Development of In Vitro Dissolution Tests which Correlate Quantitatively with Dissolution Rate-Limited Drug Absorption in Man

The development of a single in vitro dissolution rate test is described, which correlates quantitatively with the gastrointestinal absorption, in man, of a test drug (aspirin) from three markedly different types of dosage forms. The in vitro conditions that yield such multiple correlations may be expected to be relatively similar to dissolution conditions found in vivo . It is suggested that the inclusion of an increasing number of variables (different drugs and different types of dosage forms) in future efforts to develop in vitro – in vivo correlations will permit further refinement of the in vitro test. This could eventually lead to a relatively generalized test procedure suitable for development and control purposes, and for inclusion in official compendia as a test of physiologic availability.