Biorelevant Dissolution Testing
Biorelevant dissolution testing can easily be carried out using standard USP dissolution apparatus with Biorelevant Media as the test media.
USP Dissolution Apparatus 2
Although different types of equipment can be used, USP Dissolution Apparatus 2 as described in USP Chapter <711> Dissolution is probably the most practical and easiest for biorelevant dissolution testing. Simply use the appropriate Biorelevant Media in the vessels. The USP Apparatus 2 is advantageous because temperature is constant, vessel dimensions are defined, rotation speed is controllable, disintegration can be visualized, sampling can be carried out manually and flexibly as well as semi-automated. All these benefits help you to achieve reliable results. This means the methods can be transferred more easily between labs and the interpretation of results by developers and assessors can be made with confidence.
In vitro biorelevant dissolution testing typically uses Biorelevant Media at a fixed volume, containing physiologically relevant components and at specific levels. This means the media have consistent physicochemical properties that resemble the in vivo physiological gastrointestinal fluids located within the various sections of the gut. Unlike QC testing, which is largely empirical, this makes media selection much easier as they are fixed.
Summary of what to do
When developing a generic drug, the goal is to match the dissolution profiles of your Test Product with the Reference Listed Drug in Biorelevant Media.
First of all, the dissolution profiles of your Test Product and the Reference should be obtained in the key Biorelevant Media.
Secondly, overlay and compare the dissolution profiles of the Test Product to corresponding profiles of the Reference Listed Drug. If the Test Product and Reference Drug dissolution profiles match in all media, it means you may have achieved your goal. If you’re unsure how to interpret your results, please contact the Biorelevant Help Desk. If the profiles match in all media, it is likely you have a Test product that releases at a similar rate to the Reference product in fluids that closely resemble physiological gut fluids.
Thirdly, you should be able to identify which medium or media shows promise if the release profiles do not match. The results should point the way to future dissolution optimization studies that may be needed to ensure the release profiles of the evolved Test Product match sufficiently to the Reference Product.