Risedronate delayed-release compositions

A - Human Necessities – 61 – K

Patent

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Details

A61K 31/675 (2006.01) A61K 9/28 (2006.01) A61K 9/30 (2006.01) A61K 9/50 (2006.01) A61K 9/56 (2006.01)

Patent

CA 2122479

The present invention is directed to a novel enteric-coated oral dosage form of a risedronate active ingredient comprised of a safe and effective amount of a pharmaceutical composition which is comprised of a risedronate active ingredient and pharmaceutically-acceptable excipients. Said dosage forms prohibit the exposure of the risedronate active ingredient to the epithelial and mucosal tissues of the buccal cavity, pharynx, esophagus, and stomach and thereby protects said tissues from erosion, ulceration or other like irritation. Accordingly, the said dosage forms effect the delivery to the lower intestinal tract of said human or other mammal of a safe and effective amount of the risedronate active ingredient, and substantially alleviate the esophagitis or esophageal irritation which sometimes accompanies the oral administration of risedronate active ingredients.

Le présent brevet porte sur une nouvelle forme posologique entérosoluble du risédronate et comporte une quantité efficace et sans danger d'une composition pharmaceutique renfermant du risédronate et des excipients acceptables sur la plan pharmaceutique. Ces formes posologiques empêchent l'exposition des tissus de l'épithélium et de la muqueuse de la cavité buccale, du pharynx, de l'oesophage et de l'estomac au risédronate et les protègent contre l'érosion, l'ulcération ou autres formes d'irritation. Par conséquent, ces formes posologiques assurent la diffusion dans le tractus intestinal inférieur de l'être humain ou d'autres mammifères d'une quantité efficace et sans danger de risédronate, et soulage substantiellement l'oesophagite ou l'irritation de l'oesophage qui accompagne parfois l'administration par voie buccale des formes du risédronate.

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