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Background: Amphotericin B (AmB) is a commonly utilized antifungal agent, which is also recommended for the treatment of certain neglected tropical diseases, including leishmaniasis. However, its clinical application is constrained because of its poor oral bioavailability and adverse effects, prompting the investigation of alternative drug delivery systems. Polymeric nanoparticles (PNPs) have gained attention as a potential drug delivery vehicle, providing advantages such as sustained release and enhanced bioavailability, and could have potential as AmB carriers. However, concerns persist regarding nanomaterials’ toxicity, requiring more studies. Zebrafish (Danio rerio) embryos were used as a valuable model for toxicity testing, especially because of their genetic similarity to humans and standardized developmental assessments. Methods: In this study, we produced and characterized AmB loaded and non-loaded PNPs by nanoprecipitation, dynamic light scattering, transmission electron microscopy, atomic force microscopy and spectroscopy. Afterwards, we verified their toxicity through in vitro MTT assays in three cell lines (HEK293, HepG2, and J774 A1) and in vivo tests with zebrafish embryos. Results: In both trials, it was noted that nanoencapsulation of the drug led to increased toxicity when compared to non-encapsulated AmB, possibly indicating that they penetrated the embryo’s chorion. Nevertheless, it was demonstrated that the polymers used are safe and they are not the cause of toxicity, neither are the nanostructures per se. Conclusions: Therefore, it is believed that the objective of improving the bioavailability of AmB may have been achieved, and the observed toxicity was probably linked to AmB’s ability to destabilize cell membranes.

Introduction: Heparin is a drug that has anticoagulant activity, binding to antithrombin and accelerating the rate of inhibition of several proteases involved in the coagulation process. In the 2000s, the world market faced a troubled period regarding heparins after reports of allergic reactions and deaths caused by its use, requiring more rigorous quality control. Objective: The main goal of this work was to perform quality control of unfractionated sodium heparins of porcine origin commercialized in Brazil and heparin raw material on a dry basis, of both porcine and bovine origin, through potency assays. Method: Sixty-four samples of the final product (commercialized) were analyzed: 39 of brand A and 25 of brand B, and six samples of raw materials. Samples were assayed through anti-factor Xa and anti-factor IIa, according to United States Pharmacopeia (USP), and coagulation assay, described in the 5th edition of Brazilian Pharmacopeia (BP). Results: In the present study, 40 heparin samples were approved in all potency assays, while 24 samples were non-approved, 23 of brand A and one of brand B. All samples of porcine-origin raw materials were considered approved, while the three of bovine origin showed lower potency. Conclusions: Almost all non-approved samples presented potency above 110%, which may represent a bleeding risk for patients. Thus, it is necessary to monitor the quality control of heparins and assess the clinical condition of patients undergoing their use to identify and reduce risks and safeguard public health.