ERIK TEDESCO, FEDERICO BENETTI*
ECSIN-European Center for the Sustainable Impact of Nanotechnology, ECAMRICERT SRL, Rovigo, Italy

Abstract

Nanomedicine opens new frontiers for treating, curing and diagnosing diseases due to the unique physico-chemical properties of nanomaterials. Nano-based drug delivery systems are one of main applications of nanomedicine. To develop promising nano-based drug delivery systems, both efficacy and safety should be carefully evaluated. However, at present, a rational and solid approach in response to these needs has not been devised. In the present work we present a novel testing strategy, based on in vitro cell models and approaches, aimed to evaluate the safety of orally administered nanocarriers, emphasizing the importance of harmonized and validated standard operating procedures in a safe-by-design context

INTRODUCTION

Nanomedicine, referred as medical application of nanotechnology, aims to exploit nanomaterial peculiar properties to improve human health. Many “soft”, organic (liposomes, dendrimers, micelles, etc.) nanostructures, suited for therapeutic delivery application (i.e. Abraxane and Doxil) (1-5) and “hard”, inorganic (i.e. Endorem) nanostructure (6,7), are already commercially available. Due to its low costs and good patient compliance (8), in recent years many efforts have been made to improve drug delivery through the oral administration route. Conversely from other administration routes (dermic, inhalatory, etc.), orally administered drugs are exposed to extremely different biological and chemical conditions that could mine their stability. Nano-based drug delivery systems able to withstand the harsh gastrointestinal conditions and favoring a controlled release and targeting of drugs could be used to overcome these problems. However, the potential health risks associated to the administration of these carriers need to be carefully evaluated (9).

Nano-based oral formulation ability to resist the harsh conditions o ...