Effect of accelerated-aging conditions on the dissolution stability of ciprofloxacin tablets

Abstract

The aim of the present study was to evaluate and compare the influence of accelerated-aging conditions on the drug content and in vitro dissolution stability of eleven different ciprofloxacin (CIP) 500-mg tablets obtained from pharmacies and hospitals in Argentina. CIP, a Class II/IV drug in the Biopharmaceutics Classification System, is a fluoroquinolone antibiotic agent used in the treatment of bacterial infections. CIP content was evaluated following USP (1) specifications. Dissolution efficiency (DE) was calculated from dissolution profiles that were performed according to the British Pharmacopoeia monograph for CIP tablets (2). This determination was performed at time zero and after three (3M) and six months (6M) of storage, according to ICH accelerated-aging conditions (40 ° C/75% RH). Each formulation was compared with the reference at the specified times, using ANOVA in terms of DE and similarity factor f2. Furthermore, ANOVA for DE values was used to evaluate the effect of aging conditions on the dissolution stability within each formulation. Although the storage conditions examined in the study affected the dissolution behavior of all CIP formulations, they did not have a significant effect on chemical stability, with the exception of one formulation that showed undesirable performance in both chemical and dissolution stability.