Desenvolvimento e avaliação da biossegurança de nanocápsulas de atorvastatina co-encapsuladas com óleo de gengibre ou semente de uva

Abstract

This study aimed to develop nanocapsules co-encapsulated with Atorvastatin (ATV) and ginger oil (NCAtG) or grape seed (NCAtU). The proposed formulations showed an average particle size between 200 and 300 nm. They are stable and with adequate dispersion when evaluated by laser diffractometry (DL) and photon correlation spectroscopy (PCS) techniques. An analytical methodology for determining ATV in nanocapsules has been properly validated by HPLC. We found that the ATV encapsulation efficiency was 97% for both formulations. The release profiles of ATV in dialysis medium were sustained and 82% at the end of 8h for NCAtG and NCAtU. As or biological safety, NCAtG and NCAtU were added to blood samples at concentrations of 10, 50 and 100 μg / mL. NCAtG caused a significant increase in free hemoglobin at the highest concentration and NCAtU at concentrations of 50 and 100 μg / mL. In addition, NCAtU generated greater erythrocyte LDH release when compared to NCAtG. On the other hand, there was no change in the parameters of the blood coagulation cascade either by the extrinsic (TP) or by the intrinsic (TTP) route. No changes in DNA integrity or cytotoxicity were observed in 3T3 cell lines. In addition, mortality, size and body area or litter size parameters were not changed when applied to the C. elegans experimental biological model. Finally, the formulations demonstrated significant effects on the reduction of lipid levels of nematodes with dyslipidemia. This effect was not dose dependent. Higher doses of NCAtU do not improve the effect on dyslipidemia and can lead to complications regarding biocompatibility.