Biorelevant Dissolution Test Method
We have developed a biorelevant dissolution test method that is very easy to follow and uses standardized USP 1 or 2 apparatus. It can be used for most immediate release oral dosage forms, particularly BCS Class 2 and BCS Class 4 drugs. The principles of the test are based around USP Chapter <1092> 'The Dissolution Procedure' but it's specifically designed for poorly water soluble drugs in biorelevant media. If you have an existing QC HPLC method, this can typically be used or adapted to analyse the drug.
The test protocol is in two sections. In the first section, we recommend conducting a few preliminary assessment experiments before dissolution testing and analysis of your dosage form:
*Analysis of your dosage form
*Check HPLC sample stability
*Assess filter adsorption
Once these pre-experiments have been completed, you can start your dissolution runs which comprise section 2 of the protocol.
Our dissolution protocol utilizes some of the parameters of the existing dissolution method you may have such as the use of a sinker and mixing speed. However, it also contains useful guidance on media preparation, recommended volumes, sampling times as well as tips to minimize experimental variability. This should help you achieve highly reproducible results for your drug tested in our biorelevant media.
If you have any questions or would like a copy of the protocols for using our FaSSIF/FeSSIF/FaSSGF or FEDGAS dissolution media, please contact our Technical Support team.