| abstract |
A method for roller compaction and manufacture of a pharmaceutical formulation, comprising adding sodium phenytoin to a container of a blender and adding at least one excipient to the container. The mixture is blended and transferred to a roller press where pressure is applied to the sodium phenytoin and excipient blend. The resulting compact is then ground to form granules, which are blended for a second time to make them suitable for further processing into a dosage form. Preferably, the excipients include magnesium stearate, lactose monohydrate, and talc. In another aspect, talc is added just before the granules are blended for a second time. |