A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 9/26 (2006.01) A61K 9/00 (2006.01) A61K 9/16 (2006.01) A61K 31/4439 (2006.01) A61K 33/06 (2006.01) A61K 33/08 (2006.01) A61K 33/10 (2006.01) A61K 45/06 (2006.01) A61P 1/04 (2006.01) A61K 9/20 (2006.01) A61K 9/50 (2006.01)
Patent
CA 2453290
The present invention deals with a multiparticulate tablet, which disintegrates in the mouth containing: i) a proton pump inhibiting agent, in particular of the benzimidazole type, in the form of enteric coated microgranules, which enteric coated granules are overcoated with at least one barrier coating, such as for instance a methacrylic copolymer-based protective film; ii) at least one antacid in the form of granules, for instance based on CaCO3 and/or Mg(OH)2 and/or Al(OH)3; and, iii) a mixture of excipients comprising at least one disintegrating agent, one diluent agent, a lubricant, and optionally a swelling agent, a permeabilising agent, sweeteners, flavourings and colours. Furthermore, the present invention is directed to processes for the manufacture of the tablet and its use in the treatment of gastrointestinal disorders.
L'invention concerne un comprimé multiparticulaire, orodispersible, qui comprend: i) un inhibiteur de la pompe à proton, en particulier de type benzimidazole, sous forme de micro-granulés entériques enrobés, ceux-ci étant enrobés d'au moins une couche d'enrobage, telle que par exemple un film protecteur à base de copolymère méthacrylique; ii) au moins un antiacide sous forme de granulés, par exemple à base de CaCO¿3? et/ou de Mg(OH)¿2? et/ou de Al(OH)¿3?; et, iii) un mélange d'excipients comprenant au moins un délitant, un diluant, un lubrifiant, et éventuellement un agent de gonflement, un agent perméabilisant, des édulcorants, des aromatisants et des colorants. En outre, l'invention concerne des procédés de fabrication du comprimé et son utilisation dans le traitement de troubles gastro-intestinaux.
Criere Bruno
Nouri Nourredine
Pilbrant Ake
Suplie Pascal
Zuccarelli Jean-Marc
Astrazeneca Ab
Fetherstonhaugh & Co.
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