Opioid analgesic
AssigneeEuro-Celtique S.A.
InventorsWalter Wimmer, Bianca Brogmann, Udo Hahn, Christof Spitzley
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Abstract
The invention is relative to a pharmaceutical preparation, especially for oral administration, with at least one active substance and with formulation components influencing the release of active substance, which preparation comprises at least one opiod analgesic as active substance that is formulated proportionally on the one hand for rapid release and on the other hand for delayed release in such a manner that the in vitro release rate from the preparation according to the Ph. Eur. paddle test shows a mean value of above 40% by weight after one hour and that the in vitro release rate shows a mean value that is still below 80% by weight after four hours.
Claims12
A pharmaceutical preparation for oral administration comprising a bilaminar tablet comprising a rapid release layer comprising tramadol or a pharmaceutically acceptable salt thereof, polyvinylpyrrolidine and microcrystalline cellulose;
- and a delayed release layer comprising tramadol or a pharmaceutically acceptable salt thereof, ethylcellulose, and cetostearyl alcohol said preparation exhibiting an in vitro release rate according to the Ph. Eur. paddle test of a mean value of above 40% by weight after one hour and a mean value of below 80% by weight after four hours.
Dependencies are inferred from the claim text.