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

Two stage biorelevant dissolution is also referred to as a “biorelevant transfer test”. The method is designed to test how a drug product behaves when in contact with simulated gastric fluid (FaSSGF) which is subsequently converted into simulated intestinal fluid (FaSSIF). This in vitro experiment simulates the in vivo process when fasted stomach fluid containing a drug product is converted to fasted intestinal fluid. For immediate release formulations of basic drug, the two stage biorelevant dissolution test is conducted in USP 2 apparatus.

The test is mainly used during the development of drug products of water insoluble bases where solubility of the drug is higher in the gastric fluid than the intestinal fluid. The results reveal insights into precipitation or supersaturation as the pH is shifted from stomach to intestinal pH. It is a similar principle to the USP two-tier dissolution test described in USP Chapter <711> (Method A Procedure). However, the significant difference is that the acid and buffer stages used are biorelevant. Two media need to be prepared: FaSSGF and Two Stage FaSSIF (in effect 'concentrated' FaSSIF). Dissolution is first carried out in FaSSGF and continues as Two Stage FaSSIF is then added to make FaSSIF.

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

PC
loading...

How many litres do you require?