Learning Centre

Biorelevant Media 101
Tip Image
How matching dissolution profiles in Biorelevant Media will help identify which Test Formulation will be bioequivalent to the Reference
FaSSIF 101
Tip Image
Generating in vitro dissolution profiles of a Test Product and Reference in this Biorelevant Medium reveals the rates of drug release in vivo
FeSSIF 101
Tip Image
FeSSIF (Fed State Simulated Intestinal Fluid) is a biorelevant test medium that replicates biliary secretions present in small intestinal fluid after eating food
FaSSGF 101
Tip Image
Although drugs are not generally absorbed in the stomach, the interaction with stomach fluid can influence the solubility and dissolution of many drugs greatly and impact on the subsequent absorption
FEDGAS 101
Tip Image
FEDGAS dissolution media contain the full level of fat of an FDA meal along with carbohydrates, water soluble fibre and the low level of bile salts that is present in actual fed state stomach fluid due to intestinal reflux
Biorelevant Media: Discriminatory Dissolution Tools
Tip Image
Interaction of formulations with physiological components of Biorelevant Media mimic wetting and dissolution processes that occur in vivo
How to analyse your drug in Biorelevant Media
Tip Image
After drug separation, the medium (containing dissolved drug) is best analysed by HPLC. HPLC avoids potential interference of the media and can identify possible drug instability
How to carry out Biorelevant Dissolution
Tip Image
The test is based around USP Chapter <1092> 'The Dissolution Procedure' but it's specifically designed for BCS Class 2 drugs in any Biorelevant Media
The BCS (Biopharmaceutical Classification System)
Tip Image
Understanding a drug’s BCS class can help guide formulation development and assess development risk and difficulty