DISINTEGRATING MONOLITHIC MODIFIED RELEASE TABLETS CONTAINING QUADRI-LAYER EXTENDED RELEASE GRANULES

摘要

The present invention relates to a modified release pharmaceutical formulation comprising one or more sustained release granules that may be prepared by over-mixing and hot melt granulation. The invention also relates to disintegrating monolithic modified release tablets comprising the sustained release granules as an internal phase and an immediate release formulation of a drug or drugs as an external phase. The drug release profile from either these granules or these tables may be adjusted by adjusting the percentages of the formulation's components. In one application, the disintegrating monolithic modified release tablets comprise amoxicillin and clavulanate and have a dissolution profile similar to brand and generic "Augmentin XR® Bilayered Extended Release Tablets (1000 mg/62.5 mg)". The invention also relates to a method of preparing the foregoing sustained release granules.