Analysis of in Vitro Dissolution of Whole vs. Half Controlled-Release Theophylline Tablets

Abstract

Controlled-release (CR) drug products dissolve more slowly than conventional-release products, reflecting their quality of sustaining a prolonged therapeutic effect. A frequent practice with scored tablets when only half the dosage is desired is to divide the tablet at the score mark and administer only half of the product. The dissolution characteristics of the divided tablets are unknown. It is only an assumption that the halved tablet behaves similarly to the whole tablet both in vitro and in vivo. A series of in vitro dissolution analyses was performed on whole and half CR theophylline tablets from different manufacturers. Statistical tests were carried out between the dissolution results of whole and those of halved tablets to determine whether the mean overall percentages dissolution (averaged over sampling times) were similar and whether the patterns of percentage dissolution over time were similar. The dissolution of halved tablets was slightly faster compared to that of intact (whole) tablets. However, these small differences were not large enough to cause concern or to require bioavailability studies.