On the BCS biowaivers of orally disintegrating tablets

Alfredo García-Arieta; John Gordon

doi:10.1016/j.ejps.2014.10.009

On the BCS biowaivers of orally disintegrating tablets

Eur J Pharm Sci. 2015 Jan 23:66:107-8. doi: 10.1016/j.ejps.2014.10.009. Epub 2014 Oct 18.

Authors

Alfredo García-Arieta¹, John Gordon²

Affiliations

¹ División de Farmacología y Evaluación Clínica, Departamento de Medicamentos de Uso Humano, Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.
² Division of Biopharmaceutics Evaluation, Bureau of Pharmaceutical Sciences, Therapeutic Products Directorate, Health Canada, Ottawa, Canada.

PMID: 25459529
DOI: 10.1016/j.ejps.2014.10.009

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.

Keywords: Biopharmaceutics Classification System; Biowaivers; Orally disintegrating tablets.

MeSH terms

Administration, Oral
Biological Availability
Biopharmaceutics*
Chemistry, Pharmaceutical*
Humans
Tablets / chemistry*
Therapeutic Equivalency

Substances

Tablets