Surface-Engineered Nanomaterials: Environmental and Safety Considerations in Pharmaceutical and Medicinal Products

Abstract

Engineered nanomaterials have emerged as an important area in biomedical research due to their potential to improve human health. Many nanocomposites and new polymers are in the development phases, or have been introduced as preventive or therapeutic products and devices. However, some key safety issues related to acute and chronic use of these nanomaterials must be addressed prior to consideration for product development. Regulatory processes have evolved due to challenges in characterization of complex compositions and toxicological attributes of physical and chemical components. Composition and characteristic considerations include (i) nano, small size and low molecular weight materials that could penetrate the blood–brain and other physiological barriers causing neuro- and geno-toxicity and (ii) potential to generate free radicals that elicit oxidative stress and inflammation. Additionally, several other factors such as shape, surface area, dose, surface modifications and safety considerations should also be included in the design specification to avoid late-stage plausible product failure due to toxicology concerns. Environmental exposure to nanomaterials is another area of research that should address the impact of manufacturing and metabolic products generated by the application of nanomaterials in pharmaceuticals. This book chapter presents current knowledge on the biological fate, behavior and toxicity of different classes of nanomaterials and their impact on the environment.