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Evaluation of Excipient Risk in BCS Class I and III Biowaivers

Authors
  • Metry, Melissa1
  • Polli, James E.1
  • 1 University of Maryland, Baltimore, Maryland, USA , Baltimore (United States)
Type
Published Article
Journal
The AAPS Journal
Publisher
American Association of Pharmaceutical Scientists
Publication Date
Jan 05, 2022
Volume
24
Issue
1
Identifiers
DOI: 10.1208/s12248-021-00670-1
Source
Springer Nature
Keywords
Disciplines
  • Theme: The Biological Effect of Pharmaceutical Excipients
License
Green

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. Graphical Abstract

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