METHOD FOR PRODUCING STARCH GRANULES, AND ORALLY DISINITEGRATING TABLET

A method for producing starch granules suitable as an excipient for an orally disintegrating tablet. Fluidized bed granulation is performed by spraying a starch paste in small amounts while a -starch is being fluidized using an air-fluidized bed. Subsequently, fluidized bed drying is performed at a...

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Hauptverfasser: UMEZAKI MASAO, MURASE HIROSHIGE, UNO TOSHIO, NIWA TOSHIYUKI
Format: Patent
Sprache:eng
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Zusammenfassung:A method for producing starch granules suitable as an excipient for an orally disintegrating tablet. Fluidized bed granulation is performed by spraying a starch paste in small amounts while a -starch is being fluidized using an air-fluidized bed. Subsequently, fluidized bed drying is performed at a temperature equal to or higher than the gelatinization temperature of the -starch. This yields starch granules having a high degree of gelatinization in comparison with the amount of α-starch adhered to the -starch by the spraying of the starch paste. These starch granules alone impart satisfactory oral disintegratability and breaking strength to the tablet. Accordingly, when used as an excipient during tableting of orally disintegrating tablets, other auxiliary excipients such as saccharides or crystalline cellulose need not be added.