Melt extrusion of salts of active ingredients

Details Melt extrusion of salts of active ingredients Melt extrusion of salts of active ingredients

A - Human Necessities

61

K

A61K 9/16 (2006.01) A61K 9/20 (2006.01)

Patent

CA 2474691

The invention relates to a method for producing active ingredient-containing granules or powders involving the following steps: a) melting a mixture consisting of a pharmaceutical active ingredient and of a (meth)acrylate copolymer, which is comprised of 40 to 75 wt. % of radically polymerized C1 to C4 alkyl esters of acrylic acid or of methacrylic acid and can be comprised of 25 to 60 wt. % (meth)acrylate monomers having an anionic group in the alkyl radial; b) extruding the mixture, and; c) comminuting the extrudate to form a granule or powder. The inventive method is characterized in that the active ingredient is the salt of an alkaline substance, and in that the pH value, which can be measured on the obtained powder or granule, is equal to or less than pH 7Ø The invention also relates to pharmaceutical dosage forms or precursors thereof, which can be produced using the inventive method.

L'invention concerne un procédé de fabrication de granulats ou poudres contenant des agents actifs, consistant a) à fondre un mélange d'un agent pharmaceutique et d'un copolymère de (méth)acrylate composé de 40 à 75 % en poids de C¿1?- à C¿4?-alkylesters de l'acide acrylique ou méthacrylique, polymérisés de façon radicalaire, et pouvant contenir de 25 à 60 % en poids de monomères de (méth)acrylate comportant un groupe anionique dans le reste alkyl, b) à extruder le mélange, et c) à broyer le produit d'extrusion sous forme de granulat ou de poudre. Le procédé selon l'invention est caractérisé en ce que l'agent actif est le sel d'une substance basique et en ce que le pH mesuré sur la poudre ou le granulat est 7,0 ou moins. L'invention concerne également des formes pharmaceutiques ou des précurseurs de celles-ci pouvant être obtenus au moyen du procédé selon l'invention.

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