Process for producing a solid dispersion of an active...

A - Human Necessities – 61 – K

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A61K 9/20 (2006.01) B29C 31/00 (2006.01) B29C 47/00 (2006.01) B29C 47/60 (2006.01) B29C 47/10 (2006.01) B29C 47/38 (2006.01) B29C 47/40 (2006.01) B29C 47/64 (2006.01) B29C 47/76 (2006.01) B29C 47/82 (2006.01)

Patent

CA 2644035

A process for producing a solid dispersion of an active ingredient which comprises feeding the active ingredient and a matrix-forming agent to an extruder and forming a uniform extrudate, wherein the extruder comprises at least two rotating shafts (2), each of the shafts (2) carrying a plurality of processing elements disposed axially one behind the other, the processing elements defining (i) a feeding and conveying section (A), (ii) at least one mixing section (B), and (iii) a discharging section (E), wherein the processing element(s) defining the mixing section (B) comprise(s) a mixing element (11, 12, 13) that is derived from a screw type element (figure 2).

L'invention concerne un procédé de production d'une dispersion solide d'un principe actif actif. Ce procédé consiste à envoyer le principe actif et un agent de formation de matrice dans un extrudeur, puis à former un extrudat uniforme. L'extrudeur comprend au moins deux arbres rotatifs (2), chaque arbre (2) portant une pluralité d'éléments de traitement montés axialement les uns derrière les autres. Les éléments de traitement définisssent (i) une partie d'alimentation et de transfert (A), (ii) au moins une partie de mélange (B) et (iii) une partie d'évacuation (E). Le ou les éléments de traitement définissant la partie de mélange B comprenne(nt) un élément de mélange (11, 12, 13) dérivé d'un élément de type écrou (figure 2).

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