ASTM WK68060

    New Test Method for Analysis of Liposomal Drug Formulations using Multidetector Asymmetrical-Flow Field-Flow Fractionation (AF4)

    (What is a Work Item?)

    Developed by Subcommittee: E56.02 | Committee E56 | Contact Staff Manager



    WK68060

    1. Scope

    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.


    Keywords

    Liposomes

    Rationale

    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 ASTM Committee.

    Citing ASTM Standards
    Back to Top
    Work Item Status

    Date Initiated:
    05-02-2019

    Technical Contact:
    Vincent Hackley

    Status:
    Draft Under Development