A highly porous, fast-disintegrating solid dosage form and...

A - Human Necessities – 61 – K

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A61K 9/00 (2006.01) A61K 9/14 (2006.01)

Patent

CA 2585426

The invention relates to a method of manufacture of fast-disintegrating solid dosage forms, characterized in that one or more structure building components in mixed solid powder form are dosed into cavities of blister packs or moulds, the remaining components dissolved in water dosed and added to the powder to form a moistened, plasticized mass, frozen to below -20~C , and the water sublimed in high vacuum. In this way solid dosage forms are obtainable with a similar porous structure as usually result from freeze-drying processes, but the process requires much less water, which means considerably less time and less energy.

Procédé de production de formes galéniques solides à désintégration rapide, caractérisé en ce qu'un ou plusieurs constituants de formation de structure sous forme de poudre de solide mélangée sont dosés et introduits dans les cavités de plaquettes alvéolaires ou de moules, et les constituants restants sont dissous dans de l'eau, dosés et ajoutés à la poudre pour former une masse humidifiée sous forme de pâte, congelée ensuite à une température inférieure à -20 °C, l'eau étant sublimée dans un vide élevé. Ledit procédé permet d'obtenir des formes galéniques solides possédant une structure poreuse similaire à celle résultant habituellement de processus de lyophilisation, mais le procédé selon la présente invention nécessite beaucoup moins d'eau, ce qui signifie considérablement moins de temps et moins d'énergie.

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