Formulation & dosage form for the controlled delivery of...

A - Human Necessities – 61 – K

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Details

A61K 9/00 (2006.01) A61K 9/127 (2006.01) A61K 47/12 (2006.01) A61K 47/44 (2006.01)

Patent

CA 2471081

The present invention includes a formulation and controlled release dosage form that enable the controlled release of therapeutic agents showing reduced absorption in the lower gastrointestinal tract. The formulation of the present invention includes a therapeutic agent that exhibits greater absorption in the upper GI tract than in the lower GI tract and a permeation enhancer, which serves to increase absorption of the therapeutic agent in the lower GI tract. The formulation of the present invention further includes a carrier that allows the formulation to transition to a bioadhesive gel in situ after the formulation is dispensed within the GI tract and has had some opportunity to reach the surface of the GI mucosal membrane. The bioadhesive gel formed by the formulation of the present invention works to present effective concentrations of both the therapeutic agent and the permeation enhancer at the surface of the GI mucosal membrane over a period. The controlled release dosage form of the present invention is designed to deliver the formulation of the present invention at a desired release rate or release rate profile over a desired period of time.

L'invention concerne une composition et un dosage d'administration contrôlée qui permettent d'administrer de manière contrôlée des agents thérapeutiques dont l'absorption par le tractus gastro-intestinal inférieur est faible. La composition selon l'invention comprend un agent thérapeutique, dont l'absorption par le tractus gastro-intestinal supérieur est plus grande que par le tractus gastro-intestinal inférieur, et un promoteur de perméation qui contribue à augmenter l'absorption de l'agent thérapeutique par le tractus gastro-intestinal inférieur. Cette composition comporte aussi un vecteur qui permet à ladite composition de se transformer en gel bioadhésif in situ, après avoir été délivrée à l'intérieur du tractus gastro-intestinal et après avoir atteint la surface de la muqueuse gastro-intestinale. Le gel bioadhésif formé par ladite composition agit pour maintenir des concentrations efficaces à la fois de l'agent thérapeutique et du promoteur de perméation à la surface de la muqueuse gastro-intestinale pendant un certain temps. Le dosage d'administration contrôlée de cette invention est conçu pour administrer ladite composition selon un taux de libération donné ou selon un profil de taux de libération défini pendant une durée déterminée.

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