A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
167/252, 167/273
A61K 31/135 (2006.01) A61K 9/00 (2006.01) A61K 9/22 (2006.01) A61K 9/24 (2006.01)
Patent
CA 1334382
The present invention relates to a therapeutic delivery system of metoprolol. This delivery system is suitable for the oral administration of metoprolol in a controlled and continuous manner. About 50 to 90 % of the dose of the active agent is released into the gastrointestinal tract at a rate of about 5 to 12 % by weight per hour of the dose to be administered. The oral delivery system (OROS) according to the present invention essentially consists of the following components: a) a tablet core consisting of an osmotically active composition com- prising an effective amount of a pharmaceutically acceptable metoprolol salt in combination with a pharmaceutically acceptable tablet binder, and, optionally, an osmotically active driving agent and/or further pharmaceutically acceptable additives; b) a discrete inner layer of a water-soluble and even coating on the tablet core a) being present in an amount of between about 0.3 % and about 10 % by weight of the core; c) a semipermeable discrete outer layer impermeable to metoprolol and permeable to gastrointestinal fluid, surrounding and adhesively bonded to the inner layer a); and d) at least one passageway through both layers b) and c) for dispensing the active agent metoprolol, in communication with the tablet core a) and the external environment.
597406
Koparkar Arun D.
Shah Shailesh B.
Fetherstonhaugh & Co.
Novartis Ag
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