Perspectives on Quality Attributes of Drug Products Containing Nanomaterials"

Abstract

Over a period of 10 years, spanning the turn of the Millennium, products for cancer (doxorubicin and paclitaxel), anaemia (sodium ferric gluconate complex), macular degeneration (pegaptanib sodium), tear production (cyclosporine), aspergillosis (amphotericin B), acromegaly (lanreotide acetate), and hypercholesterolaemia (fenofibrate) as liposomes, inorganic, and polymeric (natural and synthetic), nanotubes, nanocrystal emulsions, and micelles (19) were prepared. A comprehensive approach to the measurement of physicochemical characteristics includes the following: * Aerodynamic particle size distribution using USP <601> for micro-aggregated nanoparticles and <1601> nebulized particles or low-pressure impactor for nanoparticle aerosols (23) * Composition and structure using atomic absorption spectroscopy and photon-correlation spectroscopy * Dissolution and in-vitro release using microdialysis (24), fiber optic probe (25), infrared (26) and Raman (27) spectroscopy * Encapsulation efficiency * Particle size using scanning and transmission electron microscopy (SEM and TEM) and atomic force microscopy (AFM) * Particle distribution using photon correlation spectroscopy, small angle X-ray and neutron scattering (SAXS and SANS); * Purity, shape using SEM, TEM, AFM, SAXS and SANS, and solubility * Surface area using gas adsorption, surface properties using X-ray photoelectron spectroscopy, secondary ion mass spectroscopy, zeta potential, and freeze fracture SEM * Physical stability. [...]dissolution testing may be a tool that can be used for evaluation. The most frequently measured characteristic-particle size distribution-and the DLS and high-resolution imaging techniques employed will be the initial focus of the USP in preparing general chapters to address these topics.