Friday, December 20, 2013
It shows the potential barriers for solid oral dosage forms. The barriers that the dosage form has toovercome before it can reach the systemic circulation involve dissolution or precipitation in the GI(gastrointestinal) lumen, instability in the GI tract,and permeation through the gut wall. And after that there is a first pass at the liver. If the compound itself is stable in the GI environment – in the lumen or in the gut wall – intestinal absorption is affected mainly by dissolution, solubility or permeation. The candidates for biowaiver based on BCS are compounds that fulfil five qualifications. They have to be immediate-release solid oral dosage forms. They cannot be drugs with a narrow therapeutic index. The formulation has to dissolve rapidly, and the compound itself has to have high solubility and high permeability.
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