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.
Highlights
Pantoprazole, a proton pump inhibitor (PPI), is indicated for the treatment of erosive esophagitis associated with gastroesophageal reflux disease (GERD)
Since the 90% confidence intervals (CI) values of AUC0−∞ and Cmax were within the bioequivalence range, our study demonstrated the bioequivalence of the two preparations
The present randomized, two-way crossover design study indicated that two brands of pantoprazole sodium 40 mg preparations were bioequivalent
Summary
Pantoprazole, a proton pump inhibitor (PPI), is indicated for the treatment of erosive esophagitis associated with gastroesophageal reflux disease (GERD). Pantoprazole is one of the highly prescribed PPI in the management of peptic ulcer diseases. It shows high specificity for the relevant binding sites on activated proton pumps with little propensity to cause unwanted systemic effects [1, 2]. Pantoprazole is extensively metabolized in the liver and has a total serum clearance of 0.1 l/h/kg, a serum elimination half-life of about 1.1 h, and an apparent volume of distribution of 0.15 L/kg. Elimination halflife, clearance, and volume of distribution are independent of the dose. The clearance of pantoprazole is only slightly affected by age, with its half-life being approximately 1.25 h in the elderly [3]. Oral formulations of pantoprazole are available as enteric-coated tablets
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
