RIVM Report 329002001
Abstract niet beschikbaar
A literature study has been carried out on the release of active substance from monolithic enteric coated tablets and from disperse enteric coated forms (tablets or capsules) in the dog and the human. No important differences in gastro-intestinal processing of enteric coated products have been found between the dog and the human. The difference between both forms resides is the gastric processing. Monolithic forms are retained until the stomach is empty and are expelled by the housekeeper waves. The disperse forms, after desintegration, are treated as liquids and pass the pylorus gradually. This results in unpredictable gastric passage and effective plasma concentrations. The disperse forms release the active substance more uniformly and behave in this aspect more like slow or extended release products. Further research in this area should be directed on the discrepancy between release "in vitro" and "in vivo", and on the relation between higher pH values in the stomach (3-6) and premature release of the active substance.