Pharmaceutical dosage forms comprising tablet core having a...

A - Human Necessities – 61 – K

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

Patent

CA 2476171

A pharmaceutical dosage form comprising: a) a tablet core comprising a pharmaceutically active ingredient and one or more pharmaceutically active ingredient and one or more pharmaceutically acceptable adjuvants, the tablet core having a tensile strength of less than 38 N/cm2 before coating and fusion and b) a coating extending over at least 25% of the surface area of the tablet core, the coating resulting from deposition of a powder comprising fusible particles and fusing the particles to form a coating film, thereby providing the pharmaceutical dosage form with a greater hardness/crush strength than the tablet core. The tablet core may be formed by light compression with enables coated components and fragile components, such as capsules, to be used within the compression blend with little or no damage.

L'invention concerne une forme de dose pharmaceutique comprenant: a) un noyau de tablette constitué d'un principe actif pharmaceutique et d'un ou de plusieurs principes actifs pharmaceutiques et d'un ou de plusieurs adjuvants, acceptables sur le plan pharmaceutique, le noyau de tablette possédant une résistance à la rupture inférieure à 38 N/cm?2¿ avant enrobage et fusion, et b) un enrobage recouvrant au moins 25 % de la surface du noyau de la tablette, cet enrobage résultant du dépôt d'une poudre comprenant des particules fusibles. La fusion de ces particules mène à la formation d'un film d'enrobage, ce qui confère à la forme de dose pharmaceutique une rigidité plus importante et une résistance plus grande à l'écrasement que celles du noyau de la tablette. Le noyau de la tablette peut être formé par une compression légère ce qui permet l'utilisation de composants de revêtement et de composants fragiles, tels que des capsules, dans le mélange de compression sans dommage ou presque.

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