Safety assessment of a new nanoemulsion-based drug-delivery system reveals unexpected drug-free anticoagulant activity.

Aim: A preclinical safety assessment of a novel nanoemulsion drug-delivery system, initially developed to improve the posology of efavirenz (EFV), was conducted with a specific focus on possible immunological and hematological complications. Materials & methods: Assessment of common acute toxicities, such as complement activation and cytokine secretion, was performed using validated assays known to have good correlation with in vivo end points. Results & conclusion: Compared with a standard aqueous solution of EFV, the EFV nanoemulsion showed no significant effect on immune cell function or phenotype. Prolongation of activated partial thromboplastin time was observed for EFV-loaded nanoemulsions (88% at 4 μg/ml) as well as unloaded nanoemulsions (52%) highlighting the potential for drug-free anticoagulant activity and warranting further investigation of the mechanism and utility of these materials.