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Biorelevant Solubility
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Use Biorelevant Mini Prep Kits with Biorelevant Solubility Filters to conduct standardized equilibrium solubility experiments rapidly and efficiently
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Prepare biorelevant medium freshly with single use vials of 3F Powder and mini bottles of buffer concentrate
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In vitro results help provide an understanding of how much drug dissolves in vivo within gastrointestinal fluids in both fasted (FaSSGF and FaSSIF) and fed (FeSSIF) states
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Results enable you to understand oral drug developability of a drug candidate
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Very small quantities (less than 1mg) of drug candidate required for each timepoint
Background
Establishing the biorelevant equilibrium solubility of a drug candidate can help you understand a drug's in vivo behaviour and absorption potential. Specifically, establishing a drug candidate's biorelevant solubility is crucial for understanding its potential to be delivered orally. Biorelevant equilibrium solubility is the first step towards guiding and selecting potential formulation strategies for a drug product.
Biorelevant equilibrium solubility test results can enable developers to:
• Estimate how much drug candidate is likely to dissolve within the gastrointestinal fluids
• Identify potential developability challenges such as poor absorption or reason for food effects
• Reveal potential oral developability
How to conduct a Biorelevant Equilibrium Solubility Test
1) Add drug candidate to biorelevant medium 2) Insert filter housing into vial 3) Incubate and collect samples. Analyse at 03h, 06h and 24h
*Determine the solubility of a drug candidate in the selected biorelevant medium by using Biorelevant Solubility Filters (available below)
*Dilute biorelevant solubility samples and analyse the amount of drug dissolved with HPLC (High-Performance Liquid Chromatography)
Getting started
We have produced step-by-step guides to help you set up the analytical method for your drug candidate and conduct the biorelevant equilibrium solubility test. You can download these here:
MATERIALS
Use the mini bottle of FaSSIF Buffer Concentrate with the matching vial of 3F Powder to make FaSSIF.
Use the mini bottle of FeSSIF Buffer Concentrate with the matching vial of 3F Powder to make FeSSIF.
Use the mini bottle of FaSSGF Buffer Concentrate with the matching vial of 3F Powder to make FaSSGF.
SELECT MEDIUM
Simulates Fasted State Intestinal Fluid
The kit can be stored at room temperature and has a shelf life of at least 12 months
Each kit contains 6 mini bottles of FaSSIF Buffer Concentrate and 6 vials of 3F Powder to make 6 x 100mL of medium
Makes 6 x 100mL portions of FaSSIF
Long shelf life (at least 12 months) and can be stored at room temperature
Biorelevant Solubility Filters come in packs of 50 pieces
Simulates Fed State Intestinal Fluid
The kit can be stored at room temperature and has a shelf life of at least 12 months
Each kit contains 6 mini bottles of FeSSIF Buffer Concentrate and 6 vials of 3F Powder to make 6 x 100mL of medium
Makes 6 x 100mL portions of FeSSIF
Long shelf life (at least 12 months) and can be stored at room temperature
Biorelevant Solubility Filters come in packs of 50 pieces
Simulates Fasted State Gastric Fluid
The kit can be stored at room temperature and has a shelf life of at least 12 months
Each kit contains 6 mini bottles of FaSSGF Buffer Concentrate and 6 vials of 3F Powder to make 6 x 100mL of medium
Makes 6 x 100mL portions of FaSSGF
Long shelf life (at least 12 months) and can be stored at room temperature
Biorelevant Solubility Filters come in packs of 50 pieces
