Oral dosage form comprising a therapeutic agent and an...

A - Human Necessities – 61 – K

Patent

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A61K 9/22 (2006.01) A61K 9/52 (2006.01)

Patent

CA 2456601

The present invention provides an oral dosage form comprising a first composition and a second composition. The first composition comprises an effective amount of a therapeutic agent and the second composition comprises an effective amount of an adverse-effect agent. The adverse-effect agent is covered with a coating that is substantially insoluble in the gastrointestinal tract. In one embodiment, the adverse-effect agent is coated with an outer base-soluble layer and an inner acid-soluble layer. The therapeutic agent can be uncoated or can be coated with a coating having an outer acid-soluble layer and an inner base-soluble layer. The dosage form discourages administration of the therapeutic agent by other than oral administration.

La présente invention concerne une forme pharmaceutique orale comprenant une première composition et une seconde composition. La première composition comprend une dose efficace d'un agent thérapeutique, et la seconde composition comprend une dose efficace d'un agent anti-effets indésirables. L'agent anti-effets indésirables est enrobé d'un revêtement sensiblement insoluble dans le tractus gastro-intestinal. Dans un mode de réalisation, l'agent anti-effets indésirables est enrobé d'une couche extérieure soluble dans la base, et d'une couche intérieure soluble dans l'acide. L'agent thérapeutique peut être non enrobé, ou enrobé d'un revêtement possédant une couche extérieure soluble dans l'acide et une couche intérieure soluble dans la base. La conception de la forme pharmaceutique décourage l'administration de l'agent thérapeutique autrement que par voie orale.

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