Pharmaceutical composition comprising a hot-melt granulated...

A - Human Necessities – 61 – K

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A61K 47/12 (2006.01) A61K 9/20 (2006.01) A61K 9/48 (2006.01) A61K 31/663 (2006.01) A61P 19/08 (2006.01) A61P 19/10 (2006.01) B01J 2/00 (2006.01)

Patent

CA 2671728

The present invention relates to a lubricant granulate prepared using a hot melt granulation process, or thermal-heat process. The lubricant granulate is useful in facilitating the use of higher concentrations of lubricant than typically possible in pharmaceutical compositions. Also provided are pharmaceutical compositions comprising the lubricant granulate. Such pharmaceutical compositions can contain bisphosphonic acid as the active ingredient and can be suitable for oral administration. The present invention also provides a hot melt process for preparing the lubricant granulate for subsequent use in pharmaceutical compositions.

La présente invention concerne un granulé lubrifiant préparé à l'aide d'un procédé de granulation par fusion ou d'un traitement thermique. Le granulé lubrifiant est employé pour faciliter l'utilisation de concentrations de lubrifiant plus grandes que celles utilisées généralement dans des compositions pharmaceutiques. L'invention concerne également des compositions pharmaceutiques comprenant le granulé lubrifiant. Ces compositions pharmaceutiques peuvent contenir de l'acide bisphosphonique comme principe actif et convenir à une administration orale. La présente invention concerne également un procédé de thermofusion destiné à la préparation du granulé lubrifiant utilisé par la suite dans des compositions pharmaceutiques.

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