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Biorelevant Experiment

Two Stage Biorelevant Dissolution

Simulate how a drug product behaves when it contacts the stomach fluid (FaSSGF) and then when it is converted into intestinal fluid (FaSSIF)
Particularly important for basic drugs with a higher solubility at acidic stomach pH compared to higher intestinal pH
Results will reveal the drug’s tendency to either supersaturate or precipitate
Results can help formulation development and optimisation

Background

After a patient has taken their drug with a glass of water:

1) Drug dissolution starts in gastric fluid 2) Bile juice converts transferred gastric fluid... 3) ... into small intestinal fluid. Drug dissolution continues

Biorelevant’s two stage dissolution experiment simulates this in vivo transfer process. It is based on the USP two stage dissolution method but uses in vitro biorelevant media that simulate in vivo fasted state stomach (FaSSGF) and intestinal fluids (FaSSIF):

1) Drug dissolution starts in FaSSGF 2) Adding 450mL of Two Stage FaSSIF to 450mL of FaSSGF converts it… 3) …into FaSSIF. Drug dissolution continues

Which type of drug and formulation is this experiment suitable for?

The two stage biorelevant experiment is particularly useful for poorly water-soluble basic drugs where absorption may be influenced by the gastrointestinal drug supersaturation or precipitation. It is suitable for both immediate release and enteric coated formulations.

Benefits

The two stage biorelevant experiment enables you to understand:

Gastrointestinal drug dissolution and stability before and after the transfer process
Potential gastrointestinal precipitation or supersaturation behaviour in simulated small intestinal fluid (FaSSIF)
How these properties can influence and improve the absorption of your drug

Getting started

We have produced step-by-step guides to help you conduct drug analysis and two stage biorelevant dissolution which you can download below. To run the experiments (n=6) you will need: