A process for the preparation of solid oral dosage forms...

Details A process for the preparation of solid oral dosage forms... A process for the preparation of solid oral dosage forms...

A - Human Necessities

61

K

A61K 31/66 (2006.01) A61K 9/16 (2006.01) A61K 9/20 (2006.01)

Patent

CA 2301195

The present invention relates to a process for preparing solid oral dosage forms, e.g. tablets, capsules, coated tablets/capsules, etc. comprising as active ingredient 4-amino-1-hydroxybutylidene-1,1-biphosphonic acid or oner of its pharmaceutical acceptable salts ("Alendronic acid"). It comprises the free acid or one of its pharmaceutically acceptable salts. The process is characterized by granulating pharmaceutical carriers with an aqueous solution of Alendronic acid which is solubilized with the aid of alkaline hydroxides or alkaline salts. The oral dosage forms obtained by this process are less irritating the digestive system than oral dosage forms obtained by conventional processes. The present invention also relates to tablets and to capsules prepared by said process.

Cette invention a trait à un procédé de préparation de formes posologiques solides à administration par voie orale, notamment des comprimés, des gélules, des comprimés/gélules enrobés, etc., renfermant comme ingrédient actif 4-amino-1-hydroxybutylidène-1,1-biphosphonique acide ou l'un de ses sels acceptables du point de vue pharmaceutique ("acide Alendronique"). Il comprend l'acide libre ou l'un de ses sels acceptables du point de vue pharmaceutique. Ce procédé se caractérise par la granulation de véhiculants pharmaceutiques avec une solution aqueuse d'acide Alendronique rendu soluble au moyen d'hydroxydes alcalins ou de sels alcalins. La forme posologique à administration par voie orale ainsi obtenue irrite moins le système digestif que les formes posologiques à administration par voie orale produites à l'aide des techniques classiques. Cette invention concerne également des comprimés et des gélules préparés grâce à ce procédé.

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