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AssigneeNippon Zoki Pharmaceutical Co., Ltd.
InventorsHiroshi Sakamoto, Kunio Komai, Kenji Sakakibara, Hirokazu Banba, Kiyoshi Fukuda
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A method for manufacturing a preparation which contains acetaminophen at a high content, in particular, a miniaturized tablet (conventional tablets, sustained-release tablets, etc.) which have excellent elution properties, preferable hardness and high drug content uniformity, and a premix drug substance of acetaminophen which has improved manufacturability. According to the method in which acetaminophen having a preset particle size is used for manufacturing a preparation, the flowability of acetaminophen can be improved so that secondary agglomeration can be suppressed and manufacturing efficiency can be elevated. Thus, this method is highly useful for manufacturing an acetaminophen preparation having improved administrability, for example, a reduced size.
A method for manufacturing a premix drug substance, wherein the method includes the steps of blending a dispersant in an amount of 0.1 to 3% relative to 100% by weight of the premix drug substance and optionally a solubilizing agent in an amount of 0 to 0.8% by weight relative to 100% by weight of the premix drug substance into unpulverized acetaminophen having a particle size distribution that d10 is 5 to 300 μm, d50 is about 120 to about 500 μm, and d90 is 200 to 900 μm in an amount of 90 to 99.9% by weight relative to 100% by weight of the premix drug substance;
Dependencies are inferred from the claim text.