Dosage forms of risedronate

Details Dosage forms of risedronate Dosage forms of risedronate

A - Human Necessities

61

K

A61K 9/32 (2006.01) A61K 9/36 (2006.01) A61K 9/42 (2006.01) A61K 9/58 (2006.01) A61K 31/675 (2006.01) A61P 19/10 (2006.01)

Patent

CA 2602188

Oral dosage forms of a risedronate comprised of a safe and effective amount of a pharmaceutical composition com- prising risedronate, a chelating agent, and, means for effecting delayed release of the risedronate and the chelating agent in the small intestine provide immediate release of the pharmaceutical composition to the small intestine of the mammal subject and pharmaceu-tically effective absorption of the bisphosphonate with or without food or beverages. The present invention substantially alleviates the interaction between risedronate and food or beverages, which interaction results in the bisphosponate 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 risedronate and the chelating agent to the small intestine, substantially alleviating the upper GI irritation associ-ated with bisphosponate therapies. These benefits simplify previously complex treatment regimens and can lead to increased patient compliance with bisphospanate therapies.

Des formes galéniques à administration orale de risedronate constituées d'une préparation pharmaceutique comprenant une quantité sûre et efficace du risedronate, d'un agent chélatant, et de substances destinées à libérer le risedronate et l'agent chélatant de façon retardée dans l'intestin grêle, permettent la libération immédiate de la préparation pharmaceutique dans l'intestin grêle du sujet mammifère et une absorption pharmaceutiquement efficace du bisphosphonate avec ou sans aliments ou boissons. La présente invention diminue de façon substantielle l'interaction entre le risedronate et les aliments ou boissons, ladite interaction résultant en la non-disponibilité du principe actif de type bisphosphonate pour l'absorption. La forme galénique résultante peut ainsi être prise avec ou sans aliments. En outre, la présente invention permet la libération du risedronate et de l'agent chélatant au niveau de l'intestin grêle, ce qui soulage de façon substantielle l'irritation de l'appareil gastro-intestinal supérieur associée aux thérapies employant des bisphosphonates. Ces avantages permettent de simplifier les régimes de traitement complexes existants et peuvent amener à une amélioration de l'observance des thérapies à base de bisphosphonates par le patient.

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