ABSTRACT

Nanotechnology comprises a multidisciplinary science dedicated to create, explore and manipulate a broad array of materials and/or systems in a nanometer size scale, i.e. with at least one dimension ranging from approximately 1 to 1,000 nm. The US Food and Drug Administration considers nanotechnology products as materials, ingredients and other substances, including drugs, biologicals, medical devices, cosmetics, foods, dietary supplements, which are engineered with at least one dimension in the nanoscale, usually presenting physicochemical properties and/or biological effects attributable to its dimensions. Biopharmaceuticals such as peptides, therapeutic proteins, enzymes, monoclonal antibodies, nucleic acids, antibody–drug conjugates, hormones and vaccines have structural complexity and are susceptible to degradation, which brings additional challenges for the development of pharmaceutical formulations. Since the late 1980s, the enhanced permeability and retention effect is described as responsible for the accumulation of nanostructures and macromolecules at much higher concentrations in tumour tissues than in healthy tissues and organs.