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Abstract

An apparatus for simulating the effect of a living organism on the change in shape, the disintegration and dissolution behaviour and the active-ingredient release of a pharmaceutical dosage form, including a beaker-shaped container for accommodating a test medium and the pharmaceutical dosage form and an agitating device for agitating the test medium, which agitating device can be moved periodically in a reciprocating movement into and back out of the container, wherein the agitating device includes a piston-shaped head portion arranged on a piston rod, which head portion is provided with through-openings for the test medium and the distance of the piston-shaped head portion from the container floor can be altered periodically in accordance with the periodic reciprocating movement of the agitating device, wherein, the piston rod is suspended from a gallows-shaped boom or the piston rod passes through a bore in the gallows-shaped boom in such a manner that downward movement of the piston-shaped head portion arranged on the piston rod is caused by gravity alone and wherein there is arranged in the container an intermediate base supported on the container floor, the base being provided with through-openings for the test medium and serving as a support for the dosage form, wherein the distance between the intermediate base and the container floor is adjustable by a device for adjusting the distance between the base and the floor.

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First Claim