Introduction

Amlodipine (AML) is a weak base drug (pKa 9.1, lop=2.96) belonging to class I of the BCS and therefore a candidate for biowaiver. However, different studies have been carried out to determine the release of AML besylate tablets using diverse dissolution conditions such as those of the FDA, WHO, and ICH M9, and the results are discordant[1]. Considering that compendial/pharmacopeial dissolution methods may not be biorelevant, reports of false-positive or false-negative outcomes of the BCS procedure and the importance of appropriate dissolution tests to request a waiver of BE trials from in vitro data (%dissolved), the objective of this research was to evaluate the dissolution behavior of AML and relate it with its in vivo performance through Physiologically based biopharmaceutics modeling (PBBM)[2].

Porfirio de la Cruz Cruz, José Trinidad Pérez Urizar, Larissa Lopes Rodrigues Gomide, Marcelo Dutra Duque