title: On the BCS biowaivers of orally disintegrating tablets.
abstract: A recent paper in this journal by Ono and Sugano (2014) suggests BCS-based biowaivers can be applied to assess the bioequivalence of orally disintegrating tablets (ODTs) with immediate release formulations for Class III drugs. The assertion made by the paper is a concern for us for reasons including the following: the supposition has not been tested with products that have differing bioavailabilities, the most common posology for administration of ODTs does not appear to have been considered, and there is a risk of differences in bioavailability between ODTs taken without water and immediate release products because of differences in gastric emptying.
authors.affiliation: División de Farmacología y Evaluación Clínica, Departamento de Medicamentos de Uso Humano, Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.
authors.forename: Alfredo
authors.initials: A
authors.lastname: García-Arieta
authors.affiliation: Division of Biopharmaceutics Evaluation, Bureau of Pharmaceutical Sciences, Therapeutic Products Directorate, Health Canada, Ottawa, Canada.
authors.forename: John
authors.initials: J
authors.lastname: Gordon
mesh_terms: D000284:Administration, Oral; D001682:Biological Availability; D001702:Biopharmaceutics; D002626:Chemistry, Pharmaceutical; D006801:Humans; D013607:Tablets / Q000737:chemistry*; D013810:Therapeutic Equivalency
chemical_list: D013607:Tablets
keywords: Biopharmaceutics Classification System; Biowaivers; Orally disintegrating tablets