Theophylline granule formulation prepared by the wet granulation method: comparison of in vitro dissolution profiles and estimation of in vivo plasma concentrations


KARASULU E. , APAYDIN Ş., İNCE İ. , TUĞLULAR I.

EUROPEAN JOURNAL OF DRUG METABOLISM AND PHARMACOKINETICS, vol.31, no.4, pp.291-298, 2006 (Journal Indexed in SCI) identifier identifier identifier

  • Publication Type: Article / Article
  • Volume: 31 Issue: 4
  • Publication Date: 2006
  • Doi Number: 10.1007/bf03190470
  • Title of Journal : EUROPEAN JOURNAL OF DRUG METABOLISM AND PHARMACOKINETICS
  • Page Numbers: pp.291-298

Abstract

The primary and secondary objectives of this study were to develop and evaluate the predictability of in vitro-in vivo correlation models for theophylline sustained release (SR) granules. Theophylline SR granules meeting the USP Drug Release Test criteria were prepared using ethyl cellulose (EC) and/or stearyl alcohol (SA) and the wet granulation method. In vitro dissolution studies of granule formulation were performed, and a commercial dosage form was prepared using USP XXIII apparatus II at pH 4.5. Differences and similarities between in vitro dissolution curves were compared using both model-dependent (t-test) and independent (f(1), f(2) test) statistical techniques, and it was shown that the three dissolution profiles i.e model-de pendent, model-independent, and methods based on ANOVA were very similar. The in vivo performance of the commercial dosage form was tested by oral route using male rabbits and in vitro-in vivo correlations were established.