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

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

Running the experiment 

Our step-by-step experiment guide is split into two sections (Drug Analysis and Dissolution) and you can download it below. You will need the following equipment and materials to run the experiment (n=6): 

 

MATERIALS

3F Powder
FFF01
7g
Buy 4, Save 28%
$139.99
-
+
FaSSGF Buffer Concentrate
FASGBUF
250g
Buy 10, Save 10%
$29.99
-
+
Two Stage FaSSIF Buffer Concentrate
2ST-FASBUF
286g
$29.99
-
+
FaSSIF Buffer Concentrate
FASBUF
250g
Buy 10, Save 10%
$29.99
-
+
GMF Syringe Filters 13mm
GMF13
72 pieces
Buy 8, Save 37%
$199.99
-
+

For n=6 vessels we recommend the following materials: 2 x FFF01, 1 x FASGBUF, 1 x 2ST-FASBUF, 1 x FASBUF and 1 x GMF-13.

3F Powder

X
X

3F Powder

3F Powder
FFF01
7g
3F Powder
FFF02
70g
In stock
$139.99
Buy 4, Save 28%
- +
In stock
$499.99
Buy 4, Save 20%
- +

Buffer Concentrates

X
X
X

Buffer Concentrates

FaSSGF Buffer Concentrate
FASGBUF
250g
Two Stage FaSSIF Buffer Concentrate
2ST-FASBUF
286g
FaSSIF Buffer Concentrate
FASBUF
250g
In stock
$29.99
Buy 10, Save 10%
- +
In stock
$29.99
- +
In stock
$29.99
Buy 10, Save 10%
- +

Syringe Filters

X

Syringe Filters

GMF Syringe Filters 13mm
GMF13
72 pieces
In stock
$199.99
Buy 8, Save 37%
- +

EXPERIMENT GUIDES

Two Stage Biorelevant Dissolution (Comparative)
ObjectiveSimulate how a drug behaves when FaSSGF converts into FaSSIF
FormulationImmediate Release Generic
MediaFaSSGF>FaSSIF
EquipmentUSP II
AnalysisHPLC
Two Stage Biorelevant Dissolution
ObjectiveSimulate how a drug behaves when FaSSGF converts into FaSSIF
FormulationImmediate Release NCE
MediaFaSSGF>FaSSIF
EquipmentUSP II
AnalysisHPLC

MEDIA PREP TOOL

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