Christos Reppas, Napoleon-Nikolaos Vrettos, Jennifer Dressman, Cord J Andreas, Yoshihiro Miyaji, Jonathan Brown, Kelly Etherson, Sarah Hanley, Frank Karkossa, Eva Karlsson, Sandra Klein, Gerd-Michael Maier, Mark McAllister, Nena Mistry, Karin Rosenblatt, Kerstin Julia Schäfer, Kieran Lewis Smith, Irena Tomaszewska, James Williams, Fredrik Winge, Maria Vertzoni
During the OrBiTo project, our knowledge of the gastrointestinal environment has improved substantially and biorelevant media composition have been refined. The aim of this study was to propose optimized biorelevant testing conditions for modified release products, to evaluate the reproducibility of the optimized compendial apparatus III (USP apparatus III) and compendial apparatus IV (USP apparatus IV, open-loop mode) dissolution methods and to evaluate the usefulness of these methods to forecast the direction of food effects, if any, based on the results of two «ring» studies and by using two model modified release (MR) products, Ciproxin / Cipro XR and COREG CR...
August 31, 2020: European Journal of Pharmaceutics and Biopharmaceutics