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Abstract
The prolonged release of drug from hydrophilic matrix tablets can be greatly affected by administration in connection with the intake of food. Changes of the tablet erosion are one of the main components of this effect. The aim of the present study was to identify the postprandial factors responsible for changes in tablet erosion and to develop predictive in vitro tests. Two formulations, one sensitive and the other robust to prandial effects in vivo, were investigated in vitro (a) in a complex physiological media simulating fasting and fed conditions; (b) according to a factorial experimental design that included agitation and pH concentrations of salt, surface-active agent, and nonionic solute as factors; and (c) at varying agitation intensities in three different sets of dissolution apparatus. Of the studied factors, only increased agitation enhanced the erosion of tablets in accordance with the in vivo effects of a meal. The other factors retarded erosion or had only minor effects. The hydrodynamic mechanical stress was thus considered to be the main factor responsible for postprandial effects on tablet erosion. The influence of changes in agitation and the opportunity to discriminate between sensitive and robust formulations differed among the three sets of dissolution apparatus. The modified USP II apparatus, operated at speeds of 50 and 100 rpm, is proposed as a discriminatory test.