Home
Gastro-Duodenal Media
-
Biorelevant dissolution media simulating duodenal fluids after a glass of water
-
Reduce the risk of bioequivalence (BE) failures for water insoluble drugs
-
Designed for use in standard USP Dissolution 1 and 2 apparatus
-
Each pack makes 6L of dissolution medium
FASINT, FEDINT and FASGAS dissolution media simulate human gastro-duodenal fluids. They have superior discriminatory power of neutral BCS Class 2 drugs that have little to no food effect. Drug analysis must be carried out using HPLC. These media provide a useful balance between:
-physiological relevance
-discriminatory power
-practical laboratory use
They are particularly helpful when evaluating drug products where formulation differences may influence in vivo absorption.
FASINT
FASINT is a biorelevant dissolution medium designed to simulate early post-dose fasted intestinal conditions, representing duodenal fluid following administration with a glass of water.
Key benefits:
• Represents early fasted intestinal exposure following oral dosing with water
• Supports formulation optimisation for fasted state administration
• Useful for comparative dissolution of Test vs Reference products
• Helps reduce risk of fasted state bioequivalence (BE) failure for poorly water-soluble drugs
• Particularly suitable for neutral BCS Class II drugs with minimal food effect
• Reveals formulation differences not detected in conventional QC media
FEDINT
FEDINT is a biorelevant dissolution medium designed to simulate postprandial intestinal conditions, representing duodenal fluid following intake of a meal administered under fed-condition bioequivalence (BE) study conditions. It enables evaluation of how formulated drug products behave under fed state conditions where food-driven solubilization influences dissolution behaviour.
Key benefits:
• Represents fed intestinal exposure following intake of a standard fed-condition BE meal
• Supports understanding of formulation behaviour in fed-state BE studies
• Useful for comparative dissolution of Test vs Reference products
• Particularly suitable for poorly soluble drugs exhibiting food effects due to increased solubilisation capacity associated with food components
• Helps identify formulation-dependent differences driven by food and bile secretions
FASGAS
FASGAS is a biorelevant dissolution medium designed to simulate early post-dose fasted gastric conditions, representing gastric fluid following administration with a glass of water. It enables evaluation of how formulated drug products behave in the gastric environment during fasted state bioequivalence (BE) studies, particularly where dissolution behaviour is influenced by gastric pH conditions.
Key benefits
• Represents early fasted gastric exposure following oral dosing with water
• Supports understanding of formulation behaviour in fasted-state BE studies
• Useful for comparative dissolution of Test vs Reference products
• Particularly suitable for pH-sensitive drugs and supersaturating formulations
• Helps identify gastric-stage risks that may influence downstream absorption
