Enteric solid oral dosage form of bisphosphonate containing...

Details Enteric solid oral dosage form of bisphosphonate containing... Enteric solid oral dosage form of bisphosphonate containing...

A - Human Necessities

61

K

A61K 9/20 (2006.01) A61K 9/28 (2006.01) A61K 31/00 (2006.01) A61K 31/675 (2006.01)

Patent

CA 2566798

Oral dosage forms of a bisphosphonate comprised of a safe and effective amount of a pharmaceutical composition comprising a bisphosphonate, a chelating agent, and, means for effecting delayed release of the bisphosphonate and the chelating agent in the lower gastrointestinal tract provide delivery of the pharmaceutical composition to the lower gastrointestinal tract of the mammal subject and pharmaceutically effective absorption of the bisphosphonate with or without food or beverages. The present invention substantially alleviates the interaction between bisphosphonates and food or beverages, which interaction results in the bisphosphonate active ingredient not being available for absorption. The resulting oral dosage form may thus be taken with or without food. Further, the present invention effects delivery of the bisphosphonate and the chelating agent to the lower GI tract, substantially alleviating the upper GI irritation associated with bisphosphonate therapies. These benefits simplify previously complex treatment regimens and can lead to increased patient compliance with bisphosphonate therapies.

Des formes de posologies orales d'un diphosphonate constitué d'une quantité sûre et efficace d'une composition pharmaceutique comprenant un diphosphonate, un agent chélateur et un moyen destiné à effectuer une libération retardée du diphosphonate et de l'agent chélateur dans les voies gastro-intestinales inférieures fournissent la délivrance d'une composition pharmaceutique aux voies gastro-intestinales inférieures du sujet mammifère et l'absorption effective en termes pharmaceutiques du diphosphonate avec ou sans nourriture ou boissons. La présente invention atténue sensiblement l'interaction entre les diphosphonates et la nourriture ou les boissons, interaction qui résulte en ce que l'ingrédient actif du diphosphonate n'est pas disponible en vue d'une absorption. La forme de posologie orale résultante peut ainsi être prise avec ou sans nourriture. En outre, la présente invention effectue la délivrance du diphosphonate et de l'agent chélateur aux voies gastro-intestinales (GI) inférieures en atténuant sensiblement l'irritation des voies gastro-intestinales (GI) supérieures associées aux thérapies à base de diphosphonates. Ces avantages simplifient des régimes de traitements précédemment complexes et peuvent conduire à une compliance améliorée du patient avec les thérapies à base de diphosphonates.

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