Methods and dosage forms with modified layer geometry

A - Human Necessities – 61 – K

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A61K 9/22 (2006.01) A61K 9/00 (2006.01) A61K 9/24 (2006.01)

Patent

CA 2515641

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 present invention pertains to methods of enhancing release rates by modifying the geometry of core layer interfaces through inversion of the traditional compression sequence in order to alter the mixing of layers during operation and by modifying the composition of core layers such that the viscosity of the hydrated delay layer remains higher than the viscosity of the hydrated drug layer during operation. The result is greater uniformity in the release rate from the core providing a more optimal ascending release rate and consistent performance.

L'invention concerne des formes dosifiées et des méthodes pour une libération modulée de cyclobenzaprine. Ces formes dosifiées à libération prolongée fournissent des concentrations plasmatiques stationnaires moyennes de cyclobenzaprine thérapeutiquement efficaces, lorsqu'elles sont administrées une fois par jour. L'invention concerne des méthodes permettant d'accroître les vitesses de libération par une modification de la géométrie des interfaces de couche de noyau, par une inversion de la séquence de compression classique, de sorte à modifier le mélange des couches lors de cette opération, et par une modification de la composition des couches de noyau, de sorte que la viscosité de la couche de retard hydratée reste supérieure à la viscosité de la couche de médicament hydratée, lors de l'opération. Il en résulte une uniformité supérieure, au niveau de la vitesse de libération, à partir du noyau, ce qui permet d'obtenir une vitesse de libération ascendante plus optimale et une performance homogène.

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