Biorelevant 101

How a medicine should be taken is usually explained in the patient information leaflet provided by the manufacturer. Whether a drug is taken before or after a meal can have a big impact on its absorption because food changes the properties of gastrointestinal fluids a lot. Gut fluids in both fasted and fed states are simulated by Biorelevant Media.

Why should I test in Biorelevant Media?

Simple in vitro tests can reveal the disintegration and dissolution process of a drug in fluids from different regions of the gut (stomach, small intestine) both before and after eating food. Dissolution tests in Biorelevant Media are particularly useful during drug development.

Biorelevant dissolution testing during the development of a bioequivalent drug product (e.g. a generic drug) can ensure that the release profile of a Test Formulation matches that of the Reference Listed Standard.

Biorelevant testing can also help identify formulations for water insoluble drugs with release profiles for optimal absorption.

The uses for Biorelevant Media are described in a variety of recent FDA and USP pharmacopeial guidelines for both immediate and modified release drug products. The latest USP chapter <1236 > also contains recommendations on biorelevant solubility tests.

How do I use these dissolution media?

The easiest and most reliable way to use Biorelevant Media is inside a USP Dissolution Apparatus 2. Dissolution can be carried out in a conventional way and samples analysed for drug content by HPLC. For immediate release drug product, we’ve developed a Biorelevant Dissolution Protocol which recommends the set up and sampling time points to be used.

Reproducible media can be produced by following our standardized Preparation Protocols which use the appropriate biorelevant surfactants and corresponding buffer concentrates.

Results obtained may not be like QC profiles, particularly for water insoluble drugs. If the drug is not completely released from the dosage form, this is not to be feared and is in fact a distinct benefit of testing in Biorelevant Media. You gain an insight into the actual dissolution process within gastrointestinal fluids which can reveal how the drug will behave in the body.