Melissa A Graewert, Christoph Wilhelmy, Tijana Bacic, Jens Schumacher, Clement Blanchet, Florian Meier, Roland Drexel, Roland Welz, Bastian Kolb, Kim Bartels, Thomas Nawroth, Thorsten Klein, Dmitri Svergun, Peter Langguth, Heinrich Haas
We present a generically applicable approach to determine an extensive set of size-dependent critical quality attributes inside nanoparticulate pharmaceutical products. By coupling asymmetrical-flow field-flow fractionation (AF4) measurements directly in-line with solution small angle X-ray scattering (SAXS), vital information such as (i) quantitative, absolute size distribution profiles, (ii) drug loading, (iii) size-dependent internal structures, and (iv) quantitative information on free drug is obtained...
September 22, 2023: Scientific Reports