Coated granules based on angiotensin-converting enzyme...

A - Human Necessities – 61 – K

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A61K 9/50 (2006.01) A61K 9/00 (2006.01) A61K 9/16 (2006.01) A61K 9/26 (2006.01) A61K 31/00 (2006.01) A61K 31/401 (2006.01) A61K 38/55 (2006.01)

Patent

CA 2446781

The invention concerns granules based on angiotensin converting enzyme inhibitor, its isomers or its pharmaceutically acceptable salts, characterised in that they are coated and that they contain ACE inhibitor monocrystals, one or several biding agents selected from the group comprising in particular cellulosic polymers, in particular ethylcellulose, hydroxypropylcellulose and hydroxypropylmethyl cellulose, acrylic polymers, polyvidones, polyvinylalcohols, and mixtures thereof, optionally a diluent selected from the group consisting in particular of cellulosic derivatives, starches, lactose, polyols, in particular mannitol, and an antistatic agent selected from the group comprising in particular colloidal silica, precipitated silica and talcum micronized or not. The invention also concerns the method for preparing said granules and orally dispersible tablets wherein they are used.

La présente invention concerne des granules à base d'inhibiteur de l'enzyme de conversion de l'angiotensine, de ses isomères ou de ses sels pharmaceutiquement acceptables (IEC) caractérisés par le fait qu'ils sont enrobés et qu'ils contiennent: des microcristaux d'IEC, un ou plusieurs agents liants choisis dans le groupe comprenant notamment les polymères cellulosiques, en particulier l'éthylcellulose, l'hydroxypropylcellulose et l'hydroxypropylmethylcellulose, les polymères acryliques, les povidones, les polyvinylalcools, et leurs mélanges, éventuellement un agent diluant choisi dans le groupe comprenant notamment les dérivés cellulosiques, les amidons, le lactose, les polyols, en particulier le mannitol, et un agent antistatique choisi dans le groupe comprenant notamment la silice colloïdale, la silice précipitée et le talc micronisé ou non; l'invention concerne également le procédé de préparation de ces granules et les comprimés orodispersibles dans lesquels ils sont mis en oeuvre.

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