Fedgas Tampon Concentrate

Fedgas Tampon Concentrate

FEDGAS simulates fed stomach fluids. You can leverage its power in your laboratory to distinguish significant formulation differences between your Test Product and Reference. This biorelevant dissolution medium contains 62.5 g of fat from a high-fat meal along with bile salts at physiological levels found in a fed stomach within 900 ml of solution. Testing in this medium is particularly beneficial for poorly water-soluble lipophilic drugs as it creates favorable physiological dissolution conditions for these drugs.

Three types of fed stomach media (at pH 6, pH 4.5, and pH 3) can be easily prepared using FEDGAS Gel and the appropriately diluted FEDGAS Buffer Concentrate. These three dissolution media reflect different states of gastric emptying:

• pH 6: Represents the early phase of gastric emptying.
• pH 4.5: Represents the mid-phase of gastric emptying.
• pH 3: Represents the late phase of gastric emptying.

Creating and comparing dissolution profiles in accurate biorelevant media helps reduce the risk of expensive and unsuccessful human bioequivalence studies due to formulation differences. Matching the dissolution profile of your Test Formulation to that of the Reference in FEDGAS maximizes the chance of achieving successful bioequivalence. In vitro biorelevant dissolution helps identify a Test formulation that matches the in vivo release rate of the Reference.