Dissolution Media Simulating Fasted and Fed States

Abstract

When dissolution testing is used to forecast the in vivo performance of a drug, it is critical that the in vitro test mimic the conditions in vivo as closely as possible. A team of researchers, led by Dr. Jennifer Dressman of the J. W. Goethe University,Germany,has developed biorelevant gastrointestinal media that simulate the fasted and fed states. These media have been used to examine the solubility and dissolution characteristics of several classes of drugs including poorly soluble weak bases and lipophilic drugs to assist in predicting in vivo absorption behavior (1). Biorelevant in vitro dissolution testing is useful for qualitative forecasting of formulation and food effects on the dissolution and availability of orally administered drugs. It has been observed that biorelevant media can provide a more accurate simulation of pharmacokinetic profiles than simulated gastric fluid or simulated intestinal fluid. The use of biorelevant media can have a great impact on the pharmacokinetic studies performed to optimize dosing conditions and product formulation. In addition, biorelevant dissolution testing could be used to assess bioequivalence of post-approval formulation changes in certain kinds of drugs (2–5). The formulation and preparation instructions for the biorelevant media developed by Dr. Dressman’s group are detailed below.