• Journal of Pharmaceutical Investigation
• /
• v.35 no.5
• /
• pp.355-360
• /
• 2005

The purpose of the present study was to evaluate the bioequivalence of two cetirizine HCl tablets, Zyrtec tablet (UCB Pharm. Co., Ltd. Korea, reference product) and Zyrix tablet (Kukje Pharm. Co., Ltd., Korea, test product), according to the guidelines of Korea Food and Drug Administration (KFDA). After adding an internal standard (diazepam), plasma samples were extracted using 1 mL of dichloromethane. Compounds extracted were analyzed by reverse-phase HPLC with ultra-violet detector. This method for determination cetirizine is proved accurate and reproducible with a limit of quantitation of 10 ng/mL in male plasma. Twenty-four healthy male Korean volunteers received each medicine at the cetirizine HCl dose of 10 mg in a $2{\times}2$ crossover study. There was a one-week wash out period between the doses. Plasma concentrations of cetirizine were monitored for over a period of 24 hr after the administration. AUC (the area under the plasma concentration-time curve) was calculated by the linear trapezoidal rule. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed AUC and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the crossover design was properly performed. The 90% confidence intervals for the log transformed data were acceptable range of log 0.8 to log 1.25 $(e.g.,\;log\;0.93-log\;1.08\;for\;AUC_{0-t},\;log\;0.91-log\;1.08\;for\;AUC_{0-{\infty}}\;and\;log\;1.01-log\;1.11\;for\;C_{max})$. The major parameters, AUC and $C_{max}$ met the criteria of KFDA for bioequivalence indicating that Zyrix tablet is bioequivalent to Zyrtec tablet.

• Journal of Digital Convergence
• /
• v.19 no.3
• /
• pp.287-293
• /
• 2021

Tablets were conventionally used to treat choline urticaria. Disadvantages of tablets included sleep inducing problems, accessibility and reduced dosage. To address this, hydrogel containing Cetirizine HCl was manufactured. The experimental method was to measure viscosity, gel fraction, degree of swelling, content evaluation, and permeability. Studies have shown that hydrogels containing Cetirizine HCl can be directly applied to occurrence area to improve Cholinergic urticaric with minimal side effects associated with the marketable tablets. This hydrogel includes other important substances including steroids which gives it an advantage when applied on the skin, improving its accessibility. In addition, it is expected that the drug manufacturing process will be able to proceed as this hydrogel is effective even when used alone.