A process for the manufacture of pharmaceutical tablets...

Details A process for the manufacture of pharmaceutical tablets... A process for the manufacture of pharmaceutical tablets...

A - Human Necessities

61

K

A61K 31/4525 (2006.01) A61J 3/10 (2006.01) A61K 9/20 (2006.01)

Patent

CA 2439460

Pharmaceutical tablets containing crystalline paroxetine hydrochloride anhydrate are prepared using a process comprising an initial wet granulation process in which an aqueous granulation liquid is added to a mixture of said anhydrate an excipients under high-shear conditions and the thus obtained wet granules are dried using a fluidized bed technique to obtain a water activity within a specified range, after which the dried granules after addition of further adjuvants are compressed into stable tablets each having an identical composition.

L'invention porte sur des comprimés pharmaceutiques renfermant un hydrochlorure anhydre cristallin de paroxétine que l'on prépare en mettant en oeuvre un procédé comprenant une étape de granulation initiale par voie humide au cours de laquelle un liquide de granulation aqueux est ajouté au mélange contenant ledit anhydre et des excipients dans des conditions de fort cisaillement. La granulation est suivie de l'obtention de granules humides que l'on sèche grâce à la technique du lit fluidisé afin d'assurer une activité hydraulique dans une fourchette spécifiée. Finalement les granules séchés, une fois ajoutés d'autres adjuvants, sont comprimés sous forme de comprimés stables, chacun ayant une composition identique.

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