Budesonide pellets with a controlled release pattern and...

A - Human Necessities – 61 – K

Patent

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Details

A61K 31/58 (2006.01) A61K 9/50 (2006.01) A61K 9/54 (2006.01)

Patent

CA 2171852

The objects of the invention are budesonide pellets with a controlled release pattern containing, from the inside to the outside: a) neutral pellets; b) an active principle layer of micronised budesonide and one or more water-soluble auxiliaries; c) a lacquer coating (I) consisting of 80 to 97% lacquers insoluble in gastric juices but soluble in intestinal juices and 3 to 20% lacquers insoluble in both gastric and intestinal juices; and d) a lacquer coating (II) of 100% gastric and intestinal juices-insoluble lacquers. The invention also relates to a process for producing budesonide pellets with a controlled release pattern.

L'invention concerne des pellets de budésonide à libération contrôlée, qui se caractérisent en ce qu'ils contiennent en partant de l'intérieur vers l'extérieur: a) des pellets neutres, b) une couche de principe actif composée de budésonide micronisé et d'un ou de plusieurs additifs solubles dans l'eau, c) une couche d'enrobage (I) composée de 80 à 97 % de laques gastrorésistantes et entérosolubles et de 3 à 20 % de laques gastro- et entérorésistantes, et d) une couche d'enrobage (II) composée de 100 % de laques gastro- et entérorésistantes. L'invention concerne en outre un procédé de préparation de pellets de budésonide à libération contrôlée.

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