Predicting Food Effects on Drug Release from Extended-Release Oral Dosage Forms Containing a Narrow Therapeutic Index Drug

Two schemes were designed to facilitate easy and efficient preparation of biorelevant "pH gradients" representing small intestinal conditions in the fasted and fed states. Results of release tests performed on theophylline MR preparations using these profiles correlated well with in vivo data (3). This indicates that the new schemes can be very useful in terms of performing effective and reliable in vitro tests to predict the in vivo behavior of MR dosage forms.