Evaluación preliminar de la estabilidad y eficacia de nuevas formulaciones tópicas bioadhesivas de Anfotericina-B con potencial aplicación en el tratamiento de Leishmaniasis cutánea

Congreso; 6TA REUNIÓN INTERNACIONAL DE CIENCIAS FARMACÉUTICAS (RICIFA 2020+1); 2021

Cutaneous leishmaniasis (CL) is an endemic parasitic-disease in Latinoamérica. Currently, high cost, toxicity and adverse events incidence of available treatments contribute to high morbi-mortality. Systemic amphotericin-B (AmB) is recommended in resistant infections, but poor solubility, permeability and stability are conditioning factors for its formulation. This work is focused on formulation of new topical dosage forms containing AmB, based on ternary interpolyelectrolyte complexes (IPEC) with hyaluronic acid and chitosan. From IPEC, 3 formulations were prepared containing AmB (0.1%), 1 hydrogel and 2 spray forms, using arginine or lecithin as absorption enhancer or humectant. The quality attributes of formulation were assayed by dynamic/oscilatory rheometry, texturometry, extensibility/sprayability and HPLC/UV determinations. All formulations presented appropriate physico-mecanical and adhesive behaviours for facilitating the application, coverage and permanence on the skin. The IPEC and formulations showed increased stability compared to AmB solution and their antifungal activity (MIC50/MFC) against C. albicans (SC5314), were not modified for IPEC nor by the passage of time. Evaluations of topical lesions on murine model showed similar efficacy of formulation with respect to systemic reference. Lecithin contain? formulation showed loss of effectiveness.These results suggest bioadhesive topical modified-release IPEC-based formulations of AmB are interesting, efficient and accessible alternatives for optimizing CL treatment.