Urinary excretion of ciprofloxacin after administration of extended release tablets in healthy volunteers. Swellable drug-polyelectrolyte matrix versus bilayer tablets

GUZMÁN, M. L.; ROMAÑUK, C. B.; SANCHEZ, M. F.; LUCIANI GIACOBBE, L. C.; ALARCÓN-RAMIREZ, L. P.; BATTISTINI, F. D.; ALOVERO, F. L.; JIMENEZ-KAIRUZ, A. F.; MANZO, R. H.; OLIVERA, MARÍA EUGENIA

Drug Delivery and Translational Research

Controlled Release Society

Año: 2017

2190-393X

his paper builds on a previous paper in which new ciprofloxacin extended-release tablets were developed based on a ciprofloxacin-based swellable drug polyelectrolyte matrix (SDPM-CIP). The matrix contains a molecular dispersion of ciprofloxacin ionically bonded to the acidic groups of carbomer, forming the polyelectrolyte-drug complex CB-CIP. This formulation showed that the release profile of the ciprofloxacin bilayer tablets currently commercialised can be achieved with a simpler strategy. Thus, since ciprofloxacin urine concentrations are associated with the clinical cure of urinary tract infections, the goal of this work was to compare the urinary excretion of SDPM-CIP tablets with those of the CIPRO XR® bilayer tablets. A batch of SDPM-CIP tablets was manufactured by the wet granulation method and the CB-CIP ionic complex was obtained in situ. Fasted healthy volunteers received a single oral dose of 500 mg ciprofloxacin of either formulation in a randomised crossover study. Urina