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Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Fexofenadine. | LitMetric

AI Article Synopsis

  • The monograph examines using the Biopharmaceutics Classification System (BCS) to assess the bioequivalence of fexofenadine hydrochloride solid oral dosage forms instead of traditional human pharmacokinetic studies.
  • *The study reveals that fexofenadine is classified as BCS Class IV, indicating it has low solubility and permeability, which complicates the approval of generic versions.
  • *Despite showing behavior similar to BCS Class I/III in pharmacokinetic tests and having a wide therapeutic index, BCS Class IV drugs must still undergo clinical bioequivalence studies according to ICH guidelines.

Article Abstract

In this monograph, the potential use of methods based on the Biopharmaceutics Classification System (BCS) framework to evaluate the bioequivalence of solid immediate-release (IR) oral dosage forms containing fexofenadine hydrochloride as a substitute for a pharmacokinetic study in human volunteers is investigated. We assessed the solubility, permeability, dissolution, pharmacokinetics, pharmacodynamics, therapeutic index, bioavailability, drug-excipient interaction, and other properties using BCS recommendations from the ICH, FDA and EMA. The findings unequivocally support fexofenadine's classification to BCS Class IV as it is neither highly soluble nor highly permeable. Further impeding the approval of generic equivalents through the BCS-biowaiver pathway is the reference product's inability to release ≥ 85 % of the drug substance within 30 min in pH 1.2 and pH 4.5 media. According to ICH rules, BCS class IV drugs do not qualify for waiving clinical bioequivalence studies based on the BCS, even though fexofenadine has behaved more like a BCS class I/III than a class IV molecule in pharmacokinetic studies to date and has a wide therapeutic index.

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Source
http://dx.doi.org/10.1016/j.xphs.2024.06.002DOI Listing

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