Evaluation of pediatric sustained release preparations of theophylline by measurement of salivary levels.

概要

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The bioavailability of theophylline following administration of two pediatric sustained release tablets (Theona-P® and Theo-Dur®), two crushed sustained release tablets (crushed Theona-P® and crushed Theo-Dur®), and newly developed sustained release granules (E-0686-023, investigational drug) was studied in four volunteers by measuring salivary concentrations. The pharmacokinetic parameters tmax and MRT (mean residence time) for crushed Theona-P® and crushed Theo-Dur® were significantly shorter compared to Theona-P®, Theo-Dur®, and E-0686 granules, but the AUC0-∞ values were not different among them. The results show that each preparation is equivalent in the extent of bioavailability but not in the rate of bioavailability. More frequent administration is required when crushed Theona-P® or crushed Theo-Dur® are taken, and sustained release granules are desirable in children with chronic asthma who cannot swallow tablets.