Bioequivalence Study of Pantoprazole Sodium-HPBCD and Conventional Pantoprazole Sodium Enteric-Coated Tablet Formulations

Abstract

The objective of this study was to investigate the bioequivalence of two formulations of 40 mg pantoprazole sodium enteric-coated tablets: Tripepsa as the test and Pantocid as the reference. The two products were administered as a single oral dose according to a randomized two-phase crossover with a 1-month washout period in 25 healthy Indian volunteers. After drug administration, serial blood samples were collected over a period of 30 hours. Plasma pantoprazole concentrations were measured by high-performance liquid chromatography with UV detection. Pharmacokinetic parameters were analyzed based on noncompartmental analysis. The logarithmically transformed data of AUC0−∞ and C max were analyzed for 90% confidence intervals (CI) using ANOVA. The mean (90% CI) values for the ratio of AUC0−∞ and C max values of the test product over those of the reference product were 90.21 (83.69–97.24) and 108.68 (100.21–117.86), respectively (within the bioequivalence range of 80–125%). On the basis of pharmacokinetic parameters including AUC0−∞, AUC0−t, and C max values, both the formulations were bioequivalent.

Alteration of Pharmacokinetic Parameters of Proton Pump Inhibitors Using Transdermal Drug Delivery System

“…The elimination rate of both the PPIs was relatively fast with a t1/2 of 9.99 and 5.99 h for the test formulations and 1.127 and 1.574 h for the marketed formulations. The t1/2 values were found to vary widely; similar results were reported by Hassan et al and Kamdi et al [26,27]. The other parameters, like AUMC were also found to be higher in the F1 and F7 formulations.…”

Recombinogenic activity of Pantoprazole® in somatic cells of Drosophila melanogaster

“…No significant decreases in the survival rates of larvae submitted to treatments were observed when compared to the negative control. The maximum concentration used in our study corresponded to plasma levels found in patients treated with single oral dose of 40 mg of Pantoprazole ( Kamdi and Palkar, 2013 ). The maximum values found by the authors were seen at 2 h 56 min after exposure.…”