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Pharmacokinetics and pharmacodynamics of 3 sustained release theophylline preparations 350 milligram theograd 350 milligram theolair retard and 300 milligram theodur in steady state in healthy volunteers and asthmatics 1 theophylline plasma levels



Pharmacokinetics and pharmacodynamics of 3 sustained release theophylline preparations 350 milligram theograd 350 milligram theolair retard and 300 milligram theodur in steady state in healthy volunteers and asthmatics 1 theophylline plasma levels



International Journal of Clinical Pharmacology Therapy & Toxicology 22(8): 423-429



The pharmacokinetic profiles of 3 oral sustained-release theophylline preparations in steady state (350 mg Theograd, 350 mg Theolair Retard [=Nuelin Retard] and 300 mg Theolin Retard [= Theodur]) were compared in a group of 6 normal subjects and 6 patients with moderately severe asthmatic bronchitis. All preparations were given twice daily for 7 days. Before this study, an i.v. infusion of aminophylline was administered (5.6 mg theophylline /kg body wt). The plasma theophylline levels after oral administration were rather low from a clinical point of view (below 55 .mu.mol/l = 10 mg/l). The mean plasma theophylline level of the 3 different oral preparations in steady state did not show a statistically significant difference. The group of 6 healthy volunteers reached higher mean theophylline levels than the group of 6 patients, possibly due to differences in mean weight and smoking habits. This difference was only statistically significant (P = 0.001) for Theograd. Between Theograd, Theolair (Nuelin) Retard and Theolin (Theodur) Retard no statistically significant difference in absolute bioavailability was observed, and virtually no side effects were reported.

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