Solid dosage forms of bendamustine

Details Solid dosage forms of bendamustine Solid dosage forms of bendamustine

A - Human Necessities

61

K

A61K 9/20 (2006.01) A61K 9/28 (2006.01) A61K 31/4184 (2006.01)

Patent

CA 2745509

In the present invention there is provided a pharmaceutical composition in a solid dosage form suitable for oral administration, the composition comprising bendamustine or a pharmaceutically acceptable ester, salt or solvate thereof as an active ingredient, and at least one pharmaceutically acceptable excipient, which is a pharmaceutically acceptable saccharide selected from the group consisting of one or more of a monosaccharide, a disaccharide, an oligosaccharide, a cyclic oligosaccharide, a polysaccharide and a saccharide alcohol, wherein the ratio by weight of the active ingredient to the saccharide excipient(s) is in the range of 1 :1-5.

La présente invention porte sur une composition pharmaceutique sous forme posologique solide et appropriée à l'administration par voie orale, ladite composition comprenant de la bendamustine ou un ester, sel ou solvate pharmaceutiquement acceptable de ladite en tant qu'ingrédient actif, et au moins un excipient pharmaceutiquement acceptable, pouvant être un saccharide pharmaceutiquement acceptable sélectionné dans le groupe constitué d'un ou plusieurs des éléments suivants : monosaccharide, disaccharide, oligosaccharide, oligosaccharide cyclique, polysaccharide et alcool de saccharide, le rapport en poids d'ingrédient actif par rapport à l'excipient saccharide ou aux excipients saccharides étant situés dans une plage de 1 :1-5.

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