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Claims for Patent: 9,011,926

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Claims for Patent: 9,011,926

Title:Method for producing granules
Abstract: 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.degree. 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/cm.sup.2 or more, the variation in the elution profile of the biologically active substance from the granules is reduced.
Inventor(s): Nagahara; Naoki (Osaka, JP), Asakawa; Naoki (Hikari, JP), Nonomura; Muneo (Osaka, JP)
Assignee: Takeda Pharmaceutical Company Limited (Osaka, JP)
Application Number:14/488,823
Patent Claims: 1. A centrifugal fluidized bed granulation method for granules of an active pharmaceutical ingredient, which comprises spraying or dusting a spraying or dusting material containing an active pharmaceutical ingredient containing a biologically active substance at a spraying or dusting speed of about 90 mg/min or more per 1 g of cores while spraying a binder liquid to cores, wherein a total feeding weight per unit area for a centrifugal fluidized bed coating granulation machine is about 1.5 g/cm.sup.2 or more.

2. The method according to claim 1, wherein the spraying or dusting speed of the spraying or dusting material containing an active pharmaceutical ingredient is from about 90 to about 250 mg/min.

3. The method according to claim 1, wherein the ratio of (spraying or dusting speed of the spraying or dusting material containing an active pharmaceutical ingredient per 1 g of cores)/(linear velocity) is from 0.27 to 2.

4. The method according to claim 1, wherein the total feeding weight per unit area for a centrifugal fluidized bed coating granulation machine is from about 1.5 to about 6 g/cm.sup.2.

5. A granule obtained by the granulation method according to claim 1.
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