Inventors:
George Crotts - Kintnersville PA, US
Mebrahtu Fessehaie - Mineola NY, US
Srinivas Gadiraju - Randolph NJ, US
John Gawel - Clark NJ, US
Isaac Ghebre-Sellassie - Morris Plains NJ, US
Ashlesh Sheth - Randolph NJ, US
International Classification:
A61K009/20, B27N003/00, A61K031/4166
US Classification:
514/389000, 264/109000, 424/465000
Abstract:
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.