Drug products containing nanomaterials: New FDA guidelines

Nanomaterials have revolutionized biotherapeutics, functioning in a variety of roles ranging from active ingredients to drug carriers. Although no regulatory definition of nano-based drugs (drug products containing nanomaterials) has ever been established, these drugs have two distinct characteristics:1

Owing to their smaller size, they can move much more freely within the body and penetrate the tissue system efficiently, thus making them excellent drug-delivery agents. For example, several nanoparticle lipid-system-containing drugs have been used in the targeted destruction of cancer cells. By preventing gastrointestinal degradation and facilitating a prolonged release of the active ingredient, nanostructures can significantly enhance the bioavailability of drugs.2