Method for producing a water-insoluble amorphous or...

A - Human Necessities – 61 – K

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Details

A61K 9/26 (2006.01) A61K 9/22 (2006.01) A61K 47/36 (2006.01)

Patent

CA 2372025

The invention relates to a method for producing pharmaceutical forms or preliminary stages thereof by means of extrusion. The pharmaceutical form has a matrix in which the active agent is contained essentially, and whose essential characteristics are determined by the extrusion process and which comprises a polysaccharide and/or a derivative thereof and/or a complex thereof and/or any mixture of the aforementioned substances with other substances and/or saccharides and/or derivatives thereof as an essential constituent, and at least one pharmaceutically active substance. The invention also relates to a pharmaceutical form which has a matrix in which the active agent is contained essentially, and whose essential characteristics are determined by the extrusion process, and which comprises a polysaccharide and/or a derivative thereof and/or a complex thereof and/or any mixture of the aforementioned substances with other substances and/or saccharides and/or derivatives thereof as an essential constituent, and at least one pharmaceutically active substance. Finally, the invention also relates to the use of said pharmaceutical form for producing granulates for tabletting and filling capsules, for further processing using injection moulding techniques and as an auxiliary material for direct tabletting and/or for producing monobloc pharmaceutical forms.

L'invention concerne un procédé de réalisation par extrusion de formes pharmaceutiques ou de ses précurseurs. La forme pharmaceutique présente une matrice contenant essentiellement le principe actif, les principales propriétés de ladite matrice étant obtenues par extrusion, et comprend un polysaccharide et/ou un de ses dérivés et/ou un de ses complexes et/ou un mélange quelconque de ces trois substances avec d'autres substances et/ou des saccharides et/ou de leurs dérivés comme composant principal de la matrice ainsi qu'au moins une substance à action pharmaceutique. L'invention concerne également une forme pharmaceutique comprenant une matrice contenant essentiellement le principe actif, les principales propriétés de ladite matrice étant obtenues par extrusion, et un polysaccharide et/ou un de ses dérivés et/ou un de ses complexes et/ou un mélange quelconque de ces trois substances avec d'autres substances et/ou des saccharides et/ou de leurs dérivés comme composant principal de la matrice ainsi qu'au moins une substance à action pharmaceutique. L'invention concerne également l'utilisation de la forme pharmaceutique pour l'obtention de granules destinées à la fabrication de comprimés ou au remplissage de gélules, pour la transformation par un procédé de moulage par injection, comme agent auxiliaire lors de la fabrication directe de comprimés, et/ou pour l'obtention de formes pharmaceutiques monoblocs.

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