Bioavailability of hydrocortisone from commercial 20-mg tablets

✍ Scribed by Rajni B. Patel; Mark C. Rogge; Arzu Selen; Thomas J. Goehl; Vinod P. Shah; Vadlamani K. Prasad; Peter G. Welling

• Publisher: John Wiley and Sons
• Year: 1984
• Tongue: English
• Weight: 320 KB
• Volume: 73
• Category: Article
• ISSN: 0022-3549
• DOI: 10.1002/jps.2600730726

✦ Synopsis

The relative bioavailability of hydrocortisone was determined from four different 20-mg tablet formulations and one suspension in 15 healthy male volunteers; results were compared with in vitro dissolution rates. Plasma levels of hydrocortisone were determined by a liquid chromatography method developed in this laboratory. Dissolution of the tablet formulations, using the official USP test, varied from 7.8 to 93.8% in 30 min. Similar plasma profiles were obtained from all tablet products, and there were no differences among tablets in the cumulative percentage of drug absorbed. There were no clear trends in any pharmacokinetic parameter values among the tablet dosages, and the four products were considered bioequivalent. The suspension dosage yielded significantly higher plasma levels compared with some of the tablet formulations during the initial 30-min postdose, significantly higher cumulative absorption at 0.5 and 1.0 h compared with one tablet formulation, and significantly higher ka and Cmax, and shorter tmax values, compared with some of the tablets.