Effect of Biopharmaceutical Classification System on Pharmacokinetic and Mechanism of Drug Release In vitro

Abstract

The study aimed to monitor the pharmacokinetic and mechanism of drug release in vitro based on the Biopharmaceutical Classification System (BCS). Two pharmaceutical products were used (original and generic) with different classes according to BCS: Paracetamol  (Class I), Diclofenac Sodium (Class II), Ranitidine (Class III), and Azithromycin (Class IV). Dissolution tests were conducted using the United State Pharmacopeia (USP) monograph, and the release profiles were compared using difference (f1) and similarity (f2) factors as criteria in different classes.  The results have shown that the f1 and f2 were influenced by BCS, namely poorly soluble drugs, namely Diclofenac Sodium (Class II) and Azithromycin (Class IV). At the same time, these factors were not affected by high-solubility drugs, namely Paracetamol (Class I)  and Ranitidine (Class III). On the other hand, the mechanism of drug release is not affected by this classification.