Urinary excretion of ciprofloxacin after administration of extended release tablet in healthy volunteers. Hydrophilic carbomer-ciprofloxacin matrix versus bilayer tablets

ROMAÑUK CB; GUZMÁN, M.L.; LUCIANI GIACOBBE LC; SANCHEZ, MF; MANZO RH; OLIVERA ME

Congreso; 76th FIP World Congress of Pharmacy and Pharmaceutical Sciences 2016; 2016

Backgrounds: New extended release tablets composed by a carbomer-ciprofloxacin ionic complex (CCIC) were developed by wet granulation for the treatment of urinary infections, as an alternative to a bilayer patented formulation. CCIC showed dissolution efficiency similar to the bilayer reference tablets in spite of their different early times release profiles.Purpose: To compare in vivo ciprofloxacin urinary excretion after a single dose of both formulations.Methods: A phase 4, double-blind, randomized, crossover clinical trial was performed. Volunteers received a dose of CCIC or the reference. Urine was collected during 36 h and quantified by HPLC-fluorescence. Rate of urinary excretion at each time, corresponding to the half interval of samples collection were obtained (dE/dt vs time), from which (dE/dt)max, Tmax and E(∞) (area under the curve dE/dt versus t from 0 to ∞) were calculated. E%(t) and E(t) (percentage of the dose and the amount (mg) excreted in urine without change) were also determined.Results: Urinary excretion parameters for CCIC and the reference were, respectively: (dE/dt)max: 37±4 and 31±4 mg/h;Tmax: 2±0 and 2±1 h; E%:33±2 and 31±3 %; E(t):164±9 and (16±2)x101 mg; E(∞):(19±2)x101 y (18±2)x101mg. No significant differences were observed in the parameters calculated for CCIC and the reference (p