Effect of dietary fat content on the bioavailability of a sustained release quinidine gluconate tablet

Abstract

Quinidine gluconate 324 mg sustained release tablets (Quinaglute) was administered as a single dose to 15 healthy male subjects following an overnight fast, immediately following a high fat (HF) breakfast or immediately following a low fat (LF) breakfast. Serum samples were obtained over a 48 h period and analyzed for quinidine content using a high performance liquid chromatographic assay. Under the conditions of the study, both the rate and extent of quinidine bioavailability was significantly affected by food. The extent of bioavailability was statistically significantly greater (p less than 0.05) following both the HF and LF meals as compared to that in the fasted state. Rate of bioavailability was significantly enhanced following the LF meal as compared to that of the other two treatment groups. Although peak concentrations were greater and time to peak concentrations somewhat later following the HF meal versus those under fasting conditions, these differences were not statistically significant. In addition, the characteristics of the serum concentration-time profile (as defined by the number, magnitude, and time of occurrence of the multiple absorption maxima) was unique for each of the three treatment groups. Possible mechanisms underlying these results are explored.

Biowaiver monographs for immediate release solid oral dosage forms: Quinidine sulfate

“…Intake of dietary salts may increase hepatic first‐pass metabolism of quinidine 69. Furthermore, concomitant intake of grapefruit juice may alter quinidine pharmacokinetics 70–73. Food may have differing effects on modified release dosage forms,71 however, this monograph is not concerned with modified release formulations.…”