Patient Information Leaflets detail how medicines should be used
Oral drugs are generally taken with a glass of water or a meal
But food changes the composition of gastrointestinal juices a lot
This can have a big influence on how a drug behaves in the gastrointestinal tract and is absorbed by the body
Biorelevant testing enables you to simulate the complex conditions of the human gut in your laboratory
All you need to run biorelevant experiments is USP Apparatus 2 and HPLC: just switch dissolution media
This biorelevant medium simulates the fluid found in the small intestine before a meal. The small intestine is the site of absorption for oral dosage forms.
It is therefore very important to use biorelevant dissolution tests to get a more accurate idea of how much drug is likely to be absorbed in vivo.
This biorelevant medium replicates the fluid found in an empty stomach. It’s the first point of contact for immediate release oral dosage forms. Testing in it allows the user to get a clearer understanding of how much drug will go into solution before passing into the small intestine.
FeSSIF simulates small intestinal fluid after food. The small intestine is the main site of absorption of the drug so it is vital to understand how the presence of food may influence its behaviour.
By performing biorelevant dissolution tests the user can get a much better idea of possible food effects on the drug and therefore how much is likely to be absorbed in vivo.
FeSSGF represents gastric fluid after a meal. The fed state compared to the fasted state can massively change the behaviour of a drug.
It’s essential to test both generic and NCE test products to gain an understanding of the food effects on the dissolution of a drug.
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