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    Evaluation of Excipient Risk in BCS Class I and III Biowaivers.

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    Author
    Metry, Melissa
    Polli, James E
    Date
    2022-01-05
    Journal
    AAPS Journal
    Publisher
    Springer Nature
    Type
    Article
    
    Metadata
    Show full item record
    See at
    https://doi.org/10.1208/s12248-021-00670-1
    Abstract
    The objective of this review article is to summarize literature data pertinent to potential excipient effects on intestinal drug permeability and transit. Despite the use of excipients in drug products for decades, considerable research efforts have been directed towards evaluating their potential effects on drug bioavailability. Potential excipient concerns stem from drug formulation changes (e.g., scale-up and post-approval changes, development of a new generic product). Regulatory agencies have established in vivo bioequivalence standards and, as a result, may waive the in vivo requirement, known as a biowaiver, for some oral products. Biowaiver acceptance criteria are based on the in vitro characterization of the drug substance and drug product using the Biopharmaceutics Classification System (BCS). Various regulatory guidance documents have been issued regarding BCS-based biowaivers, such that the current FDA guidance is more restrictive than prior guidance, specifically about excipient risk. In particular, sugar alcohols have been identified as potential absorption-modifying excipients. These biowaivers and excipient risks are discussed here. [Figure not available: see fulltext.] © 2022, The Author(s).
    Rights/Terms
    © 2022. The Author(s).
    Keyword
    Biopharmaceutics Classification System (BCS)
    bioavailability
    bioequivalence
    biowaiver
    excipient
    Identifier to cite or link to this item
    http://hdl.handle.net/10713/17507
    ae974a485f413a2113503eed53cd6c53
    10.1208/s12248-021-00670-1
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