A stable pharmaceutical composition comprising an acid...

A - Human Necessities – 61 – K

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A61K 9/50 (2006.01) A61K 31/4439 (2006.01)

Patent

CA 2558535

The present invention provides a stable pharmaceutical composition of an acid labile drug such as a pharmaceutically active substituted benzimidazole compound, comprising: a) an inner core coated with the acid labile drug; b) a first intermediate coating devoid of an alkaline stabilizing agent and the benzimidazole compound; c) a second intermediate coating comprising an alkaline stabilizing agent; and, d) an outer enteric layer. The present invention also provides a method of preparing the same.

La présente invention concerne une composition pharmaceutique stable d'un médicament labile en milieu acide, tel qu'un composé de benzimidazole substitué à activité pharmaceutique, qui comprend a) un noyau interne revêtu du médicament labile en milieu acide, b) un premier revêtement intermédiaire, exempt d'un agent stabilisant alcalin et du composé de benzimidazole, c) un second revêtement intermédiaire comprenant un agent stabilisant alcalin, ainsi que d) une couche externe gastro-résistante. La présente invention concerne également un procédé pour préparer ladite composition.

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