In vitro Pharmaceutical Bioequivalence of Amoxicillin 500 mg capsules

Abstract

To establish the interchangeability of drugs, mainly generics, it is necessary to demonstrate their equivalence with respect to the reference drug (Talevi, Quiroga, & Ruiz, 2016). Among the main tests that are carried out are those of bioavailability, bioequivalence and the comparison of dissolution profiles. These tests make it possible to guarantee the safety of the exchange between drugs during clinical practice.

Amoxicillin, a broad-spectrum antibiotic widely used in our country for the treatment of various infectious pathologies, is in Class I within the Biopharmaceutical Classification System (SCB) (PAHO, 2011), therefore, its equivalence can be demonstrated through through in vitro studies. In this study, the dissolution profiles of three Amoxicillin 500 mg capsules marketed in Nicaragua were compared, with the aim of demonstrating whether they are interchangeable. The methodology used in the study is that described in the FDA Guide for Comparison of Dissolution Profiles; Three dissolution media were used at pH 1.2, 4.5 and 6.8 and f2 was calculated to determine exchangeability. At pH 1.2, all the products reached in the first sampling time, a dissolved percentage greater than 85%, in the pH 4.5 dissolution medium, both drug C and the reference did not reach it.

In contrast, at pH 6.8, only drug B achieved more than 85% of the active principle dissolved in the first ten minutes of the test. At pH 4.5 and 6.8 it was determined that drug C is not similar to the reference one since f2 is 29.9 and 46.3, respectively. Therefore, of the three test drugs, C is not interchangeable, it should be noted that drugs A and B are national.