APPARATUS FOR SIMULATING THE EFFECT OF THE LIVING ORGANISM ON THE CHANGE IN SHAPE, THE DISINTEGRATION AND DISSOLUTION BEHAVIOUR AND THE ACTIVE-INGREDIENT RELEASE OF A PHARMACEUTICAL DOSAGE FORM

摘要

An apparatus for simulating the effect of the living organism on the change in shape, the disintegration and dissolution behaviour and the active-ingredient release of a pharmaceutical dosage form comprises a beaker-shaped container (21) for accommodating a test medium (P), for example a synthetic gastric or intestinal fluid, and a pharmaceutical dosage form (D), and an agitating device (23), suspended from a gallows-shaped boom (22), for the test medium (P). The agitating device (23) can be moved into and back out of the beaker (21) periodically and preferably vertically. The vertically reciprocating agitating device (23) comprises a piston-shaped head portion (24), arranged on a piston rod (25), which is provided with through-openings for the test medium (P) and the distance of which from the container floor can be altered periodically in accordance with the periodic reciprocating movement of the agitating device (23).