关于口腔崩解片的生物药剂学分类豁免

On the BCS biowaivers of orally disintegrating tablets.

作者信息

García-Arieta Alfredo, Gordon John

机构信息

División de Farmacología y Evaluación Clínica, Departamento de Medicamentos de Uso Humano, Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.

Division of Biopharmaceutics Evaluation, Bureau of Pharmaceutical Sciences, Therapeutic Products Directorate, Health Canada, Ottawa, Canada.

出版信息

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

DOI:10.1016/j.ejps.2014.10.009

PMID:25459529

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.

摘要

小野和菅野（2014年）近期发表在本期刊上的一篇论文表明，基于生物药剂学分类系统（BCS）的生物豁免可用于评估III类药物口腔崩解片（ODT）与速释制剂的生物等效性。该论文的断言让我们感到担忧，原因如下：该假设尚未在具有不同生物利用度的产品上进行测试，似乎未考虑ODT最常见的给药剂量，并且由于胃排空的差异，无水服用的ODT与速释产品之间存在生物利用度差异的风险。