Abstract
Dissolution behavior and effect of food on the bioavailability of a newly designed sustained-release granules of the ophylline (THP-G) were studied. In vitro dissolution rate of theophylline was measured according to the JPX dissolution test procedures in pH 1.2, 3.0, 5.0, and 6.8 solutions. The effect of food on the bioabailability after oral administration of 2.0 g of THP-G (400 mg of theophylline) was investigated in three volunteers following a cross-over design. The standard breakfast consisted of 140 g of bread, 200 ml of milk, and 20 g of butter. In vitro dissolution rates at pH 1.2 and 3.0 were 0-order, but at pH 5.0 and 6.8 were 1-order. The bioavailability in non-fasting state was about 80% that in fasting one.
