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PRODUCT DESCRIPTION
FEDGAS™ dissolution media simulate human stomach fluids in the fed state. 900mL of medium contains the 62.5g of fat and 62.5g of carbohydrate present in a partially digested, high-fat FDA meal. Three different pH values (6, 4.5 and 3) enable you to test various stages of stomach emptying.
Food-effect bioavailability studies (for new drugs) and fed bioequivalence studies (for generic drugs) are mandatory in most cases because food can have a significant impact on how the drug is absorbed. This is important because it can have a profound effect on drug efficacy and even safety in patients. It’s why dissolution tests in FEDGAS are so useful because they can help you understand how the drug is released in the stomach after eating a meal.
pH Flexibility
Three different pH’s enable you to test various stages of stomach emptying.
*FEDGAS pH6: simulates fluid when stomach is full (immediately after a meal)
*FEDGAS pH4.5: simulates fluid when stomach is 50% empty (approx. 1-2 hours after a meal)
*FEDGAS pH3: simulates fluid when stomach is 75% empty (approx. 3-6 hours after a meal)
Easy Preparation
FEDGAS dissolution media can be produced in seconds and used immediately: simply mix gel and buffer and you’re ready to go. We include a bottle of Buffer Concentrate (at the relevant pH) with each pack.
Usability
*Suitable for all types of drugs (acids, bases, neutral and salts)
*Compatible with USP Apparatus 2 (use 900mL of FEDGAS per dissolution vessel) and standard HPLC analytical equipment
*Easy to filter so avoids the need for time-consuming separation techniques. We recommend using these syringe filters that we have tested fully for compatibility with the media.
Case Studies
These case studies demonstrate how FEDGAS can be used to investigate the influence of food on drug performance.
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Preparation
FEDGAS™ Preparation Instructions
FEDGAS™ dissolution media simulate human stomach fluids in the fed state. You should use 900mL per dissolution vessel: this contains the amount of fat and carbohydrate present in a high-fat FDA meal. FEDGAS is available at 3 different pH values: 6, 4.5 and 3 (each sold separately).
Equipment
- Calibrated balance
- Suitable container
- Stirrer plate and PTFE magnet
Method
To make 900mL of FEDGAS pH6:
- Weigh 36.8g of FEDGAS Buffer Concentrate (pH6) into a suitable container
- Add 732.6g of purified water
- Add 153.0g of FEDGAS gel
- Stir until mixed thoroughly. The medium will be white like milk and is ready to use
To make 900mL of FEDGAS pH4.5:
- Weigh 36.8g of FEDGAS Buffer Concentrate (pH4.5) into a suitable container
- Add 730.8g of purified water
- Add 153.0g of FEDGAS gel
- Stir until mixed thoroughly. The medium will be white like milk and is ready to use
To make 900mL of FEDGAS pH3:
- Weigh 36.8g of FEDGAS Buffer Concentrate (pH3) into a suitable container
- Add 729.9g of purified water
- Add 153.0g of FEDGAS gel
- Stir until mixed thoroughly. The medium will be white like milk and is ready to use
Usage
- We recommend using FEDGAS dissolution medium at 37⁰C. It can be used for up to 24 hours at this temperature
- Store the FEDGAS gel pouch in the refrigerator and use within 7 days of opening
- Store the FEDGAS buffer bottle at room temperature
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TECHNICAL INFO
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SDS/COA
