Measuring and testing – Instrument mechanism or transmission – Rate of change
Patent
1996-02-06
1998-10-27
Williams, Hezron E.
Measuring and testing
Instrument mechanism or transmission
Rate of change
738656, 366142, G01N 3315
Patent
active
058279849
DESCRIPTION:
BRIEF SUMMARY
CROSS-REFERENCE TO RELATED APPLICATIONS
This is a 371 of PCT/EP 94/02485, filed Jul. 28, 1994.
BACKGROUND OF THE INVENTION
The invention relates to 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 according to the preamble of patent claim 1.
Pharmaceutical dosage forms must be adapted to the physiological conditions prevailing on or in the living organism, for example on the skin or in the gastrointestinal tract, in order to be as well suited as possible to the living organism, for example as regards their rate of dissolution and the release of active ingredients. For that purpose, recommended analysis procedures that reproduce as closely as possible the real physiological conditions of the living organism and are intended to allow comparison of the different dosage forms have often been laid down by government bodies. Various analysis apparatuses that take those procedures into account and that are intended to simulate and reproduce the physiological, i.e. including the physico-chemical, conditions of, for example, the gastrointestinal tract are known. For the determination of the disintegration and dissolution behaviour of solid oral dosage forms, for example tablets, dragees and capsules, in the gastrointestinal tract, analysis apparatuses have been developed that, especially, permit analyses in accordance with the "United States Pharmacopoeia XXII, 1990" (USP).
One such analysis apparatus that conforms to the USP (USP XXII, 1990, pages 1577-1583) is based on the wire-basket method proposed in the USP. The test arrangement comprises a cylindrical vessel of transparent material, for example glass or plexiglass, having a hemispherical base. Arranged inside the vessel is a wire basket secured to a shaft rotatable by a motor. The shaft and the wire basket secured thereto are vertically displaceable, so that the distance between the base of the wire basket and the floor of the vessel is adjustable. In order to analyse the disintegration and dissolution behaviour of an oral dosage form, the latter is arranged inside the cage and is lowered together with the cage into the vessel which contains, for example, synthetic gastric or intestinal fluid. The shaft and with it the cage is then rotated by the motor at the speed specified in the test procedure. The rotation of the cage together with the dosage form contained therein is intended to simulate the shearing forces of the fluid acting on the dosage form in the gastrointestinal tract. The gastric or intestinal fluid in the vessel can be pumped round continuously in order to allow the active-ingredient concentration to be determined continuously using an associated analysis unit, for example a spectroscopic analysis unit. In that manner the release of active ingredient by the dosage form in the gastric or intestinal fluid over time can be determined. Because the vessel is transparent, the disintegration of the solid dosage form can be determined visually in accordance with certain predetermined criteria. In particular, the condition of the dosage form is visually assessed periodically over relatively long periods of time.
A further known analysis apparatus is based on the paddle method proposed in the USP (USP XXII, 1990, pages 1577-1583). As in the case of the apparatus described hereinbefore, that analysis apparatus comprises a cylindrical vessel of preferably transparent material and having a hemispherical base. A motor-driven shaft is provided at one end with paddles that are immersed into the gastric or intestinal fluid in the vessel. The shaft is again vertically displaceable to enable the distance between the paddles and the floor of the vessel to be adjusted in accordance with the specifications. In order to be tested, the dosage form is introduced into the fluid. If necessary, the solid dosage form can be weighted with a piece of inert material to prevent it from floating up. The rotation of the paddles a
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patent: 2530065 (1950-11-01), King
patent: 3618395 (1971-11-01), Melliger
patent: 3791221 (1974-02-01), Kirschner et al.
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patent: 4855821 (1989-08-01), Swon et al.
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Aoki et al., International Journal of Pharmaceutics, vol. 95, pp. 67-75 (1993).
SOTAX DT3 tablet-disintegration testing apparatus brochure.
USP XXII, pp. 1577-1583 (1990).
Bosshard Christian
Sinnreich Joel
Ashraf Nashmiya
Ciba Geigy Corporation
Mathias Marla J.
Williams Hezron E.
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