Compaction process for manufacture of sodium phenytoin dosage form

滚压和制备药物制剂的方法，所述方法包括下列步骤：将苯妥英钠加到混合机的容器中，向该容器中加入至少一种赋形剂。将混合物掺合，并转移到辊子压缩机上，在辊子压缩机上给苯妥英钠与赋形剂的掺合物施加压力。然后将所得压缩物进行碾磨以形成颗粒，其再次掺合，并且适于进一步加工成剂型。赋形剂优选包括硬脂酸镁、糖、乳糖一水合物和滑石粉。在另一个实施方案中，滑石粉在颗粒再次掺合之前立即加入。 A process for the roller compaction and manufacture of a pharmaceutical formulation comprises the steps of adding sodium phenytoin to a vessel of a blender and adding at least one excipient to the vessel. The mixture is blended and transferred to a roller compactor, where pressure is applied to the blend of sodium phenytoin and excipient. Next, the resultant compaction is milled to form a granulation, which is blended a second time and is suitable for further processing into a dosage form. Preferably, the excipients include magnesium stearate, sugar, lactose monohydrate, and talc. In an alternative embodiment, talc is added immediately prior to the granulation being blended for a second time.