EVALUATION OF THE EFFECT OF DIFFERENT KINDS OF FOODS ON THE BIOAVAILABILITY OF A SUSTAINED-RELEASE THEOPHYLLINE TABLET

Food-induced changes on the bioavailability of a sustained-release the ophylline tablet, which uses acrylic resins Eudragit as sustaining age nt, were studied in 12 healthy male volunteers. The tablet was develop ed in our laboratory using conventional technology. It presented a goo d bioavailability pattern and maintained plasmatic concentrations with in the therapeutic range for 12 hours under conditions of steady-state . The study design was a 4 x 4 latin square involving 12 subjects who received a single dose of the tablet while fasting or with a standariz ed normal, high fat or high fat/high protein meal. The results showed no differences in AUC, K, t(max), ka and MRT. Statistical differences were found in C-max comparing the fasting condition with high fat/high protein diet. A delay was also observed in the detection of the drug in plasma when the tablet was administered with high fat and high fat/ high protein food, but clinically the changes seem to be irrelevant.