Methods and dosage forms with modified viscosity layers

A - Human Necessities – 61 – K

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A61K 9/24 (2006.01) A61K 31/135 (2006.01)

Patent

CA 2512786

Dosage forms and methods for providing a modulated release of cyclobenzaprine are provided. The sustained release dosage forms provide therapeutically effective average steady-state plasma cyclobenzaprine concentrations when administered once per day. The composition of the delay layer and the composition of the drug layer are characterized by the viscosity of the hydrated delay layer remaining higher than the viscosity of the hydrated drug layer during operation in one embodiment. The result is greater uniformity in the release rate from the core providing a more optimal ascending release rate. In other embodiments, the hydrated delay layer has a viscosity that is lower than the viscosity of the hydrated drug layer as well as a hydrated delay layer that is substantially similar to the hydrated drug layer.

L'invention concerne des méthodes et des formes posologiques qui assurent une libération modulée de la cyclobenzaprine. Les formes posologiques à libération lente fournissent des concentrations plasmatiques moyennes de la cyclobenzaprine stables et efficaces sur le plan thérapeutique lorsqu'elles sont administrées une fois par jour. La composition de la couche de retard et la composition de la couche de médicament sont caractérisées en ce que, dans un mode de réalisation, la viscosité de la couche de retard hydratée demeure plus élevée que celle de la couche de médicament hydratée pendant le fonctionnement. Le résultat est une plus grande uniformité du taux de libération du noyau, ce qui donne un taux croissant de libération plus optimal. Dans d'autres modes de réalisation, la couche de retard hydratée présente une viscosité inférieure à celle de la couche de médicament hydratée ainsi qu'une couche de retard hydratée sensiblement semblable à la couche de médicament hydratée.

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