Influence of a standard meal on the absorption of controlled-release pseudoephedrine capsules

✍ Scribed by Margaret T. Wecker; David A. Graves; Lewis P. Amsel; Orville N. Hinsvark; Keith S. Rotenberg

• Publisher: John Wiley and Sons
• Year: 1987
• Tongue: English
• Weight: 348 KB
• Volume: 76
• Category: Article
• ISSN: 0022-3549
• DOI: 10.1002/jps.2600760109

✦ Synopsis

The influence of a standard meal on the extent and rate of absorption of pseudoephedrine from a controlled-release (CR) capsule formulation (Pennkinetic System) was studied In 16 normal male volunteers. Equivalent single doses of an immediatsrelease (IR) pseudoephedrine reference syrup and the CR capsules were each studied under both fasted and postprandial conditions. Pharmacokinetic analysis evaluated the fraction of drug absorbed over time as determined by the Wagner-Nelson method. The area under the drug concentration versus time curve (AUC) results were not influenced by food or formulation, indicating that the CR formulation was absorbed to the same extent as the IR syrup. The maximum plasma concentration (&) and the time to maximum concentration ( C , ) tabulations under fasted conditions indicated that the CR preparatlon peaked at a lower level and a later time than the IR syrup. Food minimally affected the C,, of the IR formulation, but did not affect that of the CR formulation. Food delayed the t , , , = of both the IR and CR preparations by <1 h, but only the delay of the CR formulation was statistically significant. Neither