Enteric soft gelatin capsule containing esomeprazole and...

A - Human Necessities – 61 – K

Patent

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Details

A61K 9/48 (2006.01) A61K 31/4439 (2006.01)

Patent

CA 2540105

The present invention relates to an improved pharmaceutical composition, in the form of a soft gel capsule resistant to digestive juice. The composition of the present invention is made up of gelatin and an enteric polymer in the form of free acid or its salt, containing used in the treatment of duodenal ulcers, solublised and / or suspended in a liquid or semisolid medium, comprising the enantiomers of omeprazole such as esomeprazole or rabeprazole or other enantiomers of omeprazole or its salts or derivatives or their mixtures, a hydrophobic carrier, an alkaline inert reacting material and a surface active agent and / or a solublising agent wherein the resulting capsules being insoluble in aqueous medium up to a pH of 5.5 but quickly dissolving above pH of 6Ø The present invention also relates to a process of preparing the above said pharmaceutical composition.

L'invention concerne une composition pharmaceutique améliorée, se présentant sous la forme d'une capsule de gel résistant au suc digestif. La composition de l'invention est fabriquée dans de la gélatine et contient un polymère entérique sous forme d'acide libre ou son sel, et elle est utilisée, dans le traitement d'ulcères du duodénum, sous forme soluble et/ou en suspension dans un milieu liquide ou semi-liquide. Ledit milieu comprend des énantiomères d'oméprazole tel que l'ésoméprazole ou le rabéprazole ou tout autre énantiomère d'oméprazole ou de ses sels ou ses dérivés ou leurs mélanges, un support hydrophobe, une matière alcaline, inerte, réactive et un agent de surface active et/ou un agent solubilisant. Les capsules ainsi obtenues sont insolubles dans un milieu aqueux présentant un pH supérieur à 5,5, mais elles se dissolvent rapidement dans un pH supérieur à 6,0. L'invention concerne également un procédé pour préparer ladite composition.

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