Perspectives on Quality Attributes of Drug Products Containing Nanomaterials

• Published in: Pharmaceutical technology Europe pp. S12 - S14
• Main Authors: Hickey, Anthony, Akala, Emmanuel, Block, Lawrence, Hammond, John, Hussain, Munir, Kleintop, Brent, Lewen, Nancy, Liang, June, Mitchell, Jolyon, Maurer, Norbert, Scoggins, Myke, Shelbourn, Timothy, Tice, Thomas, Tyner, Katherine, Welfare, Eloise, Zaidi, Kahkashan
• Format: Journal Article
• Language: English
• Published: Monmouth Junction MultiMedia Healthcare Inc 01.09.2019
• Subjects: Bioavailability; Drug dosages; Microscopy; Nanocrystals; Nanomaterials; Nanoparticles; Nanotechnology; Oral administration; Particle size; Quality; United States > US
• ISSN: 1753-7967

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 for micro-aggregated nanoparticles and < 1601 > nebulized particles or low-pressure impactor for nanoparticle aerosols (23) * Composition and structure using atomic absorption spectroscopy and photoncorrelation spectroscopy * Dissolution and in-vitro release using microdialysis (24), fibre 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. Anthony Hickey, Emmanuel Akala, Lawrence Block, John Hammond, Munir Hussain, Brent Kleintop, Nancy Lewen, June Liang, Jolyon Mitchell, Norbert Maurer, Myke Scoggins, Timothy Shelbourn,Thomas Tice, Katherine Tyner, Eloise Welfare, all members of the Joint Subcommittee of the United States Pharmacopeia Expert Committees on Dosage Forms, Chemical Analysis, Physical Analysis, and Excipients; and Kahkashan Zaidi, United States Pharmacopeia·, kxz@usp.org Every drug product requires the assessment of quality parameters to grant safety and efficacy to be released for human and veterinary use.