EP1592410B1 — Methods and dosage forms with modified layer geometry

USPTO Abstract

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.