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Comparative bio-availability of theophylline whole and halved sustained-release tablets.

Authors
  • Müller, F O
  • Hundt, H K
  • Luus, H G
  • van Dyk, M
  • Groenewoud, G
  • van der Meer, M J
  • Steinijans, V W
Type
Published Article
Journal
South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde
Publication Date
Aug 01, 1987
Volume
72
Issue
3
Pages
175–178
Identifiers
PMID: 3299763
Source
Medline
License
Unknown

Abstract

In a randomised, multiple-dose, cross-over study in 14 healthy volunteers, plasma theophylline concentrations were compared during a 12-hour dosing interval after repeated administration of theophylline (Euphyllin Retard; Byk Gulden) as whole and halved tablets. Bio-availability of theophylline from the halved tablets relative to the whole tablets was: 116% (100%, 134%) for the extent of absorption as judged by the area under the concentration time curve (AUC) and 115% (99%, 135%) for the rate of absorption as judged by maximum concentration (Cmax). The confidence levels for the 80-120% bio-equivalence range were 72% (AUC) and 76% (Cmax), those for the 80 and 125% range were 91% (AUC) and 91% (Cmax). The plateau times T75% Cmax, which characterise the sustained-released properties, were 8.5 +/- 2.9 hours (halved) and 8.3 +/- 2.5 hours (whole) during the 12-hour dosing interval. It is concluded that no clinically relevant deviations in steady-state plasma theophylline concentration and sustained-release properties are likely to result from breaking (halving) the film-coated tablets.

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