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Published on: March 23, 2016
On the BCS biowaivers of orally disintegrating tablets
Alfredo García-Arieta1, John Gordon2
1División de Farmacología y Evaluación Clínica, Departamento de Medicamentos de Uso Humano, Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.
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.
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