Effect of drug intake prior to or after meals on serum theophylline concentrations: single-dose studies with Euphylong.

Three separate single-dose, randomized, cross-over studies in normal, healthy volunteers were performed to investigate the possible influence of drug intake in relation to concomitant food intake and of different dietary habits such as cold and hot evening meals on the bioavailability of theophylline from Euphylong. Euphylong is a new, pH- and rpm-independent theophylline formulation designed for once-daily administration in the evening. The results obtained show that the timing of drug intake, in relation to concomitant food intake, has no influence on the bioavailability of Euphylong. Under equicaloric conditions, a 10% decrease in AUC and a 20% decrease in Cmax is observed when Euphylong is administered after a hot evening meal compared with a cold evening meal. Viewed against the dramatic changes in bioavailability of up to 100%, which have been observed for certain other sustained-release theophylline formulations, these minor changes for Euphylong are negligible and without clinical relevance.