[Comparative studies on biologic availability and pharmacokinetics of bromazepam in tablets]

Ten male volunteers participated in a randomized crossover trial to compare the bioavailability of bromazepam (7-bromo-1,3-dihydro-5-(2-pyridyl)-2H-1,4-benzodiazepin-2-one) from two different preparations (Normoc, the test preparation, and a commercially available standard preparation). A single dose of 6 mg bromazepam was given. There was no difference in the USP XX rotating basket dissolution test between both preparations. The pharmacokinetic parameters elimination half-life, maximum plasma concentration and area under the curve were not significantly different. With the test preparation, however, smaller interindividual differences were seen. Only the time to peak plasma concentration showed a statistically significant difference. The test preparation yielded a flatter and smoother plasma bromazepam concentration curve compared with the standard preparation. This seems favourable in the case of subchronic dosing with regard to side effects, e.g. sedation.