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filingDate 2002-05-13-04:00^^<http://www.w3.org/2001/XMLSchema#date>
publicationDate 2004-02-18-04:00^^<http://www.w3.org/2001/XMLSchema#date>
publicationNumber AR-034332-A1
titleOfInvention COMPACTION PROCEDURE TO MANUFACTURE A DOSAGE FORM OF SODIUM PHENITOIN
abstract A process for compacting with cylinders and manufacturing a pharmaceutical formulation comprising the steps of adding sodium phenytoin to a bowl of a mixer and adding at least one excipient to the tank. The mixture is homogenized and transferred to a cylinder compactor in which pressure is applied to the mixture of sodium phenytoin and excipient. Next, the resulting compacted material is pissed into a granulate, which is homogenized a second time and which is suitable for further processing in a dosage form. Preferably, the excipients include magnesium stearate, sugar, lactose monohydrate and talc. In an alternative embodiment, talc is added immediately before homogenizing the granulate a second time.
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