Formulation, Characterization and Toxicity Assessment of Ginkgo Biloba Extract Solid Lipid Nanoparticle in female mice

Abstract

Aims and Objectives: We aimed in present study to provide solid-lipid nanoparticle (SLN) of GBE and evaluate its oral safety in the light of recent discoveries on strong inhibitory effects of Ginkgo Biloba Leaf Extract (GBE) against Covid 19 and Influenza virus .Materials and Methods: Morphology and particle sizes of nanoparticles were analyzed by Scanning Electron Microscopy (SEM), Atomic Force Microscopy (AFM) and Dynamic Light Scattering (DLS) methods. In the next step, the release profile of 85% loaded SLNs was determined by dialysis membrane method. Acute and repeated dose oral toxicity tests were performed on selected freeze-dried formulation with appropriate stability in female mice according to OECD 425 and OECD 407 guidelines .Results: The spherical GBE-SLN released GBE during the first 72 hrs. In acute oral test, doses up to 2000 mg/kg didn’t cause mortality or any sign of toxicity .Repeated dose oral toxicity study on three dose levels (0.5, 5, 50 mg/kg/ day), didn’t show any abnormal change due to clinical, biochemical and necropsy evaluations but hematological assessment showed abnormal coagulation in accordance with some abnormal changes in the liver, kidney, heart, lungs and ovaries of high dose (50mg/kg) group of animals. Conclusion: Repeated dose oral administration of GBE-SLN in doses up to 5 mg/kg/day was considered as safe dose level. Later studies are mandatory for evaluating the preventive and therapeutic effects of present GBE-SLN against Covid 19 in appropriate in vitro and in vivo models.