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Biorelevant Dissolution
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Reveal how an oral drug will be released from a formulation and dissolve in simulated gastrointestinal fluids
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Compare in vitro dissolution profiles of a Test Formulation against the Reference Formulation
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Streamline preclinical development by linking your oral drug's in vitro biorelevant solubility and dissolution to in vivo preclinical bioavailability
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Results help guide formulation development and optimisation
Biorelevant media simulate gastrointestinal fluids in both fasted and fed states. In vitro biorelevant dissolution experiments can predict how the drug product behaves in vivo after oral administration. These in vitro experiments, along with a drug’s biopharmaceutical data, help identify potential developability challenges related to absorption and food effects allowing you to select an appropriate oral formulation approach for your drug product. Biorelevant media also can be used for in vitro discriminatory dissolution studies to compare a Test Formulation against the Reference Formulation. Significant differences can be identified and formulations optimized before starting in vivo bioequivalence studies thereby reducing the risk of potential failures.
STEP 1: CHOOSE GUIDE
STEP 2: SELECT MEDIUM
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STEP 3: BUILD EXPERIMENT
FaSSIF= Fasted State Simulated Intestinal Fluid
i) To Make FaSSIF
Use 3F Powder + FaSSIF Buffer Concentrate to make FaSSIF in an instant
For 6L of FaSSIF: you will need 14g of 3F Powder + 250g of FaSSIF Buffer Concentrate
ii) Add Syringe Filters
For filtration of dissolution samples <5mL we recommend 13mm
For filtration of dissolution samples >5mL we recommend 25mm
72 pieces per pack
FeSSIF=Fed State Simulated Intestinal Fluid
i) To Make FeSSIF
Use 3F Powder + FeSSIF Buffer Concentrate to make FeSSIF in an instant
For 6L of FeSSIF: you will need 70g of 3F Powder + 500g of FeSSIF Buffer Concentrate
ii) Add Syringe Filters
For filtration of dissolution samples <5mL we recommend 13mm
For filtration of dissolution samples >5mL we recommend 25mm
72 pieces per pack
FaSSGF=Fasted State Simulated Gastric Fluid
i) To Make FaSSGF
Use 3F Powder + FaSSGF Buffer Concentrate to make FaSSGF in an instant
For 6L of FaSSGF: you will need 0.358g of 3F Powder + 250g of FaSSGF Buffer Concentrate
ii) Add Syringe Filters
For filtration of dissolution samples <5mL we recommend 13mm
For filtration of dissolution samples >5mL we recommend 25mm
72 pieces per pack
900mL of FEDGAS contains the 62.5g of fat present in a high-fat FDA meal along with the bile salts present in the fed stomach
i) To Make FEDGAS Early (pH6)
Use FEDGAS Gel + pH6 FEDGAS Buffer Concentrate to make FEDGAS Early (pH6) in an instant
For 6L: you will need 1kg of FEDGAS Gel + 250g of pH6 FEDGAS Buffer Concentrate
ii) Add Syringe Filters
For filtration of dissolution samples <5mL we recommend 13mm
For filtration of dissolution samples >5mL we recommend 25mm
72 pieces per pack
900mL of FEDGAS contains the 62.5g of fat present in a high-fat FDA meal along with the bile salts present in the fed stomach
i) To Make FEDGAS Mid (pH4.5)
Use FEDGAS Gel + pH4.5 FEDGAS Buffer Concentrate to make FEDGAS Mid (pH4.5) in an instant
For 6L: you will need 1kg of FEDGAS Gel + 250g of pH4.5 FEDGAS Buffer Concentrate
- For filtration of dissolution samples <5mL we recommend 13mm
- For filtration of dissolution samples >5mL we recommend 25mm
- 72 pieces per pack
ii) Add Syringe Filters
900mL of FEDGAS contains the 62.5g of fat present in a high-fat FDA meal along with the bile salts present in the fed stomach
i) To Make FEDGAS Late (pH3)
Use FEDGAS Gel + pH3 FEDGAS Buffer Concentrate to make FEDGAS Late (pH3) in an instant
For 6L: you will need 1kg of FEDGAS Gel + 250g of pH3 FEDGAS Buffer Concentrate
ii) Add Syringe Filters
For filtration of dissolution samples <5mL we recommend 13mm
For filtration of dissolution samples >5mL we recommend 25mm
72 pieces per pack
FaSSIF-V2= Fasted State Simualted Intestinal Fluid Version Two
i) To Make FaSSIF-V2
Use FaSSIF-V2 Powder with FaSSIF-V2 Buffer Concentrate to make the medium in an instant
For 6L: you will need 11g of FaSSIF-V2 Powder and 280g of FaSSIF-V2 Buffer Concentrate
ii) Add Syringe Filters
For filtration of dissolution samples <5mL we recommend 13mm
For filtration of dissolution samples >5mL we recommend 25mm
72 pieces per pack
FeSSIF-V2= Fed State Simulated Intestinal Fluid Version Two
i) To Make FeSSIF-V2
Use FeSSIF-V2 Powder with FeSSIF-V2 Buffer Concentrate to make the medium in an instant
For 6L: you will need 60g of FeSSIF-V2 Powder and 310g of FeSSIF-V2 Buffer Concentrate
ii) Add Syringe Filters
For filtration of dissolution samples <5mL we recommend 13mm
For filtration of dissolution samples >5mL we recommend 25mm
72 pieces per pack
FaSSCoF= Fasted Stae Simulated Colonic Fluid
i) To Make FaSSCoF
ii) Add Syringe Filters
For filtration of dissolution samples <5mL we recommend 13mm
For filtration of dissolution samples >5mL we recommend 25mm
72 pieces per pack
FeSSCoF= Fed State Simulated Colonic Fluid
i) To Make FeSSCoF
ii) Add Syringe Filters
For filtration of dissolution samples <5mL we recommend 13mm
For filtration of dissolution samples >5mL we recommend 25mm
72 pieces per pack
i) To Make Canine FaSSIF
ii) Add Syringe Filters
For filtration of dissolution samples <5mL we recommend 13mm
For filtration of dissolution samples >5mL we recommend 25mm
72 pieces per pack
i) To Make Canine FaSSGF pH6.5
ii) Add Syringe Filters
For filtration of dissolution samples <5mL we recommend 13mm
For filtration of dissolution samples >5mL we recommend 25mm
72 pieces per pack
i) To Make Canine FaSSGF pH1.5
ii) Add Syringe Filters
For filtration of dissolution samples <5mL we recommend 13mm
For filtration of dissolution samples >5mL we recommend 25mm
72 pieces per pack
