Fast dispersing dosage forms free of gelatin

A - Human Necessities – 61 – K

Patent

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Details

A61K 47/36 (2006.01) A61K 9/00 (2006.01) A61K 9/20 (2006.01)

Patent

CA 2360647

The present invention relates to fast dispersing solid dosage forms that preferably dissolve in the oral cavity within sixty (60), more preferably within thirty (30), most preferably within ten (10) seconds. A novel feature of the solid dosage forms according to the invention reside in the fact that the composition is essentially free or absolutely free of mammalian gelatin. It has been discovered that the use of certain modified starches at concentrations from 20 to 90 % by weight of the solid dosage form prepares dosage forms that are mechanically and chemically stable and are able to deliver higher concentrations of an active ingredient than the heretofore utilized gelatin based fast dispersing solid dosage forms. Further, the solid dosage forms according to the invention are obtainable by removing a solvent, such as water, from a mixture comprising an active ingredient, a modified starch and a matrix forming agent via freeze drying.

La présente invention concerne des formes posologiques solides à diffusion rapide qui se dissolvent de préférence dans la cavité buccale en moins de 60 secondes, de préférence moins de 30 secondes, et de façon plus préférentielle en moins de 10 secondes. L'un des traits caractérisant les formes posologiques solides de l'invention réside en ce que la composition est sensiblement, voire totalement exempte de gélatine de mammifère. On a découvert que l'utilisation de certains amidons modifiés intervenant pour 20% à 90% de la masse de la forme posologique solide permet l'obtention de formes posologiques mécaniquement et chimiquement stables capable de libérer des concentrations de principe actif supérieures à ce que permettaient les formes posologiques à libération rapide à base de gélatine utilisées jusqu'à présent. En outre, les formes posologiques solides de l'invention résultent de l'élimination, par lyophilisation, d'un solvant tel que l'eau d'un mélange comprenant un principe actif, un amidon modifié et un agent de construction de matrice.

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