Comparative pharmacokinetics and safety of lansoprazole oral capsules and orally disintegrating tablets in healthy subjects

Abstract

SUMMARYBackground: Many individuals with acid-related gastrointestinal disorders have difficulty in swallowing oral agents. Aim: To compare the bio-availability of a single dose of lansoprazole orally disintegrating tablet with that of an intact capsule. Methods: One hundred and twenty healthy subjects participated in two prospective, Phase I, open-label, two-period cross-over studies to receive lansoprazole, 15 mg or 30 mg. Within each study, subjects were randomized into two parallel cohorts consisting of 30 subjects per regimen, dispensed in opposing sequence over two periods separated by a 7-day washout period.

Proton Pump Inhibitors Inhibit Methotrexate Transport by Renal Basolateral Organic Anion Transporter hOAT3

“…Indeed, PPIs are mainly metabolized by CYP2C19, and because the impact of CYP2C19 polymorphism on drug concentrations has been well established, different concentrations should be considered (Goldstein, 2001;Simon et al, 2011). A previous group described the maximum concentration of carriers of a loss of function allele in the plasma for omeprazole (3.1 mM), lansoprazole (4.9 mM), and pantoprazole (11.5 mM) according to the CYP2C19 "poor metabolizer" phenotype (Regardh et al, 1990;Pue et al, 1993;Yasuda et al, 1995;Ieiri et al, 2001;Freston et al, 2003). The plasma concentrations were lower in carriers of the normal allele with an "extensive metabolizer" phenotype, 1.6, 2.4, and 5.4 mM for omeprazole, lansoprazole, and pantoprazole, respectively.…”

Lansoprazole Fast Disintegrating Tablet: A New Formulation for an Established Proton Pump Inhibitor

“…In two studies reported by Freston et al [18], the average disintegration times of LFDT without water were found to be 48 and 53 s for the 15- and 30-mg doses, respectively.…”

“…In two studies reported by Freston et al [18], the safety and bioavailability of LFDT taken without water were compared with lansoprazole capsules after a single dose of 15 or 30 mg. Each study enrolled 60 healthy adults and utilized a randomized, single-center, two-period, crossover design with a 7-day washout interval. The mean plasma concentration profiles were comparable for LFDT and lansoprazole capsules at both 15- and 30-mg doses (fig.…”

“…Comparison of mean lansoprazole plasma concentration time profiles between LFDT and lansoprazole capsule at 15- and 30-mg doses (data from Freston et al [18]).…”

Managing Gastro-Oesophageal Reflux Disease in the Older Patient

“…Newer formulations such as the lansoprazole fast oro-dispersible tablet do not need to be taken with water and are particularly useful in the elderly and those with swallowing difficulties. The lansoprazole preparation has been shown to be bio-equivalent to the conventional preparation and thus has the same efficacy for healing and maintenance therapy [43]. …”