A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 9/16 (2006.01) A61J 3/00 (2006.01) A61K 9/54 (2006.01) A61K 31/708 (2006.01)
Patent
CA 2332922
A high drug load enteric coated pharmaceutical composition is provided which includes a core comprised of a medicament which is sensitive to a low pH environment of less than 3, such as dd1, which composition is preferably in the form of beadlets having an enteric coating formed of methacrylic acid copolymer, plasticizer and an additional coat comprising an anti-adherent. The so-called beadlets have excellent resistance to disintegration at pH less than 3 but have excellent drug release properties at pH greater than 4.5. A novel method of making said pharmaceutical composition is also disclosed.
L'invention concerne une composition pharmaceutique gastro-résistante à forte charge de médicament. Cette composition comprend un noyau constitué d'un médicament qui est sensible à un environnement à faible pH inférieur à 3, comme par exemple ddl, et est de préférence sous forme de granules présentant un revêtement gastro-résistant formé d'un copolymère acide méthacrylique, d'un ramollissant et d'un revêtement supplémentaire renfermant un anti-adhérent. Les granules font preuve d'une excellente résistance à la désintégration à un pH inférieur à 3 tout en faisant montre d'excellentes propriétés de libération de médicament à un pH supérieur à 4,5. L'invention concerne également un nouveau procédé de préparation de cette composition pharmaceutique.
Ullah Ismat
Wiley Gary J.
Bristol-Myers Squibb Company
Gowling Lafleur Henderson Llp
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