Process for preparing granular compositions

A - Human Necessities – 61 – K

Patent

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Details

A61K 9/16 (2006.01) A61J 3/02 (2006.01) A61K 31/192 (2006.01) B01J 2/20 (2006.01) B30B 11/22 (2006.01) B30B 11/24 (2006.01)

Patent

CA 2449356

A process for the preparation of a granular composition comprising solidified melt granules comprising a non-steroidal anti-inflammatory drug (NSAID) as a continuous phase, which process comprising the steps of: (a) melt-extruding the NSAID, optionally with excipients; (b) forming a homogeneous extrudate; (c) cooling the extrudate; and (d) comminuting the cooled extrudate to form granules; characterised in that in the step (a) the NSAID is fully melted and that in step (b) the extrudate is formed into two or more ribbons having a depth of 10 mm or less and which solidify in 5 minutes or less.

L'invention concerne un procédé de fabrication d'une composition granulaire contenant des granulés de fusion solidifiés, composés d'un anti-inflammatoire non stéroïdien en tant que phase continue. Le procédé selon l'invention consiste (a) à extruder par fusion l'anti-inflammatoire non stéroïdien, éventuellement à l'aide d'excipients ; (b) à former un extrudat homogène ; (c) à refroidir l'extrudat ; et (d), à broyer l'extrudat refroidi afin de former des granulés. Ledit procédé est caractérisé en ce que l'anti-inflammatoire non stéroïdien est entièrement fondu à l'étape (a), et en ce que l'extrudat est formé en tant qu'au moins deux rubans à l'étape (b), lesdits rubans présentant une profondeur de 10 mm ou moins et se solidifiant en 5 minutes ou moins.

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