Apparatus for simulating the effect of the living organism...

G - Physics – 01 – N

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G01N 33/15 (2006.01) G01N 13/00 (2006.01)

Patent

CA 2167196

An apparatus for simulating the effect of the liv- ing organism on the change in shape, the disintegra- tion 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 intesti- nal 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 de- vice (23) can be moved into and back out of the beaker (21) periodically and preferably vertically. The verti- cally 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 accor- dance with the periodic reciprocating movement of the agitating device (23).

Appareil de simulation de l'influence de l'organisme vivant sur les variations dimensionnelles d'une forme posologique pharmaceutique, sur sa tenue à la désagrégation et à la dissolution, et sur la libération d'un ingrédient acif par ladite forme posologique. L'appareil comporte un récipient creux (21) adapté pour contenir un milieu d'essai (P), par exemple un liquide gastrique ou intestinal de synthèse, et une forme posologique pharmaceutique (D), ainsi qu'un dispositif agitateur (23) suspendu à une potence (22) et destiné à agiter le milieu d'essai (P). Le dispositif agitateur (23) peut se déplacer périodiquement dans le sens vertical de manière à s'engager dans le récipient (21) ou à se retirer de celui-ci, et il comporte un embout en forme de piston (24) monté sur une tige de piston (25) et percé de trous permettant le passage du milieu d'essai (P). On peut modifier périodiquement la distance comprise entre l'embout de l'agitateur et le fond du récipient, en fonction du mouvement alternatif périodique dudit dispositif agitateur (23).

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