Method for manufacture of extended release dosage form

A process for the dry granulation and manufacture of a pharmaceutical formulation comprises the steps of adding sodium phenytoin to a vessel of a mixer/granulator and adding at least one excipient to the vessel. Heat is then applied from the vessel to the sodium phenytoin and excipient to achieve th...

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Bibliographische Detailangaben
Hauptverfasser: Ha, Qing, Gadiraju, Srinivas, Ifan, Agber, Leung, Sau-Hung, Sabouni, Adam
Format: Patent
Sprache:eng
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Beschreibung
Zusammenfassung:A process for the dry granulation and manufacture of a pharmaceutical formulation comprises the steps of adding sodium phenytoin to a vessel of a mixer/granulator and adding at least one excipient to the vessel. Heat is then applied from the vessel to the sodium phenytoin and excipient to achieve the desired target temperature. Next, while the heat is applied from the vessel, the sodium phenytoin and excipient are mixed and chopped in the vessel to form a granulation suitable for encapsulating into a dosage form. Preferably, the excipients include magnesium stearate, sugar, lactose monohydrate, and talc. In an alternative embodiment, talc is added after chopping and blended into the formulation to form a blend suitable for encapsulating into a dosage form.