Interchangeability Criteria for Levofloxacin-Based Medicinal Products in the Russian Federation

Abstract

The present research was aimed at finding informative criteria for regulating the procedure to determine the interchangeability of systemic levofloxacin-based medicinal products (MP) registered in the RF. The chemical and pharmaceutical characteristics of excipients in 26 commercial levofloxacin products (film-coated tablets for internal use) were compared. Their product lines and instructions for medicinal use were also analyzed. It was shown that the compositions of levofloxacin tablets offered on the RF market differed significantly. It was established that the elaboration and implementation of informative criteria for regulating the procedure to determine the interchangeability of levofloxacin-based drugs should benefit the evaluation of drug quality during the determination of the interchangeability for medicinal use.