Pharmaceutical composition comprising ezetimibe and simvastatin

Details Pharmaceutical composition comprising ezetimibe and simvastatin Pharmaceutical composition comprising ezetimibe and simvastatin

A - Human Necessities

61

K

A61K 9/20 (2006.01)

Patent

CA 2745248

The present invention belongs to the field of pharmaceutical industry and relates to a process for preparing dosage forms containing simvastatin and ezetimibe, comprising the steps of providing a first composition containing simvastatin, providing a second composition containing ezetimibe, and forming a dosage form comprising at least two separate compartments, wherein one compartment is formed using either the first or the second composition and another compartment is formed using the other composition. The present invention also relates to a process for preparing dosage forms containing simvastatin and ezetimibe, wherein the process involves a direct compression step. Furthermore, the present invention belongs to a dosage form obtained by this process, comprising at least two separate compartments, wherein one compartment contains simvastatin and one compartment contains ezetimibe. Finally, the present invention relates to a combination dosage form comprising a combination of simvastatin and ezetimibe present in two separate compartments of the dosage form.

La présente invention appartient au domaine de lindustrie pharmaceutique et concerne un procédé de préparation de formes galéniques contenant de la simvastatine et de lézétimibe, le procédé comprenant les étapes consistant à fournir une première composition contenant de la simvastatine, obtenir une seconde composition contenant de lézétimibe et former une forme galénique comprenant au moins deux compartiments séparés, un compartiment étant formé au moyen de la première ou de la seconde composition et lautre compartiment étant formé au moyen de lautre composition. La présente invention concerne également un procédé de préparation de formes galéniques contenant de la simvastatine et de lézétimibe, le procédé impliquant une étape de compression directe. En outre, la présente invention concerne une forme galénique obtenue grâce à ce procédé, la forme galénique comportant au moins deux compartiments séparés, un compartiment contenant de la simvastatine et un compartiment contenant de lézétimibe. Finalement, la présente invention concerne une forme galénique combinée contenant en combinaison de la simvastatine et de lézétimibe présents dans deux compartiments séparés de la forme galénique.

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