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Biowaiver monograph for immediate-release solid oral dosage forms: Raltegravir potassium

Atsushi Kambayashi1, Masaki Iida1, Makoto Ishihara1

  • 1Faculty of Pharmaceutical Sciences, Tokyo University of Science, Noda, Japan.

Journal of Pharmaceutical Sciences
|August 18, 2024
PubMed
Summary

Biopharmaceutics Classification System (BCS)-based biowaivers are not recommended for raltegravir potassium immediate-release products due to its solubility and permeability characteristics. This guidance applies to new generics and products with significant formulation or manufacturing changes.

Keywords:
AbsorptionBioavailabilityBioequivalenceBiopharmaceutics classification system (BCS)BiowaiverDissolutionPermeabilityRaltegravir potassiumSolubility

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