Method for producing granulated preparation

A - Human Necessities – 61 – K

Patent

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Details

A61K 47/02 (2006.01) A61K 9/14 (2006.01) A61K 9/32 (2006.01) A61K 9/50 (2006.01) A61K 31/4433 (2006.01) A61K 31/4439 (2006.01) A61K 47/26 (2006.01) A61K 47/32 (2006.01) A61K 47/36 (2006.01) A61K 47/38 (2006.01) A61P 1/04 (2006.01) A61P 43/00 (2006.01)

Patent

CA 2704826

It has been desired to provide a method for producing a granulated preparation capable of maintaining a stability of a chemically unstable substance in a neutral or acidic region for a long period of time with a simple and safe method in a preparation procedure, and a tablet produced by using the method. The invention provides a granulation method in which an unstable substance is successively subjected to aqueous stabilization treatment and granulation procedure. Further, it became possible to provide a tablet which is absorbed in the intestine without losing the potency in a gastric region by forming an intermediate layer on a surface of the thus obtained granule and subsequently subjecting the granule to enteric coating.

La présente invention concerne la production d'une substance granulée capable de maintenir la stabilité d'une substance chimiquement instable dans une zone de pH neutre ou acide pendant une longue période grâce à un procédé de préparation simple et sûr. L'invention concerne également un comprimé obtenu grâce audit procédé. L'invention concerne, plus précisément, un procédé de granulation dans lequel une substance instable est successivement soumise à un traitement de stabilisation en phase aqueuse et à une procédure de granulation. En outre, il devient ainsi possible de fournir un comprimé qui est absorbé dans l'intestin sans perdre de son efficacité au niveau de la région gastrique grâce à la formation d'une couche intermédiaire à la surface du granulé ainsi obtenu, l'étape de formation étant suivie de la mise en place d'un enrobage entérique sur le granulé.

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