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Pharmacokinetic analysis of sustained‐release dosage forms of theophylline in humans: Comparison of single and multiple dose studies
Author(s) -
Hussein Ziad,
Bialer Meir,
Friedman Michael,
Raz Itamar
Publication year - 1987
Publication title -
biopharmaceutics and drug disposition
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.419
H-Index - 58
eISSN - 1099-081X
pISSN - 0142-2782
DOI - 10.1002/bdd.2510080503
Subject(s) - theophylline , pharmacokinetics , pharmacology , dose , dosage form , therapeutic window , therapeutic index , population , absorption (acoustics) , medicine , drug , chemistry , materials science , environmental health , composite material
A pharmacokinetic analysis of two sustained‐release dosage forms of theophylline (Theo‐Dur® and Theotrim®) was carried out following single and multiple dose administrations of the two formulations in five healthy subjects. Despite the prolonged absorption after administration of the two sustained‐release formulations, theoretical predictions of theophylline steady‐state levels following multiple dosages based upon data obtained from the single dose study, correlated with the data of the multiple dose study. This study shows that the recommended dose and dosage regimen of new sustained‐release formulations of theophylline can be based upon single dose studies. In the population studied, repetitive doses of 450mg b.i.d. of Theo‐Dur® and Theotrim® maintain steady‐state concentrations of theophylline within the drug's therapeutic window.