Pharmaceutical equivalence and stability study of levofloxacin tablets commercialized in Europe and Africa

Abstract

Tuberculosis (TB) is one of the most severe and deadly infectious diseases in African region, where there is a high prevalence of multi-drug resistant tuberculosis (MDR-TB) too [1]. This resistant has increased in the recent years due to the commercialization of substandard and falsif ied medicines in low and middle income countries. The quality of the medicines may be affected in the whole steps of its lifecycle. In this sense, many medicines require specific conditions to ensure their quality during storage or shipping. In addition, climatic conditions of African countries are extremely harsh for many medicines, so packaging must be selected for environments with high temperature and humidity. Then, the detection of such poor-quality medicines it is essential to ensure an optimum treatment of TB disease and must be carried out by WHO-accredited reference laboratories [2]. In this way, the ISACAM project (www.isacam.eu) aims to establish a medicine quality assurance system in collaboration with the Laboratoire National de Contrôle de la Qualité des Médicaments (LNCQM) and achieve its qualification. Levofloxacin (LVFX) is one of the most widely used drugs to treat MDR-TB and its quality assurance is essential to cure the disease and prevent new resistance. The objective of this work was to evaluate the influence of storage conditions on the quality attributes of 3 LVFX medicines obtained from European and African supply-chain and compare the formulations through the dissolution profiles.