ABSTRACT

Dimitris G. Fatouros and Anette Müllertz Department of Pharmaceutics and Analytical Chemistry, The Danish University of

Pharmaceutical Sciences, Copenhagen, Denmark

INTRODUCTION

The development of effective oral dosage forms for hydrophobic new chemical entities (NCE) continues to be a pressing problem for the pharmaceutical industry. Many of these poorly water-soluble NCEs readily permeate biological membranes thus making their maximum solubility and/or dissolution rate in the gastrointestinal tract (GIT) rate-limiting steps to their absorption. These biopharmaceutical properties describe Biopharmaceutics Classification System (BCS) Type II compounds, which usually present with both low and variable bioavailability that is frequently influenced by the dietary status of the patient (fed vs. fasted).