A relative bioavailability study of 500 mg calcium p-aminosalicylate film coating tablet in healthy individuals

Abstract

The purpose of this study is to evaluate the only available calcium p -aminosalicylate (Ca PAS) commercial product, which is one of the most commonly prescribed non-surveillance products from the Bureau of National Health Insurance (BNHI) database in Taiwan. An open-randomized, balanced, two-way crossover study was designed to evaluate the relative bioavailability (F) of a 500 mg Ca PAS F.C. tablet with a 500 mg Ca PAS suspension in 13 healthy individuals. Blood samples were collected according to a planned time schedule. The plasma concentrations of PAS were measured by a validated liquid chromatography coupled with tandem mass spectrometry (LC/MS/MS) method. Pharmacokinetic parameters of area under the plasma concentration-time curve from the time zero to the time of last quantifiable concentration (AUC 0–t ), area under the plasma concentration-time curve from time zero to infinity (AUC 0–∞ ), maximum plasma concentration (C max ), time to reach measured maximum plasma concentration (T max ), elimination half-life (T 1/2 ), and mean residence time (MRT) were determined by non-compartment methods. F was calculated by [AUC 0–∞ ] of the test drug divided by [AUC 0–∞ ] of the reference drug. The mean geometric ratios of pharmacokinetic parameters, including AUC 0–t , AUC 0–∞ , and C max obtained were 0.873, 0.874, and 0.569, respectively. The 90% confidence intervals of ln (AUC 0–t ), ln (AUC 0–∞ ), and ln (C max ) after being back natural log-transformed were (74.0–103.0%), (74.1–103.0%), and (38.4–84.3%), respectively. The relative bioavailability of the Ca PAS tablet was 87.4%.

A Skin‐Interfaced, Miniaturized Microfluidic Analysis and Delivery System for Colorimetric Measurements of Nutrients in Sweat and Supply of Vitamins Through the Skin

“…These behaviors are similar to previously published pharmacokinetic profiles of concentrations in plasma after oral dosage. [ 49–52 ]…”

“…These behaviors are similar to previously published pharmacokinetic profiles of concentrations in plasma after oral dosage. [49][50][51][52] Quantitative comparisons of the dynamic concentrations in sweat and in plasma involve measurements of the time required to reach the maximum concentrations (T Max ) and the time (T 1/2 ) required to decrease to one half of these maximum concentrations. As shown in Figure 4f, T Max and T 1/2 for sweat are similar to those for plasma in all cases.…”

Codissolution of calcium hydrogenphosphate and sodium hydrogencitrate in water. Spontaneous supersaturation of calcium citrate increasing calcium bioavailability

“…Citrate has already been found to increase calcium absorption in several studies [ 7 , 8 ]. The method developed in the present study may thus serve as a convenient preclinical test of new mineral drug formulations or of novel mineral supplements, but will need to be followed up by intervention studies [ 21 ]. Such clinical studies should also include effects of other food or beverage components, since calcium is known to interact with browning products formed during heating of foods like shrimp or with antibacterial drugs [ 21 , 22 ].…”

Antioxidant activity and calcium binding of isomeric hydroxybenzoates

“…Interaction of calcium as an important mineral nutrient, often with low bioavailability, with dietary antioxidants is also important for mouth and teeth health [ 22 ]. Binding of calcium to proteins at their carboxylate side chain and to certain drugs may further affect their bioavailability [ 23 , 24 ]. The developed methods in the present study should be useful for future studies of such effects.…”