Bioequivalence and Bioavailability Forum

Dear John,

Different regulatory guidelines have recommended different high-fat and high-calorie meal as a test meal for food-effect BA and fed BE studies. Which was sufficient food is given to allow potential perturbation of systemic BA of the drug from the drug product. The meal should contain approximately 30-40g of fat as this is likely to cause maximum perturbation to the release and absorption of the medicine. Similarly, protein and carbohydrate also effect the drug absorption of the drug product. Therefore it is recommended to take test medication after 30 minutes of the high-fat breakfast for uniform mixture of food particles in stomach for absorption. Different subject have different type of food intake habits. But the altimating goal was the mixture of high fat and calories of food in stomach environment which effecting the drug absorption. Similar effects was also reported in Invitro dissolution testing in different type of media e.g., 0.1N HCl (pH 2.2), pH 1.2 in SGFsp (simulated gastric fluid without pepsin), pH 6.8 in SIFsp (simulated Intestinal fluid without pancreatin, deionized water (pH approx. 5.5), fasted state simulated intestinal fluid (FaSSIF), and pH 6.5 and fed state simulated intestinal fluid (FeSSIF), pH 5.0. Hence, if subject will take food in sequential order or not, it will not effect the drug absorption in stomach as test drug will take after 30 minutes of high-fat breakfast.


Regards,
Susanta

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Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]