STUDY ON THE INFLUENCE OF FOOD ON THE ABSORPTION OF THEOPHYLLINE FROMA CONTROLLED-RELEASE PREPARATION

The possible influence of food and fat content of meals on the bioavai lability and pharmacokinetics of a 350 mg sustained-release theophylli ne (CAS 58-55-9) preparation (Bronchoretard(R)) was investigated after single-dose oral administration to 18 volunteers in a randomized 3-wa y cross-over design. The treatments investigating an administration of the test preparation in a fasting state, after a standard meal and af ter a high-caloric fat evening meal according to the commonly applied rules, could be shown to be equivalent with respect to the amount of b ioavailability (AUC) and the observed maximal concentrations (C(max)). Pharmacokinetic parameters describing sustained-release characteristi cs were not changed either to any relevant degree. As expected, the co -administration of food resulted in a physiologically determined delay - in absorption, which probably is not therapeutically relevant during long-term administration.