Liposomal formulations are the major class of drug products containing nanomaterial submitted to regulatory agencies across the globe. Liposome carriers are attractive for industry due to the long clinical history, with some products already approved as generics. Particle size and size distribution are critical quality attributes of liposomal formulations relevant to product development, quality control, and demonstrating generic equivalence. An accurate and reliable assessment of the physical state of liposomal drugs through validated methods is required for regulatory review. This test method describes a standardized protocol for the physical separation of size-differentiated populations and their on-line analysis in liposomal drug formulations using a multi-detector approach combined with asymmetrical-flow field-flow fractionation (AF4). The test method is applicable to commercial AF4 systems configured with on-line size and concentration detectors. Depending on the availability of specific detectors, and sensitivity requirement for the product, industry can utilize the analytical procedures as appropriate.
Nanometer-scale liposomes are being developed as drugs for multiple diseases. Assessing the safety and efficacy of nanometer-scale liposomes requires characterization using standard test methods. This proposed test method is critical to the development of nanometer-scale liposome-based medical products by industry and the review of such products by regulatory agencies.
The title and scope are in draft form and are under development within this