Physical characterization of liposomal drug formulations using multi-detector asymmetrical-flow field flow fractionation.

ABSTRACT: Liposomal formulations for the treatment of cancer and other diseases are the most common form of nanotechnology enabled pharmaceuticals (NEPs) submitted for market approval and in clinical application today. The accurate characterization of their physical-chemical properties is a key requirement; in particular, size, size distribution, shape, and physical-chemical stability are key among properties that regulators identify as critical quality attributes. Here we develop and validate an optimized method, based on multi-detector asymmetrical-flow field flow fractionation (MD-AF4) to accurately and reproducibly separate liposomal drug formulations into their component populations and to characterize their associated size and size distribution, whether monomodal or polymodal in nature. In add

SUBMITTER: Parot J 

PROVIDER: S-EPMC7146538 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature