Solid pharmaceutical composition comprising irbesartan

Details Solid pharmaceutical composition comprising irbesartan Solid pharmaceutical composition comprising irbesartan

A - Human Necessities

61

K

A61K 9/20 (2006.01) A61K 9/16 (2006.01) A61K 31/415 (2006.01) A61P 9/12 (2006.01)

Patent

CA 2636663

The present invention concerns preferably surfactant-free solid pharmaceutical formulations comprising, as an active ingredient, at least one of irbesartan and pharmaceutically acceptable salts thereof, and at least one disintegrant. Preferably, the active ingredient comprises irbesartan hydrochloride. Also, the present invention is directed to a process for the manufacture of such formulations, including a wet granulation process (A) and a direct granulation process (B).

La présente invention concerne des formules pharmaceutiques solides préférentiellement sans tensioactifs et comprenant, en tant que principe actif, au moins l'un des membres du groupe constitué de l~irbesartan et de ses sels de qualité pharmaceutique, ainsi qu'au moins un agent désintégrant. De façon préférentielle, le principe actif comprend du chlorhydrate d'irbesartan. La présente invention a également pour objet un procédé de fabrication de telles formules, y compris un procédé de granulation humide (A) et un procédé de granulation directe (B).

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