Oral controlled release tablet

Details Oral controlled release tablet Oral controlled release tablet

A - Human Necessities

61

K

A61K 9/24 (2006.01) A61K 9/36 (2006.01) A61K 31/138 (2006.01) A61K 47/38 (2006.01)

Patent

CA 2715584

The present invention refers to an oral controlled release tablet providing a reduced risk of alcohol induced dose dumping; said tablet comprising: .cndot. a core comprising o a first compressed layer comprising a swelling agent, o a second compressed layer comprising at least one therapeutically active ingredient, and pharmaceutically acceptable excipient wherein at least one excipient is a release rate controlling excipient and wherein the percent by weight of excipients that are soluble in alcohol does not exceed 35 % by weight of the layer, optionally a third compressed layer comprising a swelling agent; and .cndot. a coating surrounding the said core, the coating comprising a polymer insoluble in an aqueous medium comprising from 0 % v/v to 40 % v/v of alcohol, whereby upon contact with aqueous gastrointestinal fluids, the upper compressed layer swells to cause removal of the coating from the upper surface of the upper compressed layer and then said upper layer disintegrates allowing the release of the active ingredient from the defined surface area of the upper surface of said lower compressed layer with the coating covering its bottom and side surfaces.

La présente invention concerne un procédé de réduction du risque de libération massive induite par l'alcool d'un principe thérapeutiquement actif, qui comprend ladministration dun comprimé oral à libération contrôlée à des sujets humains qui ont ingéré de lalcool; ledit comprimé comprenant : un cur comprenant o une couche supérieure compressée comprenant un agent de gonflement, et o une couche inférieure compressée comprenant au moins un principe thérapeutiquement actif, et un excipient pharmaceutiquement acceptable, au moins un excipient étant un excipient contrôlant la vitesse de libération et le pourcentage en poids des excipients qui sont solubles dans l'alcool nexcédant pas 35 % en poids de la couche et; un enrobage entourant ledit cur, lenrobage comprenant un polymère insoluble dans un milieu aqueux comprenant de 0 % p/p à 40 % p/p d'alcool, moyennant quoi sous leffet du contact avec les fluides gastro-intestinaux aqueux, la couche supérieure compressée gonfle et entraîne lélimination de lenrobage de la surface supérieure de la couche supérieure compressée puis ladite couche supérieure se désagrège, permettant la libération du principe actif de laire de surface définie de la surface supérieure de ladite couche inférieure compressée, l'enrobage couvrant ses surfaces inférieure et latérales.

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