Pharmacokinetics of a sustained-release theophylline preparation in healthy subjects.

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Abstract
A comparative pharmacokinetic study between a sustained-release theophylline [used to treat chronic asthma] tablet (Theona) and aminophylline powder following multiple oral administrations every 12 h at a 200 mg theophylline dose was performed in 10 healthy adult volunteers. Theophylline in Theona was almost completely absorbed as was aminophylline. A peak-trough difference with Theona was < 1/2 of that with aminophylline powder. Theona apparently has excellent characteristics as a sustained-release preparation. In order to investigate dose-dependent kinetics for theophylline, the relationship between average plasma level and dosage was examined with Theona. The plasma level showed proportional change at the low concentrations. When the plasma level was close to 10 .mu.g/ml, dosage increment resulted in an increasingly greater change of plasma level, which may indicate a high risk of toxicity.

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