, University of Barcelona, 08028 Barcelona, Spain
2
Institute de Nanoscience and Nanotechnology (IN2UB), University of Barcelona, 08028 Barcelona, Spain
3
Departamento de Química y Ciencias Exactas, Universidad Técnica Particular de Loja, Loja 1101608, Ecuador
4
Department of Biology, Healthcare and the Environment, School of Pharmacy and Food Sciences, University of Barcelona, 08028 Barcelona, Spain
5
Department of Biochemistry and Physiology, Faculty of Pharmacy and Food Sciences, University of Barcelona, 08028 Barcelona, Spain
6
Institut de Recerca en Nutrició i Seguretat Alimentària (INSA), Universitat de Barcelona, 08921 Barcelona, Spain
7
Department of Pharmacy and Pharmaceutical Technology, School of Pharmacy, University of Granada, 18071 Granada, Spain
*
Author to whom correspondence should be addressed.
Pharmaceutics 2019, 11(7), 312; https://doi.org/10.3390/pharmaceutics11070312
Received: 22 May 2019 / Revised: 30 June 2019 / Accepted: 1 July 2019 / Published: 3 July 2019
(This article belongs to the Special Issue Antifungal and Antiparasitic Drug Delivery)
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Abstract

The present study was designed to develop a thermoreversible gel of Pluronic (P407) loaded amphotericin B (AmB-gel) for the dermal and vaginal treatment of candidiasis. P407 was used as a copolymer to exploit potential advantages related to increasing drug concentration in the tissue layer in order to provide a local effect. Parameters including internal structure, swelling, porosity, and short-term stability were determined. In addition, drug release profile and ex vivo skin and vaginal permeation studies were carried out. Antifungal efficacy was evaluated against strains of Candida spp. and atomic force microscopy (AFM) supported the results. The tolerance of AmB-gel was studied by evaluating biomechanical properties of skin and determining the irritation level in scarified rabbit skin supported by histological analysis. Results confirmed the development of a thermoreversible AmB-gel with high porosity exhibiting Newtonian behavior at 4 °C and pseudoplasticity at 32 °C as well as optimal stability for at least 90 days. The Amb-gel provided a sustained drug release following a Boltzmann sigmoidal model. Non permeation was observed in skin and vaginal mucosa, showing a high retained amount of AmB of 960.0 and 737.3 µg/g/cm2, respectively. In vitro antifungal efficacy showed that AmB-gel was more effective than Free-AmB in inhibiting strains of Candida spp. and these results were corroborated by AFM. Finally, tolerance studies showed that its application did not induce skin irritation nor alter its biophysical properties. Together, these results confirmed that AmB-gel could be proposed as a promising candidate for the clinical status in the treatment of skin and vaginal candidiasis. View Full-Text
Keywords: thermoreversible gel; poloxamer 407; candidiasis; amphotericin B; skin and vaginal mucosa thermoreversible gel; poloxamer 407; candidiasis; amphotericin B; skin and vaginal mucosa
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Sosa, L.; Calpena, A.C.; Silva-Abreu, M.; Espinoza, L.C.; Rincón, M.; Bozal, N.; Domenech, O.; Rodríguez-Lagunas, M.J.; Clares, B. Thermoreversible Gel-Loaded Amphotericin B for the Treatment of Dermal and Vaginal Candidiasis. Pharmaceutics 2019, 11, 312.

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