Liposomal encapsulation masks genotoxicity of a chemotherapeutic agent in regulatory toxicology assessments

The role of a nanovector in influencing the stability and release of its payload is yet to be explored as a factor determining the genotoxicity of a nanotherapeutic complex. In this manuscript, we investigate for the first time, the mutagenicity and genotoxicity of a nanotherapeutic drug and compare it to its free form, in both bacterial and mammalian cell based assays recommended by the United States Food and Drug Administration and other regulatory agencies. Our findings reveal that encapsulation in the nanovector significantly masks the mutant frequency in the Ames/reverse mutation assay and appears non-genotoxic in the micronucleus assay.145