A - Human Necessities – 61 – J
Patent
A - Human Necessities
61
J
A61J 3/02 (2006.01) A61K 9/16 (2006.01) A61K 31/4439 (2006.01)
Patent
CA 2599340
In a production process of granules containing a biologically active substance, variation in the elution profile of the biologically active substance is reduced by heating the temperature of granules to about 50~C or higher and maintaining the temperature for about 1 minute or longer. By setting the spray speed to about 90 mg/min or more per 1 g of cores when a spray agent for a primary agent containing the biologically active substance is sprayed while spraying a binding liquid to the cores and setting the total feeding weight per unit area for a centrifugal fluidized bed coating granulation machine to about 1.5 g/cm2 or more, the variation in the elution profile of the biologically active substance from the granules is reduced.
Selon l~invention, dans un procédé de fabrication de granulés contenant une substance biologiquement active, toute variation du profil d~élution de la substance biologiquement active est réduite en portant la température des granulés à environ 50°C ou davantage et en maintenant la température environ 1 minute ou davantage. En réglant la vitesse de pulvérisation à environ 90 mg/min ou davantage pour 1 g de noyaux pendant la pulvérisation d~un agent de pulvérisation pour agent primaire contenant la substance biologiquement active, tout en pulvérisant un liquide de liaison sur les noyaux et en réglant le poids total d~alimentation pour surface unitaire pour une machine de granulation par enduction de lit fluidifié centrifuge à environ 1,5 g/cm2 ou davantage, on réduit toute variation du profil d~élution de la substance biologiquement active des granulés.
Asakawa Naoki
Nagahara Naoki
Nonomura Muneo
Fetherstonhaugh & Co.
Takeda Pharmaceutical Company Limited
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