Connect Conference & Show Floor Educational Sessions

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  • Understanding Critical Excipient Properties to Ensure Consistent Quality of Amorphous Solid Dispersion and Extended-Release Products

    • Yihong Qiu  |  Oral Drug Products, Manufacturing Science & Technology, AbbVie, Inc.
    Location:  113A
    Track: Drug Development
    Pass Type: Connect Delegate, VIP Attendee - Get your pass now!
    Vault Recording: TBD

    Assessing variation of critical excipients properties is an essential element in:
    I. Developing a product of consistent quality
    II. Establishing appropriate specifications to assure quality and
    III. Building robustness into manufacturing process, especially for dosage forms based on more sophisticated drug delivery technologies, such as extended-release and amorphous solid dispersion systems.

    This presentation intends to examine the crucial role excipients and their "natural" variability may play in affecting product quality and highlight the importance of understanding variability of key functional excipients and continuous learning & improvement through application of the new knowledge to ensure consistent product quality and performance and minimize patient risks in commercial manufacturing.

    An overview of the basic principles and key functional excipients of extended-release and amorphous solid dispersion systems will be provided. Case studies will be shared to demonstrate:
    How critical material properties and variation within and outside of compendial and/or supplier's specifications can influence product quality and performance, such as in vitro dissolution, stability and in vivo absorption, during manufacture of marketed products; and
    Continuous monitoring, accumulating knowledge of raw materials, product and process are imperative in maintaining production consistency.

    It is also shown that the susceptibility of a particular quality attribute to variation of excipient properties and extent of the impact often depend on the API, product design and operating principles, manufacturing process and test method. Therefore, it is important to apply systematic approach in evaluating material properties on product quality and performance via an integrated evaluation of drug substance, formulation, process, test method and their interactions.