Process for the preparation of shaped, compressed...

Details Process for the preparation of shaped, compressed... Process for the preparation of shaped, compressed...

A - Human Necessities

61

K

A61K 9/22 (2006.01) A61K 9/20 (2006.01)

Patent

CA 2085231

A process is disclosed for producing moulded, pressed dose units with retarded release of a therapeutic active ingredient having compression pressure dependent self-retarding properties. In order to produce dose units having a very uniform. essentially linear and reproducible constant release of the active ingredient, the active ingredient is reduced during a first step to particles. with a fraction of an additive that inhibits or compensates its self-retarding properties. so that mouldings formed with these particles with no further additives have a rapid release in relation to the desired retarded release in the pressure range required to compress the dose units. Then, during a second step. the particles are moulded with a retardant into dose units. Corresponding dose units are also disclosed.

Procédé de production d'unités de prise pressées, moulées, à libération retardée, dont l'ingrédient actif thérapeutique a des propriétés d'auto-retardement dépendant de la pression de compression. Afin de produire des unités de prise à libération constante très uniforme, essentiellement linéaire et reproductible, l'ingrédient actif est, dans un premier temps, réduit en particules, auxquelles est ajouté une fraction d'un additif qui inhibe ou compense ses propriétés d'auto-retardement, de sorte que les moulages formés avec ces particules ne contenant pas d'autres additifs aient une libération rapide par rapport à la libération retardée souhaitée dans l'échelle de pression requise pour comprimer les unités de prise. En un second temps, les particules, auxquelles est ajouté une substance retardante, sont moulées pour former des unités de prise. L'invention présente également les unités de prise correspondantes.

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