An-Najah Staff

The voltammetric behavior of ciprofloxacin was investigated using cyclic voltammetry and differential-pulse anodic stripping voltammetry at bare glassy carbon (GC) electrodes and DNA-modified glassy carbon (DNA-GC) electrodes. For both types of electrodes, only one anodic irreversible wave was observed. A comparison between the current responses for the ciprofloxacin at the modified DNA-GC and unmodified GC electrodes, it was showed that the DNA- modified electrode exhibits a significant enhancement of the voltammetric current response with a better peak shape. Also, the interaction of ciprofloxacin with DNA was studied by using cyclic voltammetry technique at (DNA-GC) electrodes, which showed a weak interaction with a binding constant (K) = 2.89 x 105 M-1. A linear relationship between the peak current and ciprofloxacin concentrations was observed in the range 1.0–10.0 μM, with a slope a detection limit of 0.117 μM, with r = 0.998, and 1.0 μM.

BACKGROUND AND THE PURPOSE OF THE STUDY:

The aim of this study is to formulate and evaluate the quality of ciprofloxacin (CAS number: 85721-33-1) sustained release tablet (Ciprocare®XR) 1 000 mg ciprofloxacin (test formulation) by comparing its pharmacokinetic parameters with Cipro®XR sustained release tablet (reference formulation). For this purpose ciprofloxacin SR tablets were developed using the 2-layer method. To assess the quality of the produced sustained release tablets a randomized, 2-way, crossover, bioequivalence study was performed in 24 healthy, male volunteers. The selected Middle Eastern volunteers were divided into 2 groups of 12 subjects. One group was treated with the reference formulation and the other one with the test formulation, with a cross-over after a drug washout period of 7 days. Blood samples were collected at fixed time intervals and Ciprofloxacin concentrations were determined by a validated HPLC assay method. The pharmacokinetic parameters AUC0-48, AUC0-∞, Cmax, Tmax, Ke and T1/2 were determined for both sustained release tablets and were compared statistically to evaluate the bioequivalence between the 2 formulations of ciprofloxacin, using the statistical model recommended by the FDA. The analysis of variance (ANOVA) did not show any significant difference between the 2 formulations and 90% confidence intervals (CI) fell within the acceptable range for bioequivalence. According to the obtained results it was concluded that the test and reference formulations are bioequivalent, since they exhibit comparable pharmacokinetic parameters.

The aim of this study is to formulate and evaluate the quality of ciprofloxacin (CAS number: 85721-33-1) sustained release tablet (Ciprocare®XR) 1 000 mg ciprofloxacin (test formulation) by comparing its pharmacokinetic parameters with Cipro®XR sustained release tablet (reference formulation). For this purpose ciprofloxacin SR tablets were developed using the 2-layer method. To assess the quality of the produced sustained release tablets a randomized, 2-way, crossover, bioequivalence study was performed in 24 healthy, male volunteers. The selected Middle Eastern volunteers were divided into 2 groups of 12 subjects. One group was treated with the reference formulation and the other one with the test formulation, with a cross-over after a drug washout period of 7 days. Blood samples were collected at fixed time intervals and Ciprofloxacin concentrations were determined by a validated HPLC assay method. The pharmacokinetic parameters AUC0-48, AUC0-∞, Cmax, Tmax, Ke and T1/2 were determined for both sustained release tablets and were compared statistically to evaluate the bioequivalence between the 2 formulations of ciprofloxacin, using the statistical model recommended by the FDA. The analysis of variance (ANOVA) did not show any significant difference between the 2 formulations and 90% confidence intervals (CI) fell within the acceptable range for bioequivalence. According to the obtained results it was concluded that the test and reference formulations are bioequivalent, since they exhibit comparable pharmacokinetic parameters.

The voltammetric behavior of ciprofloxacin was investigated using cyclic voltammetry and differential-pulse anodic stripping voltammetry at bare glassy carbon (GC) electrodes and DNA-modified glassy carbon (DNA-GC) electrodes. For both types of electrodes, only one anodic irreversible wave was observed. A comparison between the current responses for the ciprofloxacin at the modified DNA-GC and unmodified GC electrodes, it was showed that the DNA- modified electrode exhibits a significant enhancement of the voltammetric current response with a better peak shape. Also, the interaction of ciprofloxacin with DNA was studied by using cyclic voltammetry technique at (DNA-GC) electrodes, which showed a weak interaction with a binding constant (K) = 2.89 x 105 M-1. A linear relationship between the peak current and ciprofloxacin concentrations was observed in the range 1.0–10.0 μM, with a slope a detection limit of 0.117 μM, with r = 0.998, and 1.0 μM.

This study was undertaken to evaluate the significance of pharmacokinetic interaction between ciprofloxacin and licorice (Glycerhyza glabra). The study was designed as a comparative, randomized, two-period, two-treatment, two-sequence, single dose, crossover study in order to investigate the effect of licorice extract on ciprofloxacin in 12 rabbits (1.8-3.2kg). Rabbits were administered single oral doses of 40 mg/kg ciprofloxacin either with licorice extract or water. A simple and sensitive high performance liquid chromatography method for the detection and quantification of ciprofloxacin in rabbit plasma was developed specifically for this study. The resulting concentrations versus time curves were analyzed using non–compartmental pharmacokinetic analysis. Study results showed that licorice extract slightly reduced the rate and extent of ciprofloxacin absorption to around 80% [maximum plasma concentration (Cmax); from 1714 ng/ml to 1241 ng/ml, with a p-value of 0.25 and a 90% confidence interval (90% CI) 43.930–119.3 and the area under the plasma concentration time curve from zero to infinity (AUC∞); from 6964 ng.hr/ml to 5777 ng.hr/ml, with a p-value of 0.33 and a 90% CI 58.8–117.4 ng.hr/ml]. This interaction is speculated to be due to the interaction between the metals in the licorice extract and ciprofloxacin. In conclusion, the non-statistically significant pharmacokinetic interaction between ciprofloxacin and licorice that was observed in this study is not expected to have significant clinical consequences.