Pharmaceutical Manufacturing of Crude Drug Powder ―Dry Compacting Method with a Roller Compactor―

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  • 生薬粉末の製剤化 ―ローラーコンパクターを用いた乾式造粒法について―

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<p>Crude drug powders have various particle shapes and properties leading to poor fluidity and strong adhesiveness and those properties make the handling in processing the powders and controlling the qualities of products difficult. The granulation of crude drug seems to be a good procedure to solve the problem.</p><p>In this study, we looked at the pharmaceutical manufacturing of crude drug powder by the dry compacting method. Senna powder was chosen as a model crude drug powder and granulated by roller compactor. The effects of granulating conditions, such as roller pressure or lactose/micro crystalline cellulose (MCC) mixing ratio, on mean diameter, strength and disintegration time of granules was examined and evaluated by multiple regression analysis. The physical properties of tablets made with various granules, binders and disintegrants were also examined and evaluated by multiple regression analysis.</p><p>As a result, we found that the lactose/MCC ratio strongly affected the granule properties, but the roller pressure did not, especially granule disintegration time. We could achieve our goals, about 2.0 kg hardness and less than 1000 sec. disintegration time, by using a formulation of Senna granules consisting of just MCC as an excipient, MCC as a binder and crospovidone (Kollidon CL) as a disintegrant and by tableting at more than 200 MPa.</p>

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