Improved process for producing a solid dispersion of an...

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 47/10 (2006.01) B29C 47/38 (2006.01) B29C 47/40 (2006.01) B29C 47/60 (2006.01) B29C 47/64 (2006.01) B29C 47/76 (2006.01) B29C 47/82 (2006.01)

Patent

CA 2644372

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 (R; A), (ii) at least one reverse-flight section (D), and (iii) a discharging section (E), wherein the processing elements defining the reverse-flight section (R; D) comprise at least one reverse-flight element (14) which is based on a screw-type element having a conveying direction being opposite to the general conveying direction of the extruder.

L'invention concerne un procédé de production d'une dispersion solide d'un principe 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 définissent (i) une partie d'alimentation et de transfert (R,A), (ii) au moins une partie à contrefilet (R, D) et (iii) une partie d'évacuation (E). Le ou les éléments de traitement définissant la partie à contrefilet (R, D) comprenne(nt) au moins un élément à contrefilet (14) fondé sur un élément de type écrou présentant une direction de transfert opposée à la direction de transfert générale de l'extrudeur.

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