A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 9/16 (2006.01) A61K 31/485 (2006.01) A61K 9/50 (2006.01)
Patent
CA 2608361
Described is a pellet composition comprising a core element comprising morphine sulfate, a filler and a binder, wherein the morphine sulfate, calculated as the anhydrous form, comprises about 50 wt% to about 85 wt% of the total weight of the core element; and a coating disposed on at least a portion of the core element, the coating comprising an insoluble matrix polymer which is insoluble at pH 1 to 7.5; an enteric polymer which is insoluble at pH 1 to 4 and soluble at pH 6 to 7.5; and an acid soluble polymer which is soluble at a pH of 1 to 4, wherein the ratio of the acid soluble polymer to the enteric polymer is 1.45:1 to 2.5:1 on a weight basis. Also described are dosage forms comprising the disclosed pellets.
L'invention concerne une composition en grains, qui comprend un élément central contenant du sulfate de morphine, une matière de charge et un liant. Le sulfate de morphine, calculé en tant que forme anhydre, comprend environ 50 à 85 % en poids du poids total de l'élément central, et un enrobage disposé sur au moins une partie de l'élément central et comprenant une matrice insoluble à un pH de 6 à 7,5; un polymère entérique insoluble à un pH de 1 à 4 et soluble à un pH de 6 à 7,5; et un polymère soluble dans l'acide à un pH de 1 à 4, le rapport du polymère soluble dans l'acide au polymère entérique étant de 1,45:1 à 2,5:1, sur la base du poids. L'invention concerne également des formes posologiques comprenant les grains de l'invention.
Liang Alfred C.
Alpharma Inc.
Ogilvy Renault Llp/s.e.n.c.r.l.,s.r.l.
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